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Human immunodeficiency virus (HIV) is an infection that attacks the body’s immune system, specifically the white blood cells called CD4 cells. HIV destroys these CD4 cells, weakening a person’s immunity against opportunistic infections, such as tuberculosis and fungal infections, severe bacterial infections and some cancers.

WHO recommends that every person who may be at risk of HIV should access testing. People at increased risk of acquiring HIV should seek comprehensive and effective HIV prevention, testing and treatment services.  HIV infection can be diagnosed using simple and affordable rapid diagnostic tests, as well as self-tests. It is important that HIV testing services follow the 5Cs: consent, confidentiality, counselling, correct results and connection with treatment and other services. 

People diagnosed with HIV should be offered and linked to antiretroviral treatment (ART) as soon as possible following diagnosis and periodically monitored using clinical and laboratory parameters, including the test to measure virus in the blood (viral load). If ART is taken consistently, this treatment also prevents HIV transmission to others.

At diagnosis or soon after starting ART, a CD4 cell count should be checked to assess a person’s immune status. The CD4 cell count is a blood test used to assess progression of HIV disease, including risk for developing opportunistic infections and guides the use of preventive treatment. The normal range of CD4 count is from 500 to 1500 cells/mm3 of blood, and it progressively decreases over time in persons who are not receiving or not responding well to ART. If the person’s CD4 cell count falls below 200, their immunity is severely compromised, leaving them susceptible to infections and death. Someone with a CD4 count below 200 is described as having an advanced HIV disease (AHD) .

HIV viral load measures the amount of virus in the blood. This test is used to monitor the level of viral replication and effectiveness of ART. The treatment goal is to reduce the viral load in the blood to undetectable levels (less than 50 copies/ml), and the persistent presence of detectable viral load (greater than 1000 copies/ml) in people living with HIV on ART is an indicator of inadequate treatment response and the need to change or adjust the treatment regimen. 

WHO’s 2022–2030 global health sector strategy on HIV  aims to reduce HIV infections from 1.5 million in 2020 to 335 000 by 2030, and deaths from 680 000 in 2020 to under 240 000 in 2030.

Many people do not feel symptoms of HIV in the first few months after infection and may not know that they are infected. Others may experience influenza-like symptoms, including fever, headache, rash and sore throat. However, these first few months are when the virus is most infectious.

As the disease progresses, symptoms will be expanded and more pronounced. These can include swollen lymph nodes, weight loss, fever, diarrhoea and cough. HIV weakens the body’s ability to fight other infections, and without treatment people will become more susceptible to other severe illnesses such as tuberculosis , cryptococcal meningitis, bacterial infections and some cancers including lymphomas and Kaposi’s sarcoma.

Diagnosis of HIV uses rapid tests that provide same-day results and can  be done at home, although a laboratory test is required to confirm the infection. This early identification greatly improves treatment options and reduces the risk of transmission to other people including sexual or drug-sharing partners.

HIV is fully preventable. Effective antiretroviral treatment (ART) prevents HIV transmission from mother to child during pregnancy, delivery and breastfeeding. Someone who is on antiretroviral therapy and virally suppressed will not pass HIV to their sexual partners.

Condoms prevent HIV and other sexually transmitted infections, and prophylaxis use antiretroviral medicines to prevent HIV. Male circumcision is recommended in high-burden countries in eastern and southern Africa. Harm reduction (needle syringe programmes and opioid substitution therapy) prevents HIV and other blood-borne infections for people who inject drugs .

HIV is treated with antiretroviral therapy consisting of one or more medicines. ART does not cure HIV but reduces its replication in the blood, thereby reducing the viral load to an undetectable level.

ART enables people living with HIV to lead healthy, productive lives. It also works as an effective prevention, reducing the risk of onward transmission by 96% .

ART should be taken every day throughout the person’s life. People can continue with safe and effective ART if they adhere to their treatment. In cases when ART becomes ineffective - HIV drug resistance - due to reasons such as lost contact with health care providers and drug stockouts, people will need to switch to other medicines to protect their health.

• HIV and AIDS
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• Global health sector strategies on HIV, viral hepatitis and sexually transmitted infections, for the period 2016–2021 (WHA69.22)
• Global health sector strategy on HIV/AIDS, 2011–2015 (WHA64.14)
• Global health-sector strategy for HIV/AIDS (WHA56.30)
• HIV/AIDS: confronting the epidemic (WHA53.14)
• Global HIV, Hepatitis and STIs Programmes
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National HIV/AIDS Strategy (2022-2025)

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Want to stay abreast of changes in prevention, care, treatment or research or other public health arenas that affect our collective response to the HIV epidemic? Or are you new to this field?

HIV.gov curates learning opportunities for you, and the people you serve and collaborate with.

Stay up to date with the webinars, Twitter chats, conferences and more in this section.

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New: NHAS 2023 Interim Action Report

The White House published the National HIV/AIDS Strategy 2023 Interim Action Report  (PDF 387 KB) on December 1, 2023, highlighting actions taken by federal partners during FY22 and FY23 to move the nation closer to reaching the four goals laid out in the Strategy.

What Is the National HIV/AIDS Strategy?

The National HIV/AIDS Strategy for the United States (2022–2025 ) was published in December 2021 and provides stakeholders across the nation with a roadmap to accelerate efforts to end the HIV epidemic in the country by 2030.

The Strategy reflects President Biden’s commitment to re-energize and strengthen a whole-of-society response to the epidemic while supporting people with HIV and reducing HIV-associated morbidity and mortality.

The White House’s Office of National AIDS Policy (ONAP), part of the Domestic Policy Council, facilitated development of and published the Strategy, which builds on the 2021 HIV National Strategic Plan and the two prior National HIV/AIDS Strategies (2010, 2015).

Key Elements of the National HIV/AIDS Strategy

The Strategy articulates a clear vision to guide the nation’s response to HIV:

The Strategy sets bold targets for ending the HIV epidemic in the United States by 2030, including a 75% reduction in new HIV infections by 2025 and a 90% reduction by 2030. To guide the nation toward realizing the vision, the Strategy focuses on four goals:

• Prevent new HIV infections.
• Improve HIV-related health outcomes of people with HIV.
• Reduce HIV-related disparities and health inequities.
• Achieve integrated, coordinated efforts that address the HIV epidemic among all partners and stakeholders.

Objectives & Strategies

For stakeholders across the nation, the Strategy details 21 objectives and 78 strategies for federal and nonfederal stakeholders to implement to achieve the goals.

Priority Populations

The Strategy d esignates five priority populations disproportionately impacted by HIV so that federal agencies and other stakeholders can focus efforts and resources to achieve the greatest impact. The populations are:

• gay, bisexual, and other men who have sex with men, in particular Black, Latino, and American Indian/Alaska Native men;
• Black women;
• transgender women;
• youth aged 13–24 years; and
• people who inject drugs.

Indicators of Progress

To monitor national progress toward its goals, the Strategy

• identifies eight core indicators,
• establishes a disparity indicator stratified by the priority populations to measure progress toward reducing significant HIV-related disparities, and
• incorporates five indicators focused on quality of life among people with HIV.

Read a factsheet “National HIV/AIDS Strategy: What You Need to Know.”

View the NHAS At-a-Glance that summarizes the goals, objectives, strategies , and indicators of progress.

How Was the Strategy Developed?

ONAP developed the current Strategy in the latter half of 2021, informed by significant input from community stakeholders, including people living with HIV, and supported by federal partners from nine federal Departments whose programs, policies, services, or activities contribute to our national response to HIV. The Strategy builds on the progress achieved and lessons learned from the prior national strategies and seeks to leverage new tools and opportunities to address the challenges that remain.

Learn about the prior National HIV/AIDS Strategies .

Visit HIV.gov’s page about how the NHAS is being implemented.

• Read blog posts related to the NHAS .
• View a video of the NHAS release at the 2021 White House World AIDS Day event Exit Disclaimer .
• Read remarks by President Biden to Commemorate 2021 World AIDS Day, Launch the National HIV/AIDS Strategy, and Kick Off the Global Fund Replenishment Process .
• Read HHS Secretary Becerra’s remarks at the 2021 White House World AIDS Day event where the NHAS was released.
• Download a White House fact sheet: The Biden-⁠Harris Administration Marks World AIDS Day 2021 With Renewed Commitments to Ending the HIV/AIDS Epidemic by 2030 .
• Read a roundup of news coverage highlights about President Biden commemorating World AIDS Day and launching the new National HIV/AIDS Strategy .
• View HIV.gov’s webinar on how to use the National HIV/AIDS Strategy .

Related HIV.gov Blogs

Watch highlights from opening day at uscha 2024, uscha participants invited to share input on 2026-2030 national hiv/aids strategy and national strategic plans for stis, vaccines, and viral hepatitis, onap and pacha acknowledge fundacion latinoamericana de accion social’s 30th anniversary.

• NHAS National HIV AIDS Strategy

Introduction to HIV/AIDS

AIDS stands for Acquired Immune Deficiency Syndrome. AIDS is a serious condition that weakens the body's immune system, leaving it unable to fight off illness.

AIDS is the last stage in a progression of diseases resulting from a viral infection known as the Human Immunodeficiency Virus (HIV or AIDS virus). The diseases include a number of unusual and severe infections, cancers and debilitating illnesses, resulting in severe weight loss or wasting away, and diseases affecting the brain and central nervous system.

There is no cure for HIV infection or AIDS nor is there a vaccine to prevent HIV infection. However, new medications not only can slow the progression of the infection, but can also markedly suppress the virus, thereby restoring the body’s immune function and permitting many HIV-infected individuals to lead a normal, disease-free life.

How HIV/AIDS Affects The Body

The immune system is a network of cells, organs and proteins that work together to defend and protect the body from potentially harmful, infectious microorganisms (microscopic life-forms), such as bacteria, viruses, parasites and fungi. The immune system also plays a critical role in preventing the development and spread of many types of cancer .

When the immune system is missing one or more of its components, the result is an immunodeficiency disorder. AIDS is an immunodeficiency disorder.

Lymphocytes (white blood cells) are one of the main types of immune cells that make up the immune system. There are two types of lymphocytes: B cells and T cells. (T cells are also called CD4 cells, CD4 T cells, or CD4 cell lymphocytes). B cells secrete antibodies (proteins) into the body's fluids to ambush and attack antigens (foreign proteins such as bacteria, viruses or fungi). T cells directly attack and destroy infected or malignant cells in the body.

There are two types of T cells: helper T cells and killer T cells. Helper T cells recognize the antigen and activate the killer T cells. Killer T cells then destroy the antigen.

When HIV is introduced into the body, this virus is too strong for the helper T cells and killer T cells. The virus then invades these cells and starts to reproduce itself, thereby not only killing the CD4 T cells, but also spreading to infect otherwise healthy cells.

The HIV virus cannot be destroyed and lives in the body undetected for months or years before any sign of illness appears. Gradually, over many years or even decades, as the T cells become progressively destroyed or inactivated, other viruses, parasites or cancer cells (called "opportunistic diseases") which would not have been able to get past a healthy body's defense, can multiply within the body without fear of destruction. Commonly seen opportunistic diseases in persons with HIV infection include: pneumocystis carinii pneumonia , tuberculosis, candida (yeast) infection of the mouth, throat or vagina, shingles , cytomegalovirus retinitis and Kaposi's sarcoma.

AIDS is transmitted via three main routes:

The most common mode of transmission is the transfer of body secretions through sexual contact. This is accomplished through exposure of mucous membranes of the rectum, vagina or mouth to blood, semen or vaginal secretions containing the HIV virus.

Blood or blood products can transmit the virus, most often through the sharing of contaminated syringes and needles.

HIV can be spread during pregnancy from mother to fetus.

You cannot get AIDS/HIV from touching someone or sharing items, such as cups or pencils, or through coughing and sneezing. Additionally, HIV is not spread through routine contact in restaurants, the workplace or school. However, sharing a razor does pose a small risk in that blood from a minor nick can be transmitted from one person to another.

Immediately following infection with HIV, most individuals develop a brief, nonspecific “viral illness” consisting of low grade fever, rash, muscle aches, headache and/or fatigue. Like any other viral illness, these symptoms resolve over a period of five to 10 days. Then for a period of several years (sometimes as long as several decades), people infected with HIV are asymptomatic (no symptoms). However, their immune system is gradually being destroyed by the virus. When this destruction has progressed to a critical point, symptoms of AIDS appear. These symptoms are as follows:

extreme fatigue

rapid weight loss from an unknown cause (more than 10 lbs. in two months for no reason)

appearance of swollen or tender glands in the neck, armpits or groin, for no apparent reason, lasting for more than four weeks

unexplained shortness of breath, frequently accompanied by a dry cough, not due to allergies or smoking

persistent diarrhea

intermittent high fever or soaking night sweats of unknown origin

a marked change in an illness pattern, either in frequency, severity, or length of sickness

appearance of one or more purple spots on the surface of the skin, inside the mouth, anus or nasal passages

whitish coating on the tongue, throat or vagina

forgetfulness, confusion and other signs of mental deterioration

It can take as short as a year to as long as 10 to 15 years to go from being infected with HIV to "full-blown" AIDS.

According to the Center for Disease Control and Prevention, a person is considered to have AIDS when they have a T cell count (also called CD4 cell count) of 200 or less (healthy T cell levels range from 500 to 1500) or they have an AIDS-defining condition. The AIDS-defining conditions are:

· Candidiasis

· Cervical cancer (invasive)

· Coccidioidomycosis, Cryptococcosis, Cryptosporidiosis

· Cytomegalovirus disease

· Encephalopathy (HIV-related)

· Herpes simplex (severe infection)

· Histoplasmosis

· Isosporiasis

· Kaposi's sarcoma

· Lymphoma (certain types)

· Mycobacterium avium complex

· Pneumocystis carinii pneumonia

· Pneumonia (recurrent)

· Progressive multifocal leukoencephalopathy

· Salmonella septicemia (recurrent)

· Toxoplasmosis of the brain

· Tuberculosis

· Wasting syndrome

People who are not infected with HIV may also develop these diseases; the presence of any one of these conditions does not mean the person has AIDS. To be diagnosed with AIDS, a person must be infected with HIV.

Some people infected with HIV may develop a disease that is less serious than AIDS, referred to as AIDS Related Complex (ARC). ARC is a condition caused by the AIDS virus in which the patient tests positive for AIDS infection and has a specific set of clinical symptoms. However, ARC patients' symptoms are often less severe than those with classic AIDS because the degree of destruction of the immune system has not progressed as far as it has in patients with classic AIDS.

Symptoms of ARC may include loss of appetite, weight loss, fever, night sweats, skin rashes, diarrhea, tiredness, lack of resistance to infection or swollen lymph nodes .

Note: Not everyone who has been infected with HIV develops AIDS. Very rarely, some individuals can be infected with HIV yet maintain normal immune function and general good health even after 20 years of infection.

Screening for HIV infection is most commonly done by testing blood for HIV antibodies. A newer test, the Orasure test, involves collecting secretions between the cheek and gum and evaluating them for HIV antibodies. Orasure is essentially as accurate as a blood test, and, because it doesn't involve a needle stick, it is favored by many individuals. Orasure is available through physicians’ offices and many public health clinics. Finally, a new urine test available for screening, although if the test is positive, blood tests need to be performed for confirmation of the presence of HIV.

In 1996, a home HIV blood test (called Home Access) became available to the public. These home kits are available in pharmacies and by mail. The kit contains a few sharp tools called lancets, a piece of blotting paper marked with a unique identification number and a prepaid return envelope with a protective pouch. After pricking the finger with the lancet, a few drops of blood are blotted onto the paper, sealed into the envelope and sent to the address on the envelope. In about a week, the person calls a toll-free number to get the results of the test.

Anti-HIV (also called antiretroviral) medications are used to control the reproduction of the virus and to slow or halt the progression of HIV-related disease. When used in combinations, these medications are termed Highly Active Antiretroviral Therapy (HAART). HAART combines three or more anti-HIV medications in a daily regimen, sometimes referred to as a "cocktail". Anti-HIV medications do not cure HIV infection and individuals taking these medications can still transmit HIV to others. Anti-HIV medications approved by the U.S. Food and Drug Administration (FDA) fall into four classes:

1 . Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs), such as nevirappine (Viramune) and efavirenz (Sustiva), bind to and block the action of reverse transcriptase, a protein that HIV needs to reproduce.

2 . Nucleoside Reverse Transcriptase Inhibitors (NRTIs), such as zidovudine (Retrovir), tenofovir DF (Viread), and stavudine (Zerit), are faulty versions of building blocks that HIV needs to make more copies of itself. When HIV uses an NRTI instead of a normal building block, reproduction of the virus is stalled.

3 . Protease Inhibitors (PIs), such as lopinavir/ritonavir (Kaletra), disable protease, a protein that HIV needs reproduce itself.

4 . Fusion Inhibitors, such as enfuvirtide (Fuzeon ), are newer treatments that work by blocking HIV entry into cells.

(View more complete list of HIV drugs).

How many pills you will need to take and how often you will take them depends on what medications you and your doctor choose.

There is no one "best" regimen. You and your doctor will decide which medications are right for you. For people taking HAART for the first time, the recommended regimens are:

Sustiva + Truvada, Sustiva + Epzicom, or Atripla

Kaletra + Truvada, Kaletra + Epzicom, or Kaletra + Combivir

In general, taking only one or two drugs is not recommended because any decrease in viral load is almost always temporary without three or more drugs. The exception is the recommendation for pregnant women, who may take Combivir plus nevirapine to reduce the risk of passing HIV to their infants. If you are pregnant or considering becoming pregnant, there are additional treatment considerations. Recently, a number of drugs have been developed that combine two or even three separate medications in a single pill. Some of these, such as Truvada (emtricitabine + tenofovir) and Epzicom (abacavir + lamivudine) need be taken only once daily. Atripla (emtricitabine + tenofovir + efavirenz) combines three drugs in one pill and needs to be taken only once daily, thereby providing a complete HAART regimen with one pill once daily.

The treatment of HIV infection and AIDS is in a highly dynamic state. Individuals with this condition are advised to seek out experts in their local community who are current with the latest modes of therapy and ongoing clinical trials for evaluating newer therapies.

HIV/AIDS Medications

The following is a partial list of drugs approved for the treatment of HIV infection.

Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Delavirdine (Rescriptor, DLV) Pfizer

Efavirenz (Sustiva, EFV) Bristol-Myers Squibb

Nevirapine (Viramune, NVP) Boehringer Ingelheim

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Abacavir (Ziagen, ABC) GlaxoSmithKline

Abacavir,Lamivudine, Zidovudine (Trizivir) GlaxoSmithKline

Didanosine (Videx, ddI, Videx EC) Bristol-Myers Squibb

Emtricitabine (Emtriva, FTC, Coviracil) Gilead Sciences

Lamivudine (Epivir, 3TC) GlaxoSmithKline

Lamivudine, Zidovudine (Combivir) GlaxoSmithKline

Stavudine ( Zerit, d4T) Bristol-Myers Squibb

Tenofovir DF (Viread, TDF) Gilead Sciences

Zalcitabine (Hivid, ddC) Hoffmann-La Roche

Atripla (tenofovir, emtricitabine, efavirenz) Gilead Sciences

Zidovudine (Retrovir, AZT, ZDV) GlaxoSmithKline

Protease Inhibitors (PIs)

Amprenavir (Agenerase, APV) GlaxoSmithKline, Vertex Pharmaceuticals

Atazanavir (Reyataz, ATV) Bristol-Myers Squibb

Fosamprenavir (Lexiva, FPV) GlaxoSmithKline, Vertex Pharmaceuticals

Indinavir (Crixivan, IDV) Merck

Lopinavir, Ritonavir (Kaletra, LPV/r) Abbott Laboratories

Nelfinavir (Viracept, NFV) Agouron Pharmaceuticals

Ritonavir (Norvir, RTV) Abbott Laboratories

Saquinavir (Fortovase, SQV) Invirase Hoffmann-La Roche

Tipranavir (Aptivus) Boehringer-Ingelheim

Darunavir (Prezista) Tibotec Therapeutics

Fusion Inhibitors

Enfuvirtide (Fuzeon, T-20) Hoffmann-La Roche, Trimeris

Risk Prevention

The only way to protect from contracting AIDS sexually is to abstain from sex outside of a mutually faithful relationship with a partner whom the person knows is not infected with the AIDS virus. Otherwise, risks can be minimized if they:

Don't have sexual contact with anyone who has symptoms of AIDS or who is a member of a high risk group for AIDS.

Avoid sexual contact with anyone who has had sex with people at risk of getting AIDS.

Don't have sex with prostitutes.

Avoid having sex with anyone who has multiple and/or anonymous sexual partners.

Avoid oral, genital and anal contact with partner's blood, semen, vaginal secretions, feces or urine. Unless they know with absolute certainty that their partner is not infected, a latex condom should be used during each sexual act, from start to finish. The use of a spermicidal agent may provide additional protection.

Avoid anal intercourse altogether.

Don't share toothbrushes, razors or other implements that could become contaminated with the blood of anyone who is or might be infected with the AIDS virus.

Exercise caution regarding procedures, such as acupuncture, tattooing, ear piercing, etc., in which needles or other nonsterile instruments may be used repeatedly to pierce the skin and/or mucous membranes.

Such procedures are safe if proper sterilization methods are employed or disposable needles are used. Ask what precautions are taken before undergoing such procedures.

If an individual is scheduling surgery in the near future, and is able, they could consider donating blood for their own use. This will eliminate completely the already very small risk of contracting AIDS through a blood transfusion. It will also eliminate the risk of contracting other bloodborne diseases (such as hepatitis) from a transfusion.

If a person is an IV drug user, adhere to the prevention tips mentioned earlier, as well as:

Get professional help for terminating the drug habit.

Do not share needles or syringes. Be aware that some street sellers are resealing previously used needles and selling them as new.

Clean the needle before using.

Some people apparently remain well after infection of the AIDS virus. They may have no physically apparent symptoms of illness. However, if proper precautions are not used with sexual contacts and/or intravenous drug use, these infected individuals can spread the virus to others .

Anyone who thinks he or she is infected, or who is involved in high-risk behaviors, should not donate his/her blood, organs, tissues, or sperm as they may now contain the AIDS virus.

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A global epidemic and the leading cause of death in some countries.

By: Max Roser and Hannah Ritchie

This page was first published in November 2014 and last revised in December 2023.

Infection with HIV (human immunodeficiency virus) can lead to AIDS (acquired immunodeficiency syndrome). AIDS results in a gradual and persistent decline and failure of the immune system, resulting in a heightened risk of life-threatening infection and cancers .

In the majority of cases, HIV is a sexually transmitted infection. However, HIV can also be transmitted from mother to child, during pregnancy or childbirth, or through breastfeeding. Non-sexual transmission can also occur by sharing injection equipment such as needles.

Other research and writing on HIV/AIDS on Our World in Data:

Antiretroviral therapy has saved millions of lives from AIDS and could save more

See all interactive charts on HIV/AIDS ↓

HIV/AIDS is one of the world's most fatal infectious disease

Almost 1 million people die from hiv/aids each year; in some countries, it's the leading cause of death.

HIV/AIDS is one of the world's most fatal infectious diseases – particularly across Sub-Saharan Africa, where the disease has had a massive impact on health outcomes and life expectancy in recent decades.

The Global Burden of Disease is a major global study on the causes of death and disease published in the medical journal The Lancet . 1 These estimates of the annual number of deaths by cause are shown here. This chart shows the global total but can be explored for any country or region using the "Change country" button.

According to the Global Burden of Disease study, nearly a million people die yearly from HIV/AIDS. To put this into context: this is just over 50% higher than the number of deaths from malaria . It's one of the largest killers globally, but for some countries – particularly across Sub-Saharan Africa, it's the leading cause of death.

The global distribution of deaths from HIV/AIDS

In some countries, hiv/aids is the cause of a quarter of all deaths.

Globally, around 1.5% of deaths are caused by HIV/AIDS.

This share is high but masks the wide variations in the toll of HIV/AIDS worldwide. In some countries, this share was much higher.

On this interactive map, we see the share of deaths that resulted from HIV/AIDS across the world. Across most regions, the share was low: across Europe, for example, it accounted for less than 0.1% of deaths.

However, the share is very high across some countries – focused primarily in Southern Sub-Saharan Africa.

Death rates are high across Sub-Saharan Africa

The significant health burden of HIV/AIDS across Sub-Saharan Africa is also reflected in death rates. Death rates measure the number of deaths from HIV/AIDS per 100,000 individuals in a country or region.

In the interactive map, we see the distribution of death rates worldwide. Most countries have a rate of less than 10 deaths per 100,000 – often much lower, below 5 per 100,000. Across Europe, the death rate is less than one per 100,000.

Across Sub-Saharan Africa, the rates are much higher. Some countries in the South of the region have rates greater than 100 per 100,000.

Death rates are highest for younger adults and children under five years old

Which population groups are most at risk from HIV/AIDS?

In the chart, we show death rates by age group. Here we see that the most at-risk group is younger adults (15 to 49-year-olds). Since HIV is primarily a sexually transmitted infection, where unsafe sex is a primary risk factor, this is what we would expect.

But we also see that death rates are higher for children under five; that’s because HIV can be transmitted from mother to child if the mother is infected.

Is the world making progress in its fight against HIV/AIDS?

How have cases and deaths changed over time.

The 1990s saw a substantial increase in people infected with HIV and dying of AIDS.

In the second half of that decade, over 3 million people were infected with HIV yearly. Since then, the number of new infections began to decline, and it's now below 2 million, the lowest number of new infections since 1990.

As for mortality, AIDS-related deaths increased throughout the 1990s and peaked in the mid-2000s, with nearly 2 million annual deaths. Since then, the annual number of deaths from AIDS has declined and since halved. 2016 was the first year since the peak in which fewer than 1 million people died from AIDS.

The chart also shows the continuing increase in the number of people living with HIV. The growth rate has slowed compared to the 1990s, but the absolute number is at the highest ever.

Global deaths from HIV/AIDS halved within a decade

The world has made significant progress against HIV/AIDS. Global deaths from AIDS have halved over the past decade.

In the visualization, we see the global number of deaths from HIV/AIDS in recent decades – this is shown by age group. In the mid-2000s, global deaths peaked at almost 2 million per year.

Driven mainly by the development and availability of antiretroviral therapy (ART), global deaths have more than halved since then.

You can explore this change for any country or region using the "Edit countries" button on the interactive chart.

HIV/AIDS once accounted for a large share of deaths in some countries, but rates are now falling

Global progress on HIV/AIDS has been driven by significant improvements in the countries most affected by the epidemic.

Today, the share of deaths remains high: more than 1 in 5 deaths in some countries are caused by HIV/AIDS. But in the past, this share was even higher.

In the visualization, we see the change in the share of deaths from HIV/AIDS over time. From the 1990s through to the early 2000s, it was the cause of more than 1 in 3 deaths in several countries and even more than half of annual deaths in the late 1990s in Zimbabwe.

Over the past decade, this share has fallen as antiretroviral treatment has become more widely available.

HIV/AIDS has had a significant impact on life expectancy across Sub-Saharan Africa

The health and mortality burden of HIV/AIDS across Sub-Saharan Africa has been considerable. We see this impact on health reflected in trends in life expectancy . In the visualization, we show changes in life expectancy across select countries in Sub-Saharan Africa for which HIV/AIDS has had the most significant toll.

We see a dramatic drop in life expectancy starting around 1990, coinciding with the rise of HIV. In Botswana, life expectancy fell by a decade; in Eswatini, it fell by two decades. Since the early 2000s — as progress has been made in tackling HIV — we see that life expectancy has been rising again.

In some countries, life expectancy is higher than before the epidemic began.

The prevalence of HIV/AIDS

Prevalence in the total population, share of the population with hiv.

You can explore the total number of people living with HIV/AIDS worldwide here .

Number of new infections each year

Prevalence by gender, is hiv/aids more common in men or women.

There are differences in the prevalence of HIV and death rates from AIDS between men and women. The chart shows the share of women in populations living with HIV.

As we see, HIV prevalence tends to be higher in women across Sub-Saharan Africa, although higher in males across most other regions. The trend in AIDS-related deaths shows the opposite: more men tend to die from AIDS every year than women. The reasons for differences in prevalence and death rates are complex; however, across Sub-Saharan Africa, women tend to be infected with HIV earlier than men and survive longer (explaining both the higher prevalence and lower annual AIDS deaths in women). Several gender inequality and social norm issues result in a higher prevalence of HIV in females across many countries; women are at greater risk when they have a limited role in sexual decision-making and protection, lower rates of sexual education, and higher rates of transactional sex 2 .

Prevalence in children

Share of children infected with hiv, children living with hiv.

When children are infected with HIV, transmission has typically occurred from the mother either during pregnancy or childbirth or through breastfeeding. This is called mother-to-child-transmission, or MTCT. This map shows the total number of children aged 14 and under living with HIV. Globally the number of children living with HIV peaked in 2005 at approximately 2.6 million.

New HIV infections in children

The map shows the total number of children newly infected with HIV yearly. Globally — with similar trends at national levels — the number of new infections in children peaked around the early 2000s (with over 500,000 new infections per year globally), followed by a rapid decline over the last decade.

Children orphaned from AIDS

Some children have lost either one or both parents to AIDS. This does not necessarily imply that children orphaned by AIDS have HIV themselves (although, in some cases, HIV has been transmitted from mother to child). The chart shows the number of children (aged 17 and under) orphaned from AIDS deaths.

Tuberculosis among people living with HIV

Tuberculosis (TB) is the leading HIV-associated opportunistic infection in low- and middle-income countries, and it is a leading cause of death globally among people living with HIV. Death due to tuberculosis remains high among people living with HIV. However, the number of deaths is decreasing. Most of the global mortality due to TB among those with HIV is from cases in Sub-Saharan Africa.

The charts here show the number of TB patients who tested positive for HIV, the number receiving antiretroviral therapy, and the number of TB-related deaths among those living with HIV.

What can be done to prevent HIV/AIDS?

Antiretroviral therapy.

A couple of decades ago, the chances of surviving more than ten years with HIV were slim. Today, thanks to antiretroviral therapy (ART), people with HIV/AIDS can expect to live long lives.

ART is a long-term medical treatment for HIV/AIDS. It works by suppressing the virus from multiplying in the body. This keeps the infection under control and helps to prevent the disease from progressing. ART is essential in progressing against HIV/AIDS because it saves lives, allows people with HIV to live longer, and prevents new HIV infections. Read more in our article:

38 million people had HIV/AIDS in 2020. A couple of decades ago, the chances of surviving more than ten years with HIV were slim. Today, thanks to antiretroviral therapy (ART), people with HIV/AIDS can expect to live long lives. How many lives has ART saved?

Prevention of mother-to-child transmission (PMTCT)

Given that most AIDS cases in children are due to the virus transmission from mother to child during pregnancy, stopping mother-to-child transmission is critical to preventing children from getting infected with HIV.

The chances of an HIV-positive mother transmitting the virus to a child are between 15% and 45%. Effective prevention of mother-to-child transmission (PMTCT) services can reduce the chances of transmission to newborns down to 5%. 3

PMTCT services include preventative measures such as antiviral therapy for mothers and newborns, correct breastfeeding practices, and early child testing for HIV infection.

This visualization shows the number of child infections averted by ART coverage in mothers.

You can explore the number of new HIV infections prevented by PMTCT as a result of antiretroviral therapy across the world here .

Coverage of ART in pregnant women

This map shows the share of pregnant women infected with HIV who receive antiretroviral therapy – a vital intervention to prevent the transmission from mother to child.

Unsafe sex is a leading risk factor for death in Sub-Saharan Africa

Share of people practicing safe sex.

The majority of HIV infections are transmitted through sexual activity.

Sexual transmission can be prevented through condom use (both in heterosexual and homosexual relationships). In the charts here, we see the prevalence of condom use, particularly in cases of “high-risk sex”, which is defined by this data’s source as non-marital, non-cohabiting sexual partner.

Education on HIV/AIDS

Funding to support efforts against hiv/aids, funding needs to meet hiv targets, comparisons of unaids and ihme estimates.

Several sources publish estimates on HIV and AIDS. Two of the most established sources, presented on this page, are UNAIDS and the Institute of Health Metrics and Evaluation (IHME). The charts below show a comparison of these two sources' estimates.

Prevalence of HIV

Incidence/new cases of hiv, interactive charts on hiv / aids.

The latest study can be found at the website of the Lancet here: TheLancet.com/GBD

The 2017 study was published in the following publication: "Roth, G. A., Abate, D., Abate, K. H., Abay, S. M., Abbafati, C., Abbasi, N., ... & Abdollahpour, I. (2018). Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet , 392(10159), 1736-1788". It is online here .

Greig, A., Peacock, D., Jewkes, R., & Msimang, S. (2008). Gender and AIDS: time to act.  AIDS (London, England) ,  22 (Suppl 2), S35. Available online .

World Health Organization (WHO)  'Mother-to-child transmission of HIV'  [accessed November 2019]

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HIV Prevention

The basics of hiv prevention.

• Protect yourself during sex: To reduce your risk of getting HIV, use  condoms  correctly every time you have sex.
• Protect yourself if you inject drugs: Do not inject drugs . If you do, use only sterile injection equipment and water, and never share your equipment with others.
• Protect yourself by taking PrEP: If you do not have HIV but are at risk of getting HIV, talk to your health care provider about  pre-exposure prophylaxis (PrEP) . PrEP involves taking a specific HIV medicine every day or an injectable HIV medicine every two months to reduce the risk of getting HIV through sex or injection drug use.
• Protect others if you have HIV: Take HIV medicine (called antiretroviral therapy or ART) as prescribed by your doctor. ART can reduce the amount of HIV in the blood (called viral load) to the point where a test cannot detect it (called an undetectable viral load). If you have an undetectable viral load, you will not transmit HIV to your partner through sex.
• Prevent perinatal transmission: If you have HIV and take HIV medicine as prescribed by your doctor throughout pregnancy and childbirth, the chances of transmitting HIV to your baby are less than 1%. If you have a partner with HIV and are considering getting pregnant, talk to your doctor about PrEP to help protect you and your baby from getting HIV while you try to get pregnant, during pregnancy, or while breastfeeding.

How is HIV transmitted?

The person-to-person spread of human immunodeficiency virus (HIV) is called HIV  transmission . People can get or transmit HIV only through specific activities, such as sex or injection drug use. HIV can be transmitted only in certain body fluids from a person who has HIV. Bodily fluids that can transmit HIV include blood, semen (“cum”), pre-seminal fluids (“pre-cum”), rectal fluids, vaginal fluids, and breast milk.

HIV transmission is only possible if these fluids come in contact with a mucous membrane, open cuts or sores, or are directly injected into the bloodstream (from a contaminated needle or syringe). Mucous membranes are found inside the rectum, the vagina, the opening of the penis, and the mouth.

In the United States, HIV is transmitted mainly by:

• Having anal or vaginal sex with someone who has HIV without using a  condom  or who is not taking medicines to prevent or treat HIV.
• Sharing injection drug equipment (“works”), such as needles or syringes, with someone who has HIV.

HIV can also be transmitted from a birthing parent with HIV to their child during pregnancy, childbirth (also called labor and delivery), or breastfeeding. This is called  perinatal transmission of HIV. Perinatal transmission of HIV is also called mother-to-child transmission of HIV.

How is HIV not transmitted?

You cannot get HIV from:

• Casual contact with a person who has HIV, such as a handshake, a hug, or a closed-mouth kiss (“social” kissing).
• Contact with objects, such as toilet seats, doorknobs, or dishes used by a person who has HIV.
• Mosquitoes, ticks, or other biting insects.
• Other sexual activities that do not involve the exchange of body fluids (for example, touching).
• Donating blood or receiving a blood transfusion.

Use the  You Can Safely Share…With Someone With HIV  infographic from HIVinfo to spread this message.

How can I reduce the risk of getting HIV?

Anyone can get HIV, but you can take steps to protect yourself from HIV.

• Get tested for HIV.  Talk to your partner about HIV testing and get tested before you have sex. Use the GetTested locator from the Centers for Disease Control and Prevention (CDC) to find an HIV testing location near you.
• Choose less risky sexual behaviors.  HIV is mainly transmitted by having anal or vaginal sex without a condom or without taking medicines to prevent or treat HIV.
• Use condoms every time you have sex.  Read this fact sheet from CDC on  how to use condoms correctly .
• Limit your number of sexual partners.  The more partners you have, the more likely you are to have a partner with poorly controlled HIV or to have a partner with a  sexually transmitted infection (STI) . Both factors can increase the risk of HIV transmission.
• Get tested and treated for STDs.  Insist that your partners get tested and treated, too. Having an STD can increase your risk of getting HIV or transmitting it to others.
• Talk to your health care provider about pre-exposure prophylaxis (PrEP).  PrEP is an HIV prevention option for people who do not have HIV but who are at risk of getting HIV (for example, if your partner has HIV or if you inject drugs). PrEP involves taking a specific HIV medicine to reduce the risk of getting HIV through sex or injection drug use. PrEP medications can be given in the form of pills (taken daily) or injections (every other month). It is important to take PrEP as directed by your doctor to effectively protect you against HIV. For more information, read the HIVinfo fact sheet on Pre-Exposure Prophylaxis (PrEP) .
• Do not inject drugs.  But if you do, use only sterile drug injection equipment and water, and never share your equipment with others.

How can I prevent passing HIV to others if I have HIV?

Take HIV medicines as directed by your doctor. Treatment with HIV medicines (called  antiretroviral therapy or ART ) helps people with HIV live long, healthy lives. ART cannot cure HIV, but it can reduce the amount of HIV in the body (called the  viral load ). One of the main goals of ART is to reduce a person's viral load to an undetectable level.

An  undetectable viral load  means that the level of HIV in the blood is too low to be detected by a viral load test . People with HIV who maintain an undetectable viral load by taking ART consistently as prescribed have effectively no risk of transmitting HIV to an HIV-negative partner through sex.

Remember, taking HIV medicines does not prevent transmission of other STIs.

In addition to maintaining an undetectable viral load, here are some other steps you can take to make sure you prevent HIV transmission to others:

• Use condoms correctly every time you have sex.
• Talk to your partner about taking PrEP.
• If you inject drugs, do not share your needles, syringes, or other drug equipment with other people.

Are HIV medicines used at other times to prevent HIV transmission?

Yes, HIV medicines are also used for post-exposure prophylaxis (PEP) and to prevent perinatal transmission of HIV.

• Post-exposure prophylaxis (PEP)  PEP means taking HIV medicines within 72 hours after a possible exposure to HIV to prevent HIV infection. PEP should be used only in emergency situations. It is not meant for regular use by people who may be exposed to HIV frequently. For more information, read the HIVinfo fact sheet on  Post-Exposure Prophylaxis (PEP) .   
• Prevention of perinatal transmission of HIV  Pregnant people with HIV take HIV medicines for their own health and to prevent perinatal transmission of HIV (HIV can be passed from a person with HIV to their child during pregnancy, childbirth, or breastfeeding). After birth, babies born to people with HIV receive HIV medicine to protect them from infection with any HIV that may have passed from mother to child during childbirth. For more information, read the HIVinfo fact sheet on  Preventing Perinatal Transmission of HIV .

This fact sheet is based on information from the following sources:

• How HIV Spreads
• Preventing HIV
• Preventing HIV With PrEP
• Preventing HIV With PEP

From the NIH Office of AIDS Research:

• Antepartum Care for Individuals With HIV:  Overview  
• Management of Infants Born to People with HIV Infection:  Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection

Also see the  HIV Source  collection of HIV links and resources.

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HIV Risk and Prevention

In the United States, HIV is mainly spread by having sex or sharing syringes and other injection equipment with someone who is infected with HIV. Substance use can contribute to these risks indirectly because alcohol and other drugs can lower people’s inhibitions and make them less likely to use condoms. This section provides information on the various risk behaviors and various prevention methods that can be utilized to reduce the risk of transmitting HIV.

• Injection Drug Use
• HIV Risk and Prevention Estimates
• Pre-Exposure Prophylaxis (PrEP)
• Post-Exposure Prophylaxis (PEP)
• HIV Treatment as Prevention
• Male Circumcision
• HIV Nexus: Resources for Clinicians
• Ending the HIV Epidemic (EHE)
• Public Health Partners
• Let’s Stop HIV Together
• @StopHIVTogether
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BMC Public Health, 2018

Globally renal diseases and especially renal failure has become a major public health issue. Also, there has been a steady increase in its incidence and prevalence, particularly in the developing countries, which are generally linked to risky lifestyles or unhealthy behaviours, especially amongst the young and marginalised groups in society. One of such marginalised groups is commercial sex workers (CSWs). However, attention on CSWs has generally been placed on their susceptibility to communicable diseases, with little attention on the non-communicable ones, like renal diseases. Such relatively low concern has been an added health burden on such societies. But do this marginalised group really understand their stand in relation to renal diseases in the context of their working conditions? Do they really perceive their lifestyle as predisposing factor to renal diseases? This paper, therefore, examined the attitude and perception of CSWs to their susceptibility to hazards of renal diseases in the context of their professional activities. Specifically, the study investigated the health-seeking behaviour of CSWs in relation to perceived susceptibility to renal diseases, the plausible denial of the linkage between their work, and their susceptibility to the disease. Guided by Health Belief Model, the study adopted the case study approach. Data collection was mainly qualitative with the use of in-depth interview with CSWs. Also, key informant interview was conducted with health professional. A pre-tested guide was used as instrument of data collection. The data were content analysed. The study found a low level of awareness of the linkage between the lifestyle of CSWs and renal health challenges, and a high degree of denial of susceptibility to renal health challenges. This, no doubt, has serious health implications, especially in the area of interventions amongst this, though marginalised, yet a significant population of the informal work group in Nigeria. Key words: Commercial sex workers, Health-seeking behaviour, Perceived susceptibility, Renal risks Word Count: 296

Women are one of the fastest growing groups infected with the human immunodeficiency virus (HIV), and the disease is becoming increasingly common among young women. This paper attempts to focus on the gender dimension of HIV/AIDS in global perspective. In doing so, special attention will be given on the vulnerability of women to HIV/AIDS in Bangladesh. The vulnerability of male and female are influenced by societal factors such as gender roles, socioeconomic environment, class differences, and prevalent ideology including cultural norms, values and attitudes. Due to the biological differences as well as sole and position in the society, the nature and range of suffering is also different for men and women. The picture is more evident where the male dominates the society. Available data substantiates that pervasive poverty and unemployment, frequent natural disasters, high mobility and migration, low socioeconomic status of women and their trafficking, commercial blood donation and high prevalence of STIs has made women of Bangladesh vulnerable to HIV/AIDS.

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Institute of Medicine (US) Committee to Study HIV Transmission Through Blood and Blood Products; Leveton LB, Sox HC Jr., Stoto MA, editors. HIV And The Blood Supply: An Analysis Of Crisis Decisionmaking. Washington (DC): National Academies Press (US); 1995.

HIV And The Blood Supply: An Analysis Of Crisis Decisionmaking.

• Hardcopy Version at National Academies Press

8 Conclusions and Recommendations

The HIV epidemic has taught scientists, clinicians, public health officials, and the public that new infectious agents can still emerge. The nation must be prepared to deal with a fatal illness whose cause is initially unknown but whose epidemiology suggests it is an infectious disease. The AIDS epidemic has also taught us another powerful and tragic lesson: that the nation's blood supply—because it is derived from humans—is highly vulnerable to contamination with an infectious agent. A nation's blood supply is a unique, essential, life-giving resource. Whole blood and many blood products are lifesaving for many people. As a whole, our nation's system works effectively to supply the nation with necessary blood and blood products and its quality control mechanisms check most human safety threats. The events of the early 1980s, however, revealed an important weakness in the system—in its ability to deal with a new threat that was characterized by substantial uncertainty. The potential for recurring threats to the blood supply led this Committee to reappraise the processes, policies, and resources through which our society attempts to preserve its supply of safe blood and blood products.

• General Conclusions

The events and decisions that the Committee has analyzed underscore the difficulty of decisionmaking when the stakes are high, when decisionmakers may have personal or institutional biases, and when knowledge is imprecise and incomplete. The Committee attempted to understand the complexities of the decisionmaking process during the period analyzed in this report and develop lessons to protect the blood supply in the future. In retrospect, the system was not dealing well with contemporaneous blood safety issues such as hepatitis, and was not prepared to deal with the far greater challenge of AIDS.

By January 1983, the Centers for Disease Control (CDC) had accumulated enough epidemiological evidence to conclude that the agent causing AIDS was almost certainly transmitted through blood and blood products and could be sexually transmitted to sexual partners. The conclusion that the AIDS agent was blood-borne rested on two findings. First, AIDS was occurring in transfusion recipients and individuals with hemophilia who had received AHF concentrate; these AIDS patients did not belong to any other known high-risk group for contracting AIDS. Second, the epidemiologic pattern of AIDS was similar to hepatitis B, another blood-borne disease. However, the magnitude and consequences of the risk for transfusion and blood product recipients was not known at this time. Furthermore, the epidemiological pattern of the new disease was difficult to interpret because, unlike most infectious diseases, there seemed to be several years between exposure leading to infection and the development of symptoms. As a result, physicians and public health officials underestimated the large number of infectious people who had no symptoms of AIDS but could transmit the disease to others and therefore substantially understated the risk of infection.

Compared to the pace of many regulatory and public health decision processes, the federal government responded relatively swiftly to the early warnings that AIDS might be transmitted through blood and blood products. Public and private sector officials considered a range of clinical and public health interventions for reducing the risk of AIDS transmission through blood and blood products. This period, however, was characterized by a great deal of scientific uncertainty about the risks of HIV infection through blood and blood products and about the costs and benefits of the available options. The result, the Committee found, was a pattern of responses which, while not in conflict with the available scientific information, was very cautious and exposed the decisionmakers and their organizations to a minimum of criticism. This limited response can be seen in the refusal of blood banks in 1983 and 1984 to screen for and defer homosexuals or use surrogate tests ( Chapter 5 ), in the Food and Drug Administration's (FDA) cautious and inadequate regulatory approach to the recall of potentially contaminated AHF concentrate ( Chapter 6 ), and in the failure of physicians and the National Hemophilia Foundation to disclose completely the risks of using AHF concentrate and the alternatives to its use ( Chapter 7 ).

Blood safety is a shared responsibility of many diverse organizations. They include U.S. Public Health Service agencies such as the CDC, the FDA, and the National Institutes of Health (NIH), and private-sector organizations such as community blood banks and the American Red Cross, blood and plasma collection agencies, blood product manufacturers, groups such as the National Hemophilia Foundation (NHF), and others. The problems the Committee found were inadequate leadership and inadequate institutional decisionmaking processes in 1983 and 1984. No person or agency was able to coordinate all of the organizations sharing the public health responsibility for achieving a safe blood supply.

Decisionmaking Under Uncertainty

The management of a public health risk requires an evolving process of decisionmaking under uncertainty. It includes interpretive judgment in the presence of scientific uncertainty and disagreement about values. Public health officials must characterize and estimate the magnitude of the risk, which involves considering both the likelihood that infection might occur in various circumstances, and the costs and benefits associated with each of the possible uncertain outcomes. They must also develop and test public health and clinical care strategies, and communicate with the public about the risk and strategies for reducing it. When confronted with a poorly understood and anomalous public health threat, inertia often influences decisions. It is often easier to maintain the status quo than to make a change. In fact, regulatory policymakers, health scientists, and medical experts often require substantial scientific evidence before informing the public and adopting remedial action. Lack of scientific consensus becomes a kind of amplifier for the usual discord and conflict that can be expected whenever an important science-based public policy decision—one profoundly affecting lives and economic interests—must be made. First, uncertainty creates opportunities for advocates of self-interested and ideological viewpoints to advance plausible arguments that favor their desired outcome. Second, uncertainty intensifies bureaucrat cautiousness.

In the course of its investigations, the Committee learned several lessons about decisionmaking under uncertainty. These are set out here both as general lessons and to provide a framework for the recommendations that follow.

Risk Perception

Risk perception is shaped by social tensions, and cultural, political, and economic biases (Douglas 1985). It is important to understand the different contexts in which risk is perceived and the complex system of beliefs, values, and ideals that shape risk perception (Nelkin 1989). There are several other factors that influence risk perception, including locus of control, the type of risk posed by the threat, and the time interval involved in evaluating the risk. For example, people tend to underestimate risks that they perceive to be under their control, risks associated with a familiar situation, and low probability events (Douglas 1985). People have difficulty accepting estimates of a risk that is involuntary, uncertain, unfamiliar, and potentially catastrophic (Fischoff 1987). The epidemic caused by HIV in the blood supply illustrates these patterns of perception and behavior with respect to risk.

Risk Assessment Versus Risk Management

A central precept of risk management is to separate the assessment of risk from the management of its consequences (NRC 1983). Otherwise, risk managers tend to bias their estimates of the magnitude of the risk in favor of their preconceived notions about appropriate or desirable policy choices. The events that the Committee studied provide examples of what can happen when this precept is not followed. When there is uncertainty, it may be necessary to assess risk by making subjective estimates rather than by obtaining objective measures. Such was the case in 1983 when, as part of implicit risk-benefit calculations about donor screening and deferral, blood banks and blood product manufacturers had to make judgments about the risk that their products could transmit AIDS (see Chapter 5 ). Anticipating the consequences of taking action, which is in the domain of risk management, may bias risk estimates toward values that support risk-averse action. When blood bank officials estimated the risk of transmitting AIDS as ''one per million" transfusions, they chose a rate that was low enough to justify their reluctance to take further action. Despite mounting evidence that the risk was much higher, they maintained their original estimate throughout 1983. If the CDC had made numeric estimates of the risk, and the blood banks, blood product manufacturers, or the FDA had used these estimates in a formal analysis of the decision problem, they might have reached different conclusions about, for example, surrogate testing for AIDS.

Consider the Full Range of Possibilities

When there is uncertainty about the facts that will determine the consequences of a decision, a systematic approach is usually best (NRC 1994). One important principle is to consider the full range of assumptions and alternative actions, not only worst-case scenarios. In the events studied by the Committee, systematic denial of worst-case scenarios was a recurring theme, as can be seen in the way that the NHF and the FDA discussed the CDC's warnings in 1982 and early 1983. The plasma fractionators introduced a worst case scenario of their own at the July 1983 Blood Products Advisory Committee (BPAC) meeting, when they estimated that three or four suspect donors and an automatic recall policy could lead to recall of all of the nation's supply of AHF concentrate ( Chapter 6 ). A closely related principle is to scrutinize the evidence to ascertain what is based on fact, what is a "best-guess" estimate, and what is simply untested conventional wisdom.

One approach to such an analysis would be to use a formal group process to systematically sample expert opinion on relevant factors such as the probability of infection and the economic and noneconomic costs and benefits of each of the possible outcomes. Often these officials should use decision analysis, which takes into account the likelihood of events and the magnitude of their outcomes, as a tool to compare the expected value of the outcome of the policy alternatives under consideration. Two somewhat analogous models to consider include those used in Institute of Medicine studies to establish priorities for the development of new vaccines (IOM 1985) and to evaluate the artificial heart program of the National Heart, Lung, and Blood Institute (IOM 1991). The book Acceptable Risk (Fischoff, et al. 1981) also offers sensible approaches to dealing with this kind of situation.

Risk Reduction Versus Zero Risk

Decisionmakers tend to seek zero-risk solutions even when they are unattainable or unrealistically costly (NRC 1994). In doing so, they may run the risk of failing to implement solutions that are less effective but are certain to reduce illness. The failure to adopt risk-reduction strategies can be seen in the resistance of blood banks to screening for homosexual activity or using surrogate tests for AIDS ( Chapter 5 ) and in FDA's limited approach to product recall decisions ( Chapter 6 ). Chapter 7 also points out that many risk-reduction strategies for individuals with hemophilia were available but not fully disclosed or recommended. The perfect should not be the enemy of the good.

Risk Communication

Risk communication is a sensitive area because of its influence on the perceptions and behaviors of health professionals and consumers, regulatory policies, and public decisionmaking (Nelkin 1989). Many public health officials and physicians wish to appear in command and infallible. When uncertain, they remain silent rather than disclose their ambivalence (NRC 1989). In the Committee's view, however, the greater the uncertainty, the greater the need for communication. The Committee's analysis of physician–patient communications at the beginning of the AIDS era illustrates the tragedies that can accompany silence about risks ( Chapter 7 ). Risk-communication skills are equally important when presenting information to the general public. The blood banks' reluctance to acknowledge the risk of transfusion-associated AIDS ( Chapter 5 ) seems to have been due in part to the difficulties that they foresaw in presenting this information to potential donors and recipients.

Other important principles of risk communication are that the source of the information must be credible, the process should be open and two-way, and the message should be balanced and accurate (NRC 1989). When there was no other sources of information for physicians treating people with hemophilia and for their patients, the NHF and its Medical and Scientific Advisory Council (MASAC) took on an important risk-communication role—providing what would now be called "clinical practice guidelines." The NHF's credibility in this area was eventually seriously compromised by its financial connections to the plasma fractionation industry.

Bureaucratic Management of Potential Crises

Federal agencies had the primary responsibility for dealing with the national emergency posed by the AIDS epidemic. The Committee scrutinized bureaucratic function closely, and came to the following conclusions about the management of potential crises.

Coordination and Leadership

A crisis calls for extraordinary leadership. Legal and competitive concerns may inhibit effective action by agencies of the federal government. Similarly, when policymaking occurs against a backdrop of a great deal of scientific uncertainty, bureaucratic standard operating procedures designed for routine circumstances seem to take over unless there is a clear-cut decisionmaking hierarchy. An effective leader will insist upon coordinated planning and execution. Focusing efforts and responsibilities, setting timetables and agendas, and assuming accountability for expeditious action cannot be left to ordinary standard operating procedures. These actions are the responsibilities of the highest levels of the public health establishment.

The Public Health Service failed to bring these leadership functions to bear when CDC scientists raised concerns about the blood supply at the January 4, 1983 meeting but received no public support from the director of the CDC or the office of the Assistant Secretary for Health. Similarly, the record does not indicate that the highest levels of the FDA or the PHS were involved in responding to advice from the BPAC regarding donor deferral or product recall. Part of this leadership problem may stem from major changes in the PHS leadership that took place during this period: the leadership of the FDA, the CDC, and the NIH, and the person serving as the Assistant Secretary for Health all changed between 1982 and 1984.

Advisory Mechanisms

In the early 1980s, the FDA and other agencies did not have a systematic approach to conducting advisory committee proceedings. Such an approach requires that agencies tell their advisory committees what is expected of them, keep attention focused on high-priority topics, and independently evaluate the advice offered. No regulatory process should have its information base effectively controlled by an advisory panel. Public agencies must be able to generate and analyze the information that they need to assure that decisions serve the needs of the public. The FDA failed to observe this principle when it allowed statements and recommendations of the BPAC to go unchallenged, apparently because it could not independently analyze the information ( Chapter 6 ).

Because mistakes will always be made and opportunities sometimes missed, regulatory structures must be organized and managed to assure both the reality and the continuous appearance of propriety. The prominence of representatives from blood banks and blood product manufacturers on the BPAC, with no balancing influence from consumers and no process within the FDA to evaluate its recommendations ( Chapter 6 ), is a failure of advisory committee management. Perhaps advisory committees should contain fewer topical experts and more members with expertise in principles of good decisionmaking and the evaluation of evidence. A committee so constituted might run a reduced risk of standing accused of having conflicts of interest.

Analytic Capability and Long-Range Vision

Leadership passes to the organization that has access to information and the ability to analyze it. Federal agencies should avoid exclusive reliance upon the entities which they regulate for analysis of data and modeling of decision problems. The FDA should have had some independent capacity to analyze the information presented at the July 1983 BPAC meeting that suggested that with only three or four suspect donors, an automatic recall policy would completely deplete the nation's supply of AHF concentrate ( Chapter 6 ). In addition, there did not seem to be any focus within the Public Health Service prepared to, or charged to, analyze the options, costs, and benefits of the options for protecting the blood supply that were discussed at the January 4, 1983, meeting convened by CDC.

In addition, agencies need to monitor more systematically the long-term outcomes of blood transfusion and blood product infusion and to think far ahead to anticipate both new technologies and new threats to the safety of the blood supply. Because new pathogens can enter the blood supply and be propagated very rapidly through it, a low level of suspicion about a threat should trigger high-level consideration of how to manage and monitor the problem.

Through its fact-finding interviews and through written documents, the Committee found little evidence that the PHS agency heads and the Assistant Secretary for Health were involved in making decisions about protecting the blood supply in 1983 and 1984 when HIV was becoming increasing apparent as a threat. Most decisions and interagency communication seems to have occurred several levels below the top.

Presumptive Regulatory and Public Health Triggers

The Committee believes that the Public Health Service should prepare for future threats to the blood supply by specifying in advance the types of actions that should occur once the level of concern passes a threshold. In the face of scientific uncertainty, the PHS needs a series of criteria or triggers for taking regulatory or other public health actions to protect the safety of blood and blood products. The Committee favors a series of triggers in which the response is proportional to the magnitude of the risk and the quality of the information on which the risk estimate is based. Not all triggers should lead to drastic or irrevocable actions; some merely require careful consideration of the options or developing new information. This general principle is detailed by examples in each of the Committee's four areas of inquiry. Table 8.1 summarizes these triggers and corresponding actions.

Triggers for Taking Actions in Response to Uncertain.

Product Treatment

Whenever they propose new methods of protecting the safety of the blood supply, blood regulatory agencies must perform cost-utility or cost-benefit analyses to evaluate whether the intervention will advance the public health at reasonable costs. If manufacturers do not have market incentives, resources, or access to data to test promising methods, public agencies should create incentives or provide resources or access to data. In this case, the trigger is a new proposal to increase safety, and the action is for the public sector to assume responsibility for thorough analysis and development, or to create incentives for industry to do so.

When performing a cost-effectiveness analysis of new treatments for blood products, the potential to protect against other threats should always be a part of the analysis. Here, the trigger is the initiation of a cost-effectiveness analysis, and the action is to ensure that the analysis takes into account secondary benefits.

Donor Screening

Whenever epidemiologists identify a high-risk donor group, the FDA should immediately tell blood banks to create a way to defer that group and tell collection agencies to segregate and separately treat supplies obtained from those populations. Concerns about stigmatizing subpopulations and maintaining the supply of blood products should influence the means of taking actions, not whether to take action. In this case, the trigger to action is the identification of a high-risk population, and the action is deferral and segregation of lots.

Whenever any segment of the industry institutes a donor screening program, the FDA should require all segments of the industry to follow suit with actions that they believe will be at least as effective in promoting safety. Public regulators have a responsibility to monitor these efforts and to forge consensus or to impose the most effective methods as information concerning efficacy becomes available. Here, the trigger is one company's action to take an additional safety measure, and the response is for all companies to follow suit, or to be held accountable when they do not.

Blood banks should use a partially effective intervention that has little or no risk unless they can show that a better method will rapidly supersede it. In this case the trigger is the availability of an inherently risk-free, partially effective intervention, and the response to use that test/intervention unless it is certain to become redundant prior to realizing its full benefits.

When a test or treatment makes a product safer, manufacturers should withdraw all stocks of untested or untreated product as quickly as possible. Where immediate complete withdrawal might injure the public health, withdrawals should be partial or staged. Here, the trigger is the implementation of a new test or treatment process, and the action is to recall untested or untreated products as expeditiously as possible, given other considerations of public health.

A limited, staged, or selective recall places responsibility on public regulatory agencies to establish criteria for selecting lots for recall, to provide processes to permit effective implementation of the recall by industry, and to monitor the recall to assure that removal of the products occurs in the prescribed manner. In this case the trigger is the initiation of a recall action, and the response is to provide clear guidance and monitoring.

Communication to Patients and Providers

Whenever new information triggers inquiry into a possible threat to the blood supply, both patients and their physicians should have access to the information. Public officials should presume that candid statements and rigorous actions will enhance rather than erode public confidence and that persons using blood or blood products have the right to understand fully the risks and benefits of using these products. In this case, the trigger is new information relevant to the public health, and the action is to tell affected individuals what they need to make an informed choice: the facts, the gaps in knowledge, and the implications thereof.

• Recommendations

The Committee's charge was to learn from the events of the early 1980s the lessons that would help the nation prepare for future threats to the blood supply. The Committee identified potential problems with the system in place at that time (as summarized earlier in this chapter) and proposes changes that, if implemented in the early 1980s, might have moderated some of the effects of the AIDS epidemic on recipients of blood and blood products. This analysis has led the Committee to the following recommendations for Public Health Service agencies, for the blood and plasma fractionation industry, and for health care providers and the public. These recommendations address both public health options and individual clinical options.

The Committee is mindful of several caveats. First, the Committee is acutely aware of the difficulties of retrospective analysis, as described in Chapter 1 . Second, the Committee has not considered its recommendations from perspectives other than blood safety. Finally, the Committee tried to identify opportunities for institutional change that would respond to the problems that the Committee diagnosed. The Committee based its recommendations on the institutions as they functioned in the early 1980s, not as they exist now. The organizations responsible for blood safety and public health will have to evaluate their current policies and procedures to see if they fully address the issues raised by our recommendations.

The Public Health Service

Several federal agencies necessarily play important, often different roles in managing a public health crisis such as the contamination of blood and blood products by the AIDS virus. The National Blood Policy of 1973 charged the Public Health Service (including the CDC, the FDA, and the NIH) with responsibility for protecting the nation's blood supply.

The Committee has come to believe that a failure of leadership contributed to delay in taking effective action, at least during the period from 1982 to 1984. This failure led to incomplete donor screening policies, weak regulatory actions, and insufficient communication to patients about the risks of AIDS.

In the event of a threat to the blood supply, the PHS must, as in any public health crisis, insist upon coordinated action. The Secretary of Health and Human Services is responsible for all the agencies of the Public Health Service, 1 and therefore the Committee makes

Recommendation 1: The Secretary of Health and Human Services should designate a Blood Safety Director, at the level of a deputy assistant secretary or higher, to be responsible for the federal government's efforts to maintain the safety of the nation's blood supply.

Choosing a "lead person" is important because it is in the nature of federal agencies and their leaders to be at once competitive and protective. This condition is healthy in reasonable measure and in normal times. However, a serious threat to public health requires that agencies communicate, cooperate, and learn to view the world through each other's lenses. Once there is an action plan, the Secretary of Health and Human Services must hold the agency leaders accountable for enforcing cooperation in implementing the plan.

To be effective in coordinating the various agencies of the PHS, the Blood Safety Director should be at the level of a deputy assistant secretary or higher, and should not be a representative of any single PHS agency. When a threat does arise, the Blood Safety Director should create a crisis management team.

One such action was to establish, in July 1982, the Committee on Opportunistic Infections in Hemophiliacs (see Chapter 3 ). This group seems to have been organized by the CDC, but there is no record of its operations after August of that year.

Blood Safety Council

The AIDS crisis revealed that the institutions in place to ensure blood safety, both public and private, were unable to work cooperatively toward a common goal of a safe blood supply. The institutions were not accountable to anyone but themselves, and they failed to cooperate, to coordinate their activities, and to communicate effectively with physicians and the public. The Committee has become convinced that the nation needs a far more responsive and integrated process to detect, evaluate, and respond to emerging threats to the blood supply. To this end the Committee makes

Recommendation 2: The PHS should establish a Blood Safety Council to assess current and potential future threats to the blood supply, to propose strategies for overcoming these threats, to evaluate the response of the PHS to these proposals, and to monitor the implementation of these strategies. The Council should report to the Blood Safety Director (see Recommendation 1). The Council should also serve to alert scientists about the needs and opportunities for research to maximize the safety of blood and blood products. The Blood Safety Council should take the lead to ensure the education of public health officials, clinicians, and the public about the nature of threats to our nation's blood supply and the public health strategies for dealing with these threats.

Supplying safe blood and blood products to the nation—a public good—requires the cooperation of public and private institutions. The Blood Safety Council would give voice to the public's interest in having these institutions cooperate and would provide opportunities for them to do so.

The lessons of HIV transmission through blood and blood products show the need for an advisory council with a significantly greater level of diversity, responsibility, and authority than the current Blood Products Advisory Committee of the FDA. The BPAC is limited by the regulatory mission of the FDA which it advises, and there is no other body primarily concerned with blood safety as a whole. Representatives from governmental agencies, academia, the blood bank community, industry, and the public all have relevant expertise and perspectives and should be involved in the Blood Safety Council. A broad-based range of expertise in areas of hematology, infectious diseases, epidemiology, blood product manufacturing, blood collection and delivery, risk assessment, consumer advocacy, and cost-benefit analysis is essential.

The proposed Blood Safety Council would facilitate the timely transmission of information, assessment of risk, and initiation of appropriate action both during times of stability and during a crisis. The Council should report to the Blood Safety Director (see Recommendation 1). The Council would not replace the PHS agencies responsible for blood safety but would complement them by providing a forum for them to work together and with private organizations. The PHS agencies would be represented on the Council (see below and Figure 8.1 ). The Council would not have its own surveillance capability, but would work with CDC and FDA to interpret the information that those organizations can provide. It would not carry out or fund research itself, but would work with those at NIH and in the private sector to identify priorities for blood safety research. The Council would not have regulatory power, but would inform FDA actions from a blood safety rather than a product-specific perspective.

Figure 8.1.

Blood Safety Council relationships.

The organizations and groups that should be included in the Blood Safety Council, and the reasons for including them, are as follows:

• The FDA can provide a direct link between itself, the essential regulatory agency responsible for the safety of blood and blood products, and important sources of information, scientific support, and disease surveillance findings.
• The CDC can provide expertise in epidemiology, infectious diseases, and immunology as well as communicate the results of ongoing disease surveillance studies. The CDC's newly established emerging infectious disease program would also provide valuable information.
• The NIH can provide scientific expertise and the means to communicate information about essential research needs to the appropriate institutes for support of research.
• Representatives from academia can bring independent scientific and medical expertise, especially in hematology, infectious diseases, epidemiology, risk assessment, and cost-effectiveness analysis.
• Representatives from the volunteer blood collection community can bring experience with blood safety concerns and the knowledge of blood bank operations that is necessary to evaluate proposed change.
• Representatives from the private-sector blood product manufacturers and biotechnology companies can bring both experience with blood safety concerns and knowledge of plasma fractionation operations.
• Representatives of the general public (who may in the future require blood transfusions) and individuals who currently require frequent use of blood products, such as hemophilia patients, bring important perspectives on the trade-offs that must be considered in evaluating response options.

The Blood Safety Council should consider the following activities and issues:

Surveillance. Although the FDA and the CDC keep track of events in blood and blood product recipients, their surveillance systems are passive and incomplete. The Blood Safety Council should work with the CDC to design a system of active surveillance for adverse reactions in blood recipients, as described in Recommendation 5 below. If such a system is established, the Council would benefit from its results and should participate in its governance.

Expert Panel on Best Practices . Drawing on its members' knowledge about blood and blood product safety concerns, and about clinical alternatives, the Blood Safety Council could establish a panel of experts to provide the public and providers of care with information about risks and benefits, alternatives to using blood products, and recommended best practices, as described in more detail in Recommendation 13 below.

Investigate Methods to Make Blood Products Safer. The Council should evaluate new methods to make blood and blood products safer. One promising approach is double inactivation in the preparation of blood products, which minimizes the risk of transmission of infectious pathogens in the blood of the donor pool. At present, the FDA requires only a single inactivation process (usually solvent detergent or heat treatment) for most blood products manufactured in the United States. With the goal of maximizing the safety of the blood supply at minimal added cost, the Blood Safety Council should encourage the FDA to evaluate double inactivation methods and expeditiously relicense products manufactured by the improved technologies, if appropriate. The Blood Safety Council should also consider, at least yearly, in a public forum, opportunities to maximize the safety of the blood supply.

Another promising approach is to reconsider minimum pool size requirements in plasma product manufacturing. The FDA currently requires a large number of donors to be included in plasma pools used in the manufacture of plasma products in order to ensure a wide range of antibodies in preparations of intravenous gamma globulin. Pooling of plasma obtained from numerous donors, although permitting some economy of scale, also increases the risk that a large fraction of manufactured blood products will be contaminated by a single infected donor. The Blood Safety Council should consider this issue and address the safety and efficiency trade-offs in changing the minimum pool size.

The Blood Safety Council would provide information relevant to the decisions that individuals as well as public and private decisionmakers need to make. The forum would not have direct regulatory or other authority, but would function as a forum for holding the organizations with authority responsible for blood safety. In short, the Blood Safety Council could advocate the public's need for a responsible process for decisionmaking about public health policy. The following examples illustrate how regular public discussions of blood safety issues, in the presence of representatives from the relevant organizations' perspectives, could provide an opportunity to hold the organizations with authority accountable for blood safety.

If it had existed in the 1970s, for instance, the Blood Safety Council might have called for the development of heat-treated AHF concentrate to reduce the risk of hepatitis, which would have also reduced the risk of HIV transmission. It would have been able to do so if the NIH and blood products industry representatives on the Council had been called upon to make periodic reports to the Council during the 1970s about their efforts to deal with the hepatitis problem. These representatives would have fed the discussions of the Council back into their own organizations' decisionmaking.

In 1983, the Council could have provided a forum for CDC to present its concerns about HIV in the blood supply and held the FDA, the NHF, and the blood banks and fractionators accountable for responding constructively. CDC created a forum on its own by convening the January 4, 1983, meeting in Atlanta, but as the Committee's analysis indicates, the follow-up on this meeting was insufficient. If a standing Blood Safety Council had existed, the CDC scientists who had concerns about the safety of blood and blood products would have had an opportunity to hold blood collection organizations accountable for their decisions regarding donor deferral and surrogate testing. It would also provide an opportunity to hold plasma fractionators and the FDA accountable for its decisions with regard to heat-treated AHF.

Later that year, the Council could have provided a mechanism to evaluate the claims that automatic recall of AHF would have virtually eliminated the supply of AHF. As the analysis in Chapter 6 indicates, neither the BPAC nor the FDA staff had the capacity to analyze claims that a automatic recall would have such an effect. The Blood Safety Council could have insisted that the FDA commission a formal decision analysis of the options for surrogate testing, or the Council might have performed such an analysis itself. The FDA would retain its regulatory authority, and continue to get advice from the BPAC, but the Council would have provided critical information relevant to the agency's decision.

Finally, if the Council had established an expert panel on best practices as described above and in Recommendation 13, hemophilia patients and their physicians would have had a more credible source of information about the risks of HIV infection and their clinical options than the NHF was able to provide. The operations of such a panel are described below under Recommendation 13.

Compensation Policy

When a product or service provided for the public good has inherent risks, the common law tort system fails to protect the rightful interests of patients who suffer harm resulting from the use of those products or services. Each claim requires extended, costly, and complex adjudicative procedures to establish liability. The results are erratic and unpredictable, and therefore inequitable (IOM 1985).

The doctrine of strict liability holds manufacturers accountable for injuries that are incurred from products that are inherently dangerous because diligence cannot fully eliminate their risks. The public health imperative of assuring enough vaccine for widespread use argues for limits on the strict liability doctrine for vaccine-related injuries. The chief concern is that fear of liability will discourage manufacturers from producing a vital public good. To vitate this concern, a federal compensation system has removed vaccine-related injuries from the scope of strict liability laws (Mariner 1992). The federal government established a mechanism for compensating individuals suffering harm from vaccine-related complications. Its rationale is that consent to undergo vaccination confers benefits to the entire community.

Blood-product-related injuries have also been removed from the scope of strict liability law by blood shield laws, which are in force in most states, and which protect society's interests in having an adequate blood supply. The blood shield laws serve to protect providers and manufacturers of blood and blood products from liability claims in instances where they take all due care to ensure the safety of the product. These laws, however, are unique in the manner in which they limit liability. The shield laws have made it difficult, and often impossible, to obtain compensation for HIV infection acquired from blood or blood products. To address this asymmetry between the protection that blood shield laws offer for manufacturers and adequate protection of individual rights, the Committee makes

Recommendation 3: The federal government should consider establishing a no-fault compensation system for individuals who suffer adverse consequences from the use of blood or blood products. 2

An effective no-fault system requires prospective standards and procedures to guide its operations. In a no-fault system, individual plaintiffs would not have to prove that their adverse outcome was a result of negligence related to manufacture of a blood product. Therefore, there needs to be an objective, science-based process to establish which categories of adverse outcomes are caused by blood-borne pathogens and which individual cases deserve compensation. As with vaccines, a tax or fee paid by all manufacturers or by the recipients of blood products could finance a compensation system. Rather than attempt to allocate blame for HIV infections through blood and blood products, some countries have established such no-fault compensation programs for individuals infected with HIV as a result of their use of blood and blood products. Countries fund these programs in a variety of ways, including direct government support and joint public/private resources.

Making recommendations about compensating affected individuals for damages incurred in the past is outside the Committee's mandate. However, had there been a no-fault compensation system in the early 1980s, it could have relieved much financial hardship suffered by many who became infected with HIV through blood and blood products in the United States. The no-fault principles outlined in this recommendation might serve to guide policymakers as they consider whether to implement a compensation system for those infected in the 1980s.

The Centers for Disease Control and Prevention

The CDC has an indispensable role to play in protecting our nation's health: to detect potential public health risks and sound the alert. Because of its expertise in detecting and evaluating possible infectious disease outbreaks, the Committee believes that the CDC should take responsibility for a surveillance system to detect adverse outcomes from blood and blood products. The following two recommendations embody an important principle: separating the assessment of risk from the management of the consequences of risk. The FDA, in its role as guarantor of the safety of the blood supply, has the responsibility for managing threats to the blood supply. The CDC should detect potential threats and assess the magnitude of the danger.

Early Warning Systems

A nation needs individuals and organizations that identify problems and raise concerns that may be difficult to confront. The CDC plays this role in the Public Health Service. The CDC appears to have been prescient in raising the possibility that the blood supply was contaminated early in the AIDS epidemic, but it was relatively ineffective in convincing other agencies of the potential gravity of the situation. In order to improve CDC's efficacy in this critical role, the Committee makes

Recommendation 4: Other federal agencies must understand, support, and respond to the CDC's responsibility to serve as the nation's early warning system for threats to the health of the public.

Officials in the government, scientists, and physicians in the private sector seem to have discounted the CDC warnings about the transmissibility of AIDS through blood and blood products because the swine flu episode in the 1970s had cost the agency considerable credibility. If, in 1983, the involved public and private organizations had the attitude called for in this recommendation, CDC's recommendations regarding donor screening and surrogate testing might have led to earlier, more effective screening and donor deferral policies.

Consistent with the precept of separating risk assessment and risk management as described above, CDC's role is to characterize and assess risks, and communicate this to others. The FDA and other organizations have the responsibility to manage the risks through regulation, clinical practice guidelines, and other means. The Committee believes that CDC should be able to play its designated role without fearing loss of credibility if it sometimes proves to be wrong. Implementing this recommendation may be difficult. As a start, the Secretary of Health and Human Services should insist that an agency that wishes to disregard a CDC alert should support its position with evidence that meets the same standard as that used by the CDC in raising the alert.

Surveillance

In order to carry out its early warning responsibility effectively, the CDC needs good surveillance systems. Because blood products are derived from human beings and may contain harmful biologic agents that were present in the blood of a donor, blood products are inherently risky, a principle long recognized by blood shield laws. The Committee, believing that the degree of surveillance should be proportional to the level of risk, makes

Recommendation 5: The PHS should establish a surveillance system, lodged in the CDC, that will detect, monitor, and warn of adverse effects in the recipients of blood and blood products.

If such a system had existed in 1982, data about the risks of HIV transmission through blood and blood products might have been available sooner and might have been more definitive. In dealing with newly approved pharmaceuticals, the FDA increasingly demands careful post-approval study of potential adverse effects (the so-called ''Phase IV Trial"). Two existing systems for vaccine adverse events—the CDC/FDA Vaccine Adverse Event Reporting System (VAERS) and the CDC's Large-Linked Database (LLDB)—might be useful models (Institute of Medicine 1994).

The Food and Drug Administration

The FDA has legal authority to protect the safety of the nation's blood supply. Accordingly, it is the lead federal agency in regulating blood-banking practice, the handling of source plasma, and the manufacture of blood products from plasma. The Committee found cause for concern when it evaluated the FDA's actions in protecting the public from HIV in the nation's blood supply during the 1980s. The record reveals many opportunities to improve the agency's capacity to deal with crises involving the blood supply, most notably with respect to the safety of AHF concentrate. In responding to these opportunities, the Committee's recommendations focus on decisionmaking and the role of advisory committees in formulating the FDA's response to crises.

Risk Reduction

In a crisis, decisionmakers may become so preoccupied with seeking solutions that will dramatically reduce danger that they will fail to implement solutions that are less effective but are likely to improve public safety to some degree. Partially effective risk-reducing improvements, as described herein, can save lives, pending the development of more efficacious safety measures. In order that the perfect not be the enemy of the good, the Committee makes

Recommendation 6: Where uncertainties or countervailing public health concerns preclude completely eliminating potential risks, the FDA should encourage, and where necessary require, the blood industry to implement partial solutions that have little risk of causing harm.

In the event of a future threat to the blood supply, the FDA should encourage small, low-risk solutions to large, difficult problems. The FDA's actions during the early 1980s are evidence that the agency should change its attitude toward regulation in order to adopt this proactive approach. Some examples from Chapter 6 illustrate how the FDA might have encouraged practices that would have reduced the risk faced by recipients of blood or a blood product.

Example: Destroy Unscreened Blood When Possible . When hospital blood banks first started to screen donors by questioning them for risk factors, there was a period of transition during which its stocks contained two classes of blood or plasma: blood from screened donors, which was relatively safe; and blood from unscreened donors, which had a higher probability of containing HIV. Within a few weeks of starting to screen donors, blood from unscreened donors would have been either used or discarded. In the instructions contained in its letter of March 24, 1983, the FDA could have recommended that blood banks adopt a policy of using blood from screened donors whenever possible during the transition period, a policy that some blood banks may have adopted on their own. Requiring all blood banks to adopt this policy would not have compromised the nation's blood supply, and it would have prevented at least a few instances in which a patient received an infected unit of blood.

Example: Destruction of Potentially Contaminated Cryoprecipitate. Blood banks store cryoprecipitate from a single unit of donated blood in the frozen state for up to one year. The FDA could have issued a directive that required the blood banks to check their inventory of frozen cryoprecipitate and destroy possibly contaminated units whenever they learned of a previous donor who had AIDS or was strongly suspected of having AIDS.

Example: Phased Recall. In July 1983, there was considerable reluctance to recall untreated Factor VIII concentrate at a time when much of the supply was almost certainly contaminated with HIV. The FDA apparently feared that the ensuing shortage of Factor VIII would have caused more harm than the HIV virus. A phased withdrawal would have been a compromise between no withdrawal and immediate total withdrawal. This middle path might have avoided a factor concentrate shortage and still reduced the number of hemophiliacs who became infected.

Example: Lookback. The FDA formally instituted a "lookback" policy in 1991, years after it was clear that AIDS had a long incubation period during which a patient could transmit HIV through sexual contact or contact with blood. Lookback required blood banks to contact recipients of blood from infected donors and notify them that they might be a HIV carrier and should be tested for HIV antibodies. Earlier action on lookback might have reduced secondary transmission of HIV.

Decision Processes

In all fields, decisionmaking under uncertainty requires an iterative process. As the knowledge base for a decision changes, the responsible agency should reexamine the facts and be prepared to change its decision. The agency should also assign specific responsibility for monitoring conditions and identifying opportunities for change. In order to implement these principles at the FDA, the Committee makes

Recommendation 7: The FDA should periodically review important decisions that it made when it was uncertain about the value of key decision variables.

An example illustrates the principle of iterative decisionmaking. During 1983, most blood bank officials opposed asking prospective male donors if they had ever had sex with a man. They were worried that regular donors might take offense and stop donating blood. They were also concerned about some gays would lie about their homosexuality and donate blood in reprisal for being singled out as the target of the questioning. Eventually, some blood collection centers began to ask questions about sexual preference. If the FDA had carefully monitored these experiments, it would have soon learned that the blood bank officials' fears were groundless. The FDA might then have revised its requirements for donor screening to include direct questions about high-risk sexual practices.

Regulatory Efforts

Although the FDA has a great deal of regulatory power over the blood products industry, the agency appears to regulate by expressing its will in subtle, understated directives. This informal approach to regulation is often necessary to permit a timely response and to preserve needed flexibility. The FDA used this approach, for example, in July 1983 when it issued recommendations to withdraw lots of AHF concentrate that plasma fractionators had identified as containing material from a donor that had AIDS. The language in the July 1983 communication failed to specify, however, whether the agency considered the recommendations to be binding on industry. While most regulated industries might have interpreted these letters as mandatory, that question should not have been left to the judgment of individual entities. Taking this into account, the Committee makes

Recommendation 8: Because regulators must rely heavily on the performance of the industry to accomplish blood safety goals, the FDA must articulate its requests or requirements in forms that are understandable and implementable by regulated entities. In particular, when issuing instructions to regulated entities, the FDA should specify clearly whether it is demanding specific compliance with legal requirements or is merely providing advice for careful consideration.

In 1983, the FDA chose a middle ground when faced with the decision to withdraw all AHF concentrate. The agency recommended that plasma fractionators withdraw individual lots of AHF concentrate when a donor was suspected of having AIDS. This decision was certainly defensible. However, the process for this "case-by-case" withdrawal was seriously compromised by the vagueness of the criteria specified for a recall. The agency failed to specify a process for deciding whether a donor may have had AIDS. The agency should have specified a process for reviewing donors who did not fully satisfy the diagnostic criteria for AIDS but who were suspected of having the disease. When deciding whether to withdraw a lot of AHF concentrate, the FDA asked plasma fractionators to take into account the time of the donation in relation to the diagnosis of AIDS and the effect of the recall on product availability. However, the FDA did not specify parameters for assessing either of these decision criteria. With greater forethought, the FDA could have avoided the potential for a seriously flawed implementation of a policy that otherwise appeared to balance benefits, risks, and harms.

Advisory Committees

The FDA made several decisions in 1983 that appear to have been influenced by the blood-industry-based (profit and nonprofit) members of the BPAC. The BPAC membership did not include individuals with expertise in the social, ethical, political, and economic aspects of the issues that BPAC was deliberating at the time. The FDA apparently did not seek independent analysis of the recommendations made by the members of the BPAC, some of whom were employed by the blood industry. In the early 1980s, the FDA appeared too reliant upon analyses provided by industry-based members of the BPAC and the BPAC. For example, see the discussion in Chapter 6 of the July 19, 1983, BPAC meeting which resulted in the decision for case-by-case rather than automatic recall of lots of AHF when one donor was suspected of having AIDs. Chapter 6 also contains a discussion of the December 15, 1983, BPAC meeting, which effectively curtailed actions on surrogate testing of blood for months. The Committee's analysis of the FDA's management of its advisory committee leads to the following three recommendations:

Recommendation 9: The FDA should ensure that the composition of the Blood Products Advisory Committee reflects a proper balance between members who are connected with the blood and blood products industry and members who are independent of industry.

The FDA should select some BPAC members because they can provide independent judgment, question the analyses provided by blood-industry-based BPAC members, and hold the FDA accountable for a high standard of public responsiveness. The BPAC should have at least one voting member who is a representative of consumer interests. BPAC members who vote to establish policy should have neither the appearance of a conflict of interest nor a true conflict of interest.

An agency that is practiced in orderly decisionmaking procedures will be able to respond to the much greater requirements of a crisis. The BPAC meetings cited before Recommendation 9 above provide examples to support this recommendation. Applying this principle to the use of advisory committees, the Committee makes

Recommendation 10: The FDA should tell its advisory committees what it expects from them and should independently evaluate their agendas and their performance.

The FDA staff and its advisory committees should structure their relationship so that they invigorate each other. The agency should hold an advisory committee accountable for its performance through periodic independent evaluation. By placing unresolved issues on future agendas, the committee can hold the FDA accountable for taking follow-up action between committee meetings. The IOM Committee to Study the Use of Advisory Committees by the Food and Drug Administration makes further recommendations to strengthen the FDA advisory committee system (IOM 1992).

Advisory committees provide scientific advice to the FDA; they do not make regulatory decisions for the agency (IOM 1992). As Chapter 6 indicates, the FDA in 1983 did not independently verify the estimates of the risk of blood-product-related HIV infection. The FDA did not analyze the public health implications of the BPAC's recommendation against automatic recall of AHF concentrate that contained plasma from donors suspected of having AIDS. The FDA's lack of independent information and its own analytic capacity meant that it had little choice but to incorporate the advice of the BPAC into its policy recommendations. To ensure the proper degree of independence between the FDA and the blood products industry, the Committee makes

Recommendation 11: The FDA should develop reliable sources of the information that it needs to make decisions about the blood supply. The FDA should have its own capacity to analyze this information and to predict the effects of regulatory decisions.

Communication to Physicians and Patients

One of the crucial elements of the system for collecting blood and distributing blood products to patients is the means by which to convey concern about the risks inherent in blood products. In today's practice of medicine, in contrast to that of the early 1980s, patients and physicians each accept a share of responsibility for making decisions. Patients' informed consent is required for risky procedures. From early 1983, it was clear that AHF concentrate was a risky product. The failure to tell hemophilia recipients of Factor VIII concentrate about the risks of this treatment and about alternative treatments seems especially serious in the light of present-day emphasis on the autonomy of patients in decisions involving their health.

Clinical Practice

One powerful lesson of the AIDS crisis is the importance of telling patients about the potential harms of the treatments that they are about to receive. The NHF dedicated itself to providing information to individuals with hemophilia and their physicians. Their strategy, however, was seriously flawed. As discussed in Chapter 7 , the NHF provided treatment advice, not the information on risks and alternatives that would enable physicians and patients to decide for themselves on a course of treatment. Hemophilia patients did not have the basis for informed choice about a difficult treatment decision.

Considerable scientific and medical uncertainties characterized the early years of the AIDS epidemic. For individuals medically dependent on the use of blood and blood products, these uncertainties created complex dilemmas about clinical options for their continued care. In instances of great uncertainty, it is crucial for patients to be fully apprised of the full range of options available to them and to become active participants in the evaluation of the relative risks and benefits of alternative treatments. As the case studies in Chapter 7 indicate, the failure to communicate adequately about these options prevented many hemophiliacs from making choices in which they accepted responsibility for balancing the risk of AIDS and the risks of bleeding. Ultimately the failure to communicate led to a powerful sense of betrayal that exacerbated the tragedy of the epidemic for many patients and their families. To encourage better communication, the Committee makes

Recommendation 12: When faced with a decision in which the options all carry risk, especially if the amount of risk is uncertain, physicians and patients should take extra care to discuss a wide range of options.

Medicine has many "gray areas" in which the correct course of action is not clear. Guidelines should identify these areas and spotlight the importance of full disclosure of risks, discussion of the broadest range of clinical options, and incorporation of the patient's preferences into an individualized recommendation. Given the inherent risks and uncertainties in all blood products, the public and the providers of care need expert, unbiased information about the blood supply. This information includes risks and benefits, alternatives to using blood products, and recommended best practices. As Chapter 7 indicates, the NHF (the only organization that stepped in to provide information to hemophiliacs and the physicians who were treating them) focused on practice recommendations rather than complete information on risks and options. In order to provide the public and providers of care with the information they need, the Committee makes

Recommendation 13: An expert panel should be created to inform the providers of care and the public about the risks associated with blood and blood products, about alternatives to using them, and about treatments that have the support of the scientific record.

One lesson of the AIDS crisis is that a well-established, orderly decisionmaking process is important for successfully managing a crisis. This applies as much to clinical decisionmaking as to the public health decision process addressed by the earlier recommendations. As the narrative indicates, there are both public health and clinical approaches to reducing the risk of blood-borne diseases. The Blood Safety Council called for in Recommendation 2 would deal primarily with risk assessment and in the public health domain, actions that would reduce the chance that blood products could be vectors of infectious agents. The primary responsibility of the expert panel on best practices called for in Recommendation 13 would be to provide the clinical information that physicians and their patients need to guide their individual health care choices. To be most effective, this panel should be lodged in the Blood Safety Council (see Recommendation 2) so that both bodies can interact and coordinate their activities in order to share information about emerging risks and clinical options.

Any organization that supplies this information must adhere to accepted norms for documenting evidence. The Committee believes that the public's interest would be best served by creating one publicly accountable source of this information. This function would build on the experience of the Agency for Health Care Policy and Research, which has an established guideline development process and issues guidelines on topics such as the management of chronic pain, screening for AIDS, and management of urinary incontinence (El-Sadr, et al. 1994; Jacox, et al. 1994).

Experience in developing practice guidelines for hemophilia treatment and blood transfusion is an important element of preparedness for future threats to the blood supply. There are now well-established processes such as those recommended by the IOM Committee to Advise the Public Health Service on Practice Guidelines (IOM 1990, 1992) and used by the Agency for Health Care Policy and Research. The U.S. Preventive Services Task Force (1989) uses another system process. Guideline developers should perform a thorough literature search, identify well-designed studies, describe fully the evidence on harms and benefits, and explain the connection between the evidence and the recommendations. They should seek critical evaluation from a wide spectrum of individuals and organizations and should periodically reexamine the recommendations in the light of changing knowledge.

Credibility

During the early 1980s, in its role as the guardian of the interests of the hemophilia patient community, the NHF was the principal source of information about using blood products. The outcome of the NHF efforts was that individuals with hemophilia and their families lost faith in the NHF as the rightful steward of their interests. The reasons discussed in Chapter 7 include the NHF's unwavering recommendation to use AHF concentrate, its dependence on funds contributed by the plasma fractionation industry, and the composition of the NHF expert panel (MASAC) that formulated treatment recommendations (e.g., the panel's lack of infectious disease experts and decision analysts).

Toward the end of providing the highest-quality, most credible information to patients and providers, the Committee makes

Recommendation 14: Voluntary organizations that make recommendations about using commercial products must avoid conflicts of interest, maintain independent judgment, and otherwise act so as to earn the confidence of the public and patients.

One of the difficulties with using experts to give advice is the interconnections that experts accumulate during their careers. Organizations that regulate an industry may get advice from the same experts who advise the industries. Organizations that give treatment advice may rely on experts whose employer relies upon support from industry. As a result, an expert may have a history of relationships that raise concerns about whether he or she can be truly impartial when advising a course of action in a complex situation. The Committee believes that the best way to avoid these risks is to choose some panelists who are not expert in the subject of the panel's assignment but have a reputation for expertise in evaluating evidence, sound clinical judgment, and impartiality.

Financial conflicts of interest influence organizations as well as individuals. As indicated in Chapter 7 and above, the financial relationships between the NHF and the blood products industry seriously compromised the NHF's credibility. The standards for acknowledging conflicts of interest are higher than they were 12 years ago. Public health officials and the medical professions must uphold this new standard. Failure to do so will threaten the fabric of trust that holds our society together.

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Aging with hiv/aids.

By the end of the decade, 70% of people living with HIV/AIDS will be older than 50. To bring attention to the impact of HIV/AIDS on the older adult population, ASA and Gilead launched a year-long initiative to help professionals in aging to better support and engage with this demographic.

Panel Discussion

This recording is from a Keynote session with Gilead Sciences at On Aging 2024.

Join Gilead Sciences and the American Society on Aging for a series of conversations about caring for older adults living with HIV. This podcast series covers the opportunities to improve care for those who are aging with HIV—from educating healthcare professionals to ensuring social workers have the resources they need—and examines the experiences of overlooked HIV communities.

Episode 1:  Challenges and Approaches to HIV Care for Older Adults

Caring for older adults—specifically those older than age 50—who are living with HIV calls for increasing access to services and care coordination. HealthHIV’s Pozitively Aging program works to improve the quality of life for those aging with HIV. Scott Bertani, Director of Public Policy at HealthHIV, sits down with Beyond Generations to discuss his article in the Gilead-sponsored Generations Today on how Pozitively Aging addresses obstacles and solutions to HIV care.

Episode 2: The Experiences of Black Men Aging with HIV/AIDS

People living with HIV have historically faced social isolation and stigma from society, however, Black men in particular have faced unique challenges while aging with HIV. Joe Robinson from THRIVE SS sits down with special guest host Raymond A. Jetson from  Aging While Black  to discuss his role as lead program manager of  The Silver Lining Project , a program that aims to create a safe space where older Black men living with HIV can share, discuss and advocate for issues impacting their community.

Episode 3: How Hispanic/Latinx Communities Aging with HIV/AIDS Have Been Overlooked

More than one in every five older adults living with HIV is Hispanic/Latinx. This population living with HIV is a rapidly expanding demographic, and yet they face unique hurdles in accessing healthcare and treatment. Often they have been related to language barriers, but such hurdles also are compounded by feelings of depression and social isolation. Luis Nava Molero from the Latino Commission on AIDS sits down with National Skills Coalition CEO Robert Espinoza to discuss the vulnerabilities of Hispanic/Latinx communities aging with HIV and how they have been overlooked time and again.

Episode 4: How The Denver Principles Are Relevant for Older Adults Living with HIV/AIDS

In 1983, activists developed a manifesto referred to as The Denver Principles, which asserts the rights and responsibilities of people living with HIV, including the right to make meaningful decisions, and declares that they are not passive subjects, but protagonists who are fully involved in their response to AIDS. In this episode, Linda H. Scruggs from Ribbon, a nonprofit organization, and Tez Anderson, President of Let’s Kick Ass—AIDS Survivor Syndrome, sit down with ASA Equity Strategy Director Patrice Dickerson to discuss why The Denver Principles continue to be relevant today, particularly for people aging with HIV.

Episode 5: Educating Healthcare Workers on Caring for People Living and Aging with HIV/AIDS

Many adults who are aging with HIV have experienced immense loss, stigma and discrimination—even within the healthcare system. Unfortunately, the care and treatment they receive often comes from specialists who are unfamiliar with HIV and the unique challenges it poses to older adults. Carole Treston and Sheila Tumilty from the Association of Nurses in AIDS Care address the importance of educating and equipping healthcare workers with the right information and resources to care for people living and aging with HIV.

Episode 6: Giving Social Workers What They Need to Serve Older Adults Living with HIV/AIDS

Social workers are in a unique position because they interact with the broader social determinants of health—such as mental health, housing, employment, etc.—and see firsthand how they impact people living and aging with HIV. Kerry Littlewood from AAJ Research & Evaluation, Inc., and Russell "Rusty" Bennett from the Center for Social Innovation and Health Equity Research, and Collaborative Solutions, Inc., sit down with ASA President & CEO Leanne Clark-Shirley for this episode to discuss what support social workers need to serve older adults living with HIV.

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Thank you to Gilead Sciences for sponsoring this important work!

Gilead Sciences' HIV Age Positively aims to support programs focused on improving the quality of life and health for those who are aging. HIV Age Positively has awarded more than $17.6 million in grants to support 30 organizations—from healthcare organizations to advocacy groups working to address the interrelated challenges within the healthcare system and the general HIV community— addressing stigma, loneliness and better coordination of care.