Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

The persistent rate of new HIV infections is the major obstacle to reducing the morbidity and mortality due to HIV in the United States. Screening for HIV in asymptomatic individuals has many potential positive effects, both by identifying HIV-positive individuals at earlier stages of disease in order to improve their own outcomes, as well as by decreasing risky behavior of HIV-positive and HIV-negative persons to reduce transmission of the disease.

As a substantial number of Americans are missed by targeted testing, routine opt-out HIV testing as an alternative to targeted testing should be considered. Almost one quarter of patients with HIV are unaware of their diagnosis, and almost 20,000 infections per year are due to transmission of HIV by persons who are unaware of their diagnosis. Many patients are currently diagnosed too late in the course of their disease to obtain the maximal benefit from treatment.

Screening asymptomatic individuals may lead to a greater number of people being diagnosed at higher CD4 counts, which allows clinicians and patients to make informed decisions about when to start antiretroviral therapy. HAART has been shown to decrease the risk of premature death and disability, and initiation of HAART at CD4 counts of above 350 cells/mm3 is better than waiting until the CD4 count falls below 200 cells/mm3. With recent evidence demonstrating a 70% decrease in mortality in patients who started therapy when their CD4 counts were between 350 and 500 cells/mm3 compared to those who waited until their CD4 count dropped below 350 cells/mm3, the importance of screening in identifying and treating patients at earlier CD4 counts must be critically re-evaluated.

In addition, earlier detection of HIV-positive patients may provide the opportunity for interventions that can reduce the risk of HIV transmission to others, since knowledge of serostatus has been shown to decrease high risk behaviors. As transmission of drug-resistant virus is becoming

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Compare the effects of treatment with HAART (vs other) on quality of life and transmission rates, and the effects of early treatment (as opposed to delayed treatment until symptomatic) on premature death and disability.

Compare whether interventions (e.g., counseling, treatment with HAART) either reduce transmission rates directly, or reduce intermediate outcomes (e.g., viremia, CD4 counts, risky behaviors) that subsequently result in lower transmission rates.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

all asymptomatic adults and adolescents; HIV positive (both asymptomatic and symptomatic)

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

The groups most highly affected by HIV continue to be gay and bisexual men, African-Americans, and Hispanics/Latinos. Approximately 75% of people living with HIV (PLWH) are men, and the dominant means of transmission is through sexual intercourse between men who have sex with men (MSM).

People considered at high risk for HIV infection either have one or more individual risk factors, or are cared for in high-prevalence (> 1%) or high-risk clinical settings. Individual risk factors include men who have had sex with men after 1975; men and women who have concurrent sex partners or two more partners in the last 12 months; men and women who exchange sex for drugs or money; history of or current injection drug use; people with other sexually transmitted diseases (STDs); history of blood transfusion between 1978 and 1985; people whose past or present sex partners were HIV-infected, bisexual, or injection drug users; or people without one of these risk factors but who request HIV testing. High-risk clinical settings include STD clinics, correctional facilities, homeless shelters, tuberculosis clinics, clinics caring for predominately MSM, and adolescent clinics with a high prevalence of STDs. However, targeted screening using these risk factors has been shown to miss between 20% and 74% of patients with HIV.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Indirect outcomes: reduced viremia; improved CD4 counts; reduction of risky behaviors; lower transmission rates

Direct outcomes: reduced premature death and disability; reduced spread of the disease; improved quality of life

Describe any health-related risks, side effects, or harms that you are concerned about.

Harms of screening: There are several potential harms of true-positive HIV tests, including emotional, physical, and professional harms. False positive tests are rare and the harms associated with these are less well-characterized. Acceptability of testing varies widely (10%-97%).

There is little/no evidence on the harms associated with the work-up for HIV infection.

Harms of treatment: HAART is associated with several short-term adverse events, some of which are reversible with a change of regimen. HAART is also associated with long-term adverse events, most notably risk of cardiovascular disease.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Infectious diseases, including HIV/AIDS

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Children
• Elderly

Federal Health Care Program

• Medicaid
• Medicare
• State Children's Health Insurance Program (SCHIP)

Importance

Describe why this topic is important.

In August 2008, the Centers for Disease Control and Prevention (CDC) released new estimates of HIV incidence, using a BED-1 capture enzyme immunoassay and improved statistical methods to more accurately classify infections as recent or long-standing. Based on this analysis, the Centers for Disease Control and Prevention (CDC) now estimates that the total number of adolescents and adults living with HIV in the US at the end of 2006 was 1,106,400. They also estimate that the incidence of HIV has been approximately 55,000 new cases per year between 2003 and 2006, although this number is higher than the previous estimate of 40,000 new cases each year using obtained using older methodology.

Approximately 21% of these people were unaware of their diagnosis. Without treatment, HIV progresses to acquired immunodeficiency syndrome (AIDS) in virtually all patients, defined as having severe immune dysfunction (CD4 T cell count ? 200 cells/mm3) or one or more opportunistic infections. AIDS remains the fifth leading cause of death in people between the ages of 25 and 44, and the seventh leading cause of death in people between the ages of 15 and 24.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

In July 2005, the USPSTF released updated recommendations for screening for HIV in asymptomatic individuals using HIV antibody (Ab) testing. Based on the evidence synthesis carried out in 2005, the USPSTF recommended screening of all non-pregnant adolescents and adults at increased risk for HIV infection (A recommendation) as well as all pregnant women (A recommendation).

However, the USPSTF made no recommendation for or against screening for HIV in non-pregnant adolescents and adults who are not at increased risk for HIV infection (C recommendation).

In 2006, the Centers for Disease Control and Prevention (CDC) recommended routine voluntary screening of all adults between the ages of 13 and 64 in areas where the prevalence of HIV is greater than 0.1%, regardless of other recognized risk factors [25]. The CDC also recommended that HIV testing should be “opt-out,” meaning that all patients should be tested unless they specifically decline, and that prevention counseling and testing be streamlined to reduce barriers to testing.

In November 2006, the USPSTF did a focused review of the new evidence cited by the CDC and released an amendment confirming its “C” recommendation for screening in non-pregnant adolescents and adults not at increased risk for HIV infection in April 2007.

HIV screening was discussed by the USPSTF Topic Prioritization Work Group during a conference call on July 2, 2008. The task force members agreed to recommended that the USPSTF update all HIV recommendations with moderate priority.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

USPSTF and CDC recommendations are not aligned causing uncertainty for clinicians on screening priorities. If clinicians choose to follow a targeted approach to screening, there may be uncertainty who should be routinely screened. There may be uncertainty about the best treatments and strategies.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

The USPSTF will use the evidence report to update its 2005 recommendation on screening for HIV.

Describe the timeframe in which an answer to your question is needed.

The goal of the USPSTF is to update its recommendations every 5 years pursuant to the protocols of the National Guidelines Clearinghouse. The USPSTF would like to begin updating its recommendation statement on screening for HIV by the end of 2010.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

The groups most highly affected by HIV continue to be gay and bisexual men, African-Americans, and Hispanics/Latinos. Approximately 75% of people living with HIV (PLWH) are men, and the dominant means of transmission is through sexual intercourse between men who have sex with men (MSM).

People considered at high risk for HIV infection either have one or more individual risk factors, or are cared for in high-prevalence (> 1%) or high-risk clinical settings. Individual risk factors include men who have had sex with men after 1975; men and women who have concurrent sex partners or two more partners in the last 12 months; men and women who exchange sex for drugs or money; history of or current injection drug use; people with other sexually transmitted diseases (STDs); history of blood transfusion between 1978 and 1985; people whose past or present sex partners were HIV-infected, bisexual, or injection drug users; or people without one of these risk factors but who request HIV testing. High-risk clinical settings include STD clinics, correctional facilities, homeless shelters, tuberculosis clinics, clinics caring for predominately MSM, and adolescent clinics with a high prevalence of STDs. However, targeted screening using these risk factors has been shown to miss between 20% and 74% of patients with HIV.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

The USPSTF will use the evidence report to update its 2005 recommendation on screening for HIV.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

AHRQ supports the USPSTF