Final Research Plan: Nonpregnant Adolescents and Adults

Human Immunodeficiency Virus (HIV) Infection: Screening

June 15, 2017

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Panel 1

The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from February 23 to March 22, 2017.

The analytic framework depicts the relationship between the population, intervention, outcomes and harms of screening for HIV. The far left of the framework describes the target population for screening as asymptomatic, nonpregnant adults age 15 years or older. To the right of the population is an arrow corresponding to key question 2, which represents the yield of screening. This arrow leads to both HIV-positive and HIV-negative populations, and the assessment of harms of screening, including false-positive results, anxiety and effects of labeling, and partner discord, abuse, or violence (key question 3). From the HIV-positive population, an arrow leads to disease staging (viral load and CD4 count testing). A subsequent arrow represents the effects of antiretroviral therapy (key question 4) on the outcomes of mortality, AIDs and opportunistic infections, quality of life, functional status, and reduced transmission of HIV and other STIs, as well as assessment of potential harms, including adverse effects associated with antiretroviral therapy, including cardiometabolic outcomes (key question 5). An overarching arrow symbolizing key question 1 spans directly from screening to the final outcomes mentioned above.

* Harms of screening include false-positive results, anxiety and effects of labeling, and partner discord, abuse, or violence.
† Harms of treatment include adverse effects associated with antiretroviral therapy, including cardiometabolic outcomes.

Abbreviations: AIDS=acquired immunodeficiency syndrome; HIV=human immunodeficiency virus; STI=sexually transmitted infection.

  1. What are the benefits of screening for HIV infection in asymptomatic, nonpregnant adolescents and adults on mortality, AIDS and opportunistic infections, quality of life, function, and reduced transmission of HIV and other sexually transmitted infections?
  2. What is the yield (number of new diagnoses per tests performed) of screening for HIV infection at different intervals in asymptomatic, nonpregnant adolescents and adults, and how does the screening yield vary in different risk groups?
  3.  What are the harms of screening for HIV infection in asymptomatic, nonpregnant adolescents and adults?
  4. What are the effects of initiating antiretroviral therapy in adolescents and adults with chronic HIV infection at a higher versus lower CD4 count on mortality, AIDS and opportunistic infections, quality of life, function, and reduced transmission of HIV and other sexually transmitted infections?
  5. What are the longer-term harms (≥2 years) associated with currently recommended antiretroviral therapy regimens?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
Settings
  • Primary care or other settings generalizable to primary care (e.g., family planning clinics, school-based health clinics), other health care settings in which screening is commonly performed (e.g., sexually transmitted infection clinics, emergency room or urgent care)
  • Will focus on studies conducted in the United States and other high-income countries with low prevalence of HIV infection and in which HIV management is similar to that in the United States, unless studies are not available in those settings
 Studies conducted in low- and middle-income countries, unless fair- or good-quality studies from the United States are not available.
Populations* KQs 1–3: Asymptomatic adolescents and adults age 15 years and older

KQs 4, 5: Adolescents and adults living with HIV		 KQs 1–3: Persons who have known HIV infection, are on dialysis, are posttransplant, have occupational exposure (due to risk of needle stick or other parenteral exposure), or have known infection with hepatitis C virus, hepatitis B virus, or tuberculosis

KQ 4: Persons who have acute HIV infection, are on dialysis, or are posttransplant; studies limiting enrollment to persons with hepatitis C virus, hepatitis B virus, or tuberculosis coinfection

KQ 5: Same as for KQ 4, plus persons who are already or were previously taking antiretroviral therapy
Interventions KQs 1–3: Rapid or standard HIV testing

KQs 4, 5: Currently recommended antiretroviral therapy regimens

  
Outcomes KQs 1, 4: Mortality; AIDS and opportunistic infections; quality of life; function; reduced transmission of HIV and other sexually transmitted infections

KQ 2: Number of new diagnoses per number of tests performed

KQ 3: False-positive results, anxiety and effects of labeling, and partner discord, abuse, or violence

KQ 5: Adverse outcomes associated with antiretroviral therapy, including cardiometabolic outcomes		  
Comparisons KQs 1, 3: HIV screening vs. no screening

KQ 2: Repeat HIV screening vs. one-time screening; screening at one interval vs. another

KQ 4: Initiation of antiretroviral therapy at higher vs. lower CD4 counts		  
Study designs KQs 1–3: Randomized, controlled trials and controlled observational studies

KQ 4: Randomized, controlled trials and large controlled observational studies

KQ 5: Randomized, controlled trials and controlled observational studies; will consider treatment series if these study designs are not available		 KQ 1: Uncontrolled observational studies
Timing KQ 5: Long-term followup, defined as ≥2 years  

* For all KQs, subgroups of interest include those defined by sex, age (including adolescents), race/ethnicity, and risk group.

The draft Research Plan was posted for public comment on the USPSTF Web site from February 23, 2017, to March 22, 2017. In response to comments, the USPSTF revised the analytic framework to differentiate the harms of screening from harms of treatment, clarify the diagnostic staging step, and clarify that the evidence review will focus on the benefits and harms of treatment with antiretroviral therapy. The USPSTF also clarified that the subgroups of interest are those defined by sex, age (adolescents and adults), race/ethnicity, and risk group. For KQ 4, the USPSTF clarified that "earlier versus later" initiation of antiretroviral therapy will be based on CD4 count. The USPSTF also replaced the term "newer antiretroviral therapy regimens" with "currently approved antiretroviral therapy regimens."