Draft Research Plan: Nonpregnant Adolescents and Adults

Human Immunodeficiency Virus (HIV) Infection: Screening

February 23, 2017

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Figure 1. Analytic Framework. 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 screening. This arrow leads to both HIV-positive and HIV-negative populations. Screening may lead to harms, which correspond to key question 3. From the HIV-positive population, an arrow leads to viral load and CD4 count testing. An arrow coming out of viral load and CD4 count testing represents key question 4. It leads to the outcomes of mortality, AIDs and opportunistic infections, quality of life, function, and reduced transmission of HIV and other sexually transmitted diseases. Interventions may lead to harms, which correspond to key question 5. An overarching arrow symbolizing key question 1 goes directly from screening to confirmatory testing, to interventions, and then to the same list of outcomes. Harms of interventions include outcomes associated with antiretroviral therapy, including cardiometabolic outcomes.

* Includes adverse outcomes associated with antiretroviral therapy, including cardiometabolic outcomes.

Abbreviations: AIDS=acquired immune deficiency syndrome; HIV=human immunodeficiency virus; STD=sexually transmitted disease.

  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 diseases?
  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 yield of screening 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 earlier versus later initiation of antiretroviral therapy in adolescents and adults with chronic HIV infection on mortality, AIDS and opportunistic infections, quality of life, function, and reduced transmission of HIV and other sexually transmitted diseases?
  5. What are the longer-term harms associated with newer antiretroviral therapy regimens?

The Proposed 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) and other health care settings in which screening is commonly performed (e.g., emergency room or urgent care)
  • Studies conducted in the United States and other high- income countries with low prevalence of HIV infection, unless studies are not available in those settings
 Studies conducted in low- and middle-income countries, unless fair- or good-quality trials from the United States are lacking
Populations KQs 1–3: Asymptomatic, nonpregnant adolescents and adults age 15 years and older

KQs 4, 5: Adolescents and adults living with HIV

 KQs 1, 2: Persons who have known HIV infection, are on dialysis, are posttransplant, have occupational exposure, or have known coinfection with hepatitis C, hepatitis B, or tuberculosis

KQ 3: Same as for KQs 1 and 2, plus persons who are at high risk for HIV infection

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

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

KQs 4, 5: Antiretroviral therapy regimens

  
Outcomes KQs 1, 4:
  • Mortality
  • AIDS and opportunistic infections
  • Quality of life
  • Function
  • Reduced transmission of HIV and other sexually transmitted diseases

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

KQ 3: Adverse outcomes associated with antiretroviral therapy, including cardiometabolic outcomes; 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 or screening at one interval vs. another

KQ 4: Initiation of antiretroviral therapy earlier vs. later

  
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 types of studies are lacking		 KQ 1: Uncontrolled observational studies
Timing KQ 5: Long-term followup, defined as ≥2 years