Final Research Plan: Pregnant Women

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 pregnant women not known to have pre-existing HIV infection. To the right of the population is an arrow corresponding to key question 2, which represents screening. This arrow leads to screening 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 outcome of mother-to-child transmission of HIV infection and assessment of potential harms, including adverse maternal and infant outcomes associated with use of antiretroviral therapy (key question 5). An overarching arrow symbolizing key question 1 spans directly from screening to the final health outcome 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 maternal and infant outcomes associated with use of antiretroviral therapy.

Abbreviation: HIV=human immunodeficiency virus.

  1. What are the benefits of screening for HIV infection in pregnant women on risk of mother-to-child transmission of HIV infection?
  2. What is the yield (number of new diagnoses per number of tests performed) of repeat HIV screening at different intervals in pregnant women, and how does the yield of screening vary in different risk groups?
  3. What are the harms of screening for HIV infection in pregnant women?
  4. What is the effectiveness of currently recommended antiretroviral therapy regimens for reducing mother-to-child transmission of HIV infection?
  5. What are the harms of currently recommended antiretroviral therapy regimens given during pregnancy to the mother and infant?

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., prenatal, antenatal, and family planning clinics) and other health care settings in which screening is commonly performed (e.g., 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 management of HIV infection is similar to that in the United States, except for randomized trials of antiretroviral therapy
 Studies of screening conducted in low and middle-income countries, unless fair- or good-quality studies in the United States are not available.
Populations KQs 1–3: Asymptomatic pregnant women

KQ 4: Pregnant women living with HIV and their infants

KQ 5: Women who received antiretroviral therapy regimens while pregnant; neonates, infants, and children who were exposed to antiretroviral therapy in utero		 KQs 1–3: Women who have known HIV infection, are on dialysis, are posttransplant, or have occupational exposure (due to risk of needle stick or other parenteral exposure); women with known infection with hepatitis C virus, hepatitis B virus, or tuberculosis

KQs 4, 5: Women who are already or were previously taking antiretroviral therapy prior to pregnancy; women with acute HIV infection; studies limiting enrollment to persons with hepatitis C virus, hepatitis B virus, or tuberculosis coinfection
Interventions KQs 1–3: Rapid or standard HIV testing

KQs 4, 5: Currently recommended antiretroviral therapy regimens		 KQs 4, 5: Women who discontinue antiretroviral therapy during pregnancy; women who experience treatment interruption
Comparisons KQs 1, 3: HIV screening vs. no screening

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

KQs 4, 5: Currently recommended antiretroviral therapy regimens vs. placebo, older antiretroviral therapy regimens, or one another		  
Outcomes KQ 1: Mother-to-child HIV transmission rates

KQ 2: Number of positive tests per number of screening tests performed

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

KQ 4: Mother-to-child HIV transmission rates

KQ 5: Harmful effects on pregnancy outcomes, neonatal outcomes, or exposed children; long-term cardiovascular and metabolic maternal outcomes		 KQs 1, 5: Pharmacokinetic outcomes
Study designs KQs 1–4: Randomized, controlled trials and controlled observational studies

KQ 5: Randomized trials and controlled observational studies		 KQs 1–4: Modeling studies
Timing KQ 5: Any timing  

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 the 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 study settings will include prenatal, antenatal, and family planning clinics; replaced the term "newer antiretroviral therapy" with "currently approved antiretroviral therapy"; and revised the criteria for study populations to exclude persons with hepatitis C virus, hepatitis B virus, or tuberculosis coinfection. The USPSTF decided not to add benefits of initiating long-term antiretroviral therapy in women as a result of prenatal screening as an outcome because the evidence review will focus on the effects of screening on mother-to-child transmission. The general benefits of long-term antiretroviral therapy will be addressed in a separate evidence review on screening for HIV infection in nonpregnant persons.