Draft Research Plan: Pregnant Women

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 pregnant women not known to be HIV-positive. 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 outcome of mother-to-child transmission of HIV infection. 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 outcome. Harms include adverse maternal and infant outcomes associated with use of antiretroviral therapy.

* Includes 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 screening for HIV infection 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 newer antiretroviral therapy regimens in reducing mother-to-child transmission of HIV infection?
  5. What are the harms of newer antiretroviral therapy regimens given during pregnancy to the mother and infant?

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 HIV prevalence, except for randomized trials of antiretroviral therapy
 Screening studies conducted in low- and middle-income countries, unless fair- or good-quality trials and studies in the United States are lacking
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

KQs 4, 5: Women who are already or were previously taking antiretroviral therapy prior to pregnancy; women with acute HIV infection or HIV subtypes
Interventions KQs 1–3: Rapid or standard HIV testing KQs 4, 5: Newer combination 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 or screening at one interval vs. another

KQs 4, 5: Newer combination antiretroviral therapy regimens vs. placebo, older antiretroviral therapy regimens, or another newer combination antiretroviral therapy regimen		  
Outcomes KQ 1: Mother-to-child HIV transmission rates, harms of screening (including false-positive results and anxiety)

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 or neonatal outcomes, effects on exposed children, and long-term cardiovascular and metabolic maternal outcomes

KQs 1, 5: Pharmacokinetics
Study designs KQs 1–4: Randomized, controlled trials and controlled observational studies KQ 5: Randomized controlled trials and controlled observational studies

KQs 1–4: Modeling studies

KQ 5: None
Timing KQ 5: Any timing