Draft Research Plan
Draft Research Plan for Human Immunodeficiency Virus (HIV) Infection in Pregnant Women: Screening
This opportunity for public comment expired on March 22, 2017 at 8:00 PM EST
Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be 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.
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.
Draft: Proposed Key Questions to Be Systematically Reviewed
- What are the benefits of screening for HIV infection in pregnant women on risk of mother-to-child transmission of HIV infection?
- 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?
- What are the harms of screening for HIV infection in pregnant women?
- What is the effectiveness of newer antiretroviral therapy regimens in reducing mother-to-child transmission of HIV infection?
- What are the harms of newer antiretroviral therapy regimens given during pregnancy to the mother and infant?
Draft: Proposed Research Approach
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).
||Screening studies conducted in low- and middle-income countries, unless fair- or good-quality trials and studies in the United States are lacking|
KQs 1–3: Asymptomatic pregnant women
KQ 4: Pregnant women living with HIV and their infantsKQ 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 exposureKQs 4, 5: Women who are already or were previously taking antiretroviral therapy prior to pregnancy; women with acute HIV infection or HIV subtypes
KQs 1–3: Rapid or standard HIV testingKQs 4, 5: Newer combination antiretroviral therapy regimens
|KQs 4, 5: Women who discontinue antiretroviral therapy during pregnancy; women who experience treatment interruption|
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. anotherKQs 4, 5: Newer combination antiretroviral therapy regimens vs. placebo, older antiretroviral therapy regimens, or another newer combination antiretroviral therapy regimen
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 ratesKQ 5: Harmful effects on pregnancy or neonatal outcomes, effects on exposed children, and long-term cardiovascular and metabolic maternal outcomes
KQs 1, 5: Pharmacokinetics
KQs 1–4: Randomized, controlled trials and controlled observational studiesKQ 5: Randomized controlled trials and controlled observational studies
KQs 1–4: Modeling studiesKQ 5: None
|Timing||KQ 5: Any timing|
Internet Citation: Draft Research Plan: Human Immunodeficiency Virus (HIV) Infection in Pregnant Women: Screening. U.S. Preventive Services Task Force. February 2017.