Evidence map›Paper›PMID 30001244›Full record

ArticleAIDS (London, England)2018

Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention.

Renee Heffron, Nelly Mugo, Ting Hong, Connie Celum, Mark A Marzinke, Kenneth Ngure, Stephen Asiimwe, Elly Katabira, Elizabeth A Bukusi, Josephine Odoyo and 4 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in AIDS (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06022809 (Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06022809 nacompletednot on this mapstarted 2023, after this paper: background citation

Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women

TypeinterventionalSponsorMassachusetts General HospitalRan2023 to 2026Enrolled149ConditionsHIV, Other STIsArmsDada Kwa Dada (individual-level), DADA (group-level)
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

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  9. Frontiers in pediatrics · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 3 countries.

Renee HeffronDepartment of Global Health.
Nelly MugoDepartment of Global Health.
Ting HongDepartment of Global Health.
Connie CelumDepartment of Global Health.
Mark A MarzinkeDepartment of Pathology.
Kenneth NgureDepartment of Global Health.
Stephen AsiimweKabwohe Clinical Research Center.
Elly KatabiraInfectious Disease Institute, Makerere University, Kampala, Uganda.
Elizabeth A BukusiDepartment of Global Health.
Josephine OdoyoMicrobiology Research, Kenya Medical Research Institute, Nairobi, Kenya.
Edna TindimwebwaKabwohe Clinical Research Center.
Nulu BulyaInfectious Disease Institute, Makerere University, Kampala, Uganda.
Jared M BaetenDepartment of Global Health.
Partners Demonstration Project and the Partners PrEP Study Teams
Kenya Medical Research Institute · KEMakerere University · UGJohns Hopkins Medicine · USJomo Kenyatta University of Agriculture and Technology · KEUniversity of Washington · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Optimizing Antiretroviral-Based HIV Prevention for HIV Serodiscordant CouplesR01MH095507 · NIMH · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED · 2011 to 2020
$6.1M
Antiretroviral periconception HIV prevention for HIV discordant couplesR00HD076679 · NICHD · UNIVERSITY OF WASHINGTON · PI HEFFRON, RENEE A. · 2015 to 2017
$742k
NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI094189NICHD NIH HHS R00 HD076679NIMH NIH HHS R01 MH095507
6 · The paper itself

Abstract

backgroundGlobal guidelines recommend preexposure prophylaxis (PrEP) use by women at risk for HIV, including during pregnancy, a period with heightened HIV risk. However, data to support safety of PrEP use during pregnancy are limited, particularly from women using PrEP throughout pregnancy.

methodsIn an open-label delivery study of PrEP integrated with ART for high-risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP were offered the option to continue PrEP throughout pregnancy. We compared pregnancy outcomes and 1-year infant growth from pregnancies with exposure to PrEP throughout pregnancy to those without any exposure, with data from the placebo arm of a prior efficacy trial of PrEP conducted in the same setting.

resultsOutcomes from 30 women who elected to continue PrEP throughout pregnancy were compared with those from 96 pregnancies among PrEP-unexposed women. There were small nonsignificant decreases in the frequency of pregnancy loss [16.7% PrEP-exposed versus 23.5% PrEP-unexposed, adjusted odds ratio (aOR) = 0.59, P = 0.4] and preterm delivery [0 versus 7.7%, (aOR) = 0.54, exact P = 0.6]. No congenital anomalies occurred among PrEP-exposed infants. PrEP-exposed infants had slightly lower adjusted mean z-scores for length (-1.73 versus -0.79, P = 0.05) and head circumference (0.24 versus 1.07, P = 0.04) 1 month after birth but were comparable to PrEP-unexposed infants in these measurements 1 year after birth.

conclusionThis first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.

Indexed as

Child DevelopmentMaternal-Fetal ExchangePregnancy OutcomeAdultAnti-HIV AgentsDrug-Related Side Effects and Adverse ReactionsFemaleHIV InfectionsHumansInfant, NewbornKenyaLongitudinal StudiesPre-Exposure ProphylaxisPregnancyTenofovirUgandaAnti-HIV AgentsTenofovir

Identifiers

PMID30001244
PMCPMC6086376
OpenAlexW2804422590

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.