Evidence map›Paper›PMID 21998703›Full record

Trial reportPloS one2011

Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention.

Andrew Mujugira, Jared M Baeten, Deborah Donnell, Patrick Ndase, Nelly R Mugo, Linda Barnes, James D Campbell, Jonathan Wangisi, Jordan W Tappero, Elizabeth Bukusi and 21 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00557245 (Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples), which is not on this map. Cited by 63 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT00557245 phase3completednot on this map

Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

TypeinterventionalSponsorUniversity of WashingtonRan2008 to 2013Enrolled4,758ConditionsHIV-1 Infections, HIV InfectionsArmsTenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  4. Risk of sexual transmission of human immunodeficiency virus with antiretroviral therapy, suppressed viral load and condom use: a systematic review.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
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3 more citing papers are in PubMed but not listed here.

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

31 authors.

Andrew MujugiraDepartment of Global Health, University of Washington, Seattle, Washington, United States of America.
Jared M Baeten
Deborah Donnell
Patrick Ndase
Nelly R Mugo
Linda Barnes
James D Campbell
Jonathan Wangisi
Jordan W Tappero
Elizabeth Bukusi
Craig R Cohen
Elly Katabira
Allan Ronald
Elioda Tumwesigye
Edwin Were
Kenneth H Fife
James Kiarie
Carey Farquhar
Grace John-Stewart
Lara Kidoguchi
Dana Panteleeff
Meighan Krows
Heena Shah
Jennifer Revall
Susan Morrison
Lisa Ondrejcek
Charlotte Ingram
Robert W Coombs
Jairam R Lingappa
Connie Celum
Partners PrEP Study Team

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI027763
6 · The paper itself

Abstract

introductionStable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies. The Partners PrEP Study is a randomized, double-blind, placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples. We describe the trial design and characteristics of the study cohort.

methodsHIV-1 serodiscordant couples, in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy, were enrolled at 9 research sites in Kenya and Uganda. The HIV-1 susceptible partner was randomized to daily oral tenofovir, emtricitabine-tenofovir, or matching placebo with monthly follow-up for 24-36 months.

resultsFrom July 2008 to November 2010, 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled. For 62% (2966/4758) of enrolled couples, the HIV-1 susceptible partner was male. Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners [IQR (28-40) and (26-39) respectively]. Most couples (98%) were married, with a median duration of partnership of 7.0 years (IQR 3.0-14.0) and recent knowledge of their serodiscordant status [median 0.4 years (IQR 0.1-2.0)]. During the month prior to enrollment, couples reported a median of 4 sex acts (IQR 2-8); 27% reported unprotected sex and 14% of male and 1% of female HIV-1 susceptible partners reported sex with outside partners. Among HIV-1 infected partners, the median plasma HIV-1 level was 3.94 log(10) copies/mL (IQR 3.31-4.53) and median CD4 count was 496 cells/µL (IQR 375-662); the majority (64%) had WHO stage 1 HIV-1 disease.

conclusionsCouples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study, the largest efficacy trial of oral PrEP. (ClinicalTrials.gov NCT00557245).

Indexed as

AdenineAdolescentAdultAnti-HIV AgentsCohort StudiesDeoxycytidineEmtricitabineFemaleHeterosexualityHIV-1HIV InfectionsHIV SeronegativityHIV SeropositivityHumansMaleMiddle AgedAdenineAnti-HIV AgentsDeoxycytidineEmtricitabineOrganophosphonatesTenofovir

Identifiers

PMID21998703
PMCPMC3187805

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.