Evidence map›Paper›PMID 19404392›Full record

Trial reportPloS one2009

Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.

Jairam R Lingappa, Erin Kahle, Nelly Mugo, Andrew Mujugira, Amalia Magaret, Jared Baeten, Elizabeth A Bukusi, Craig R Cohen, Elly Katabira, Allan Ronald and 28 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIControlled Clinical Trial
In one paragraph

Trial report in PloS one, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00194519 (Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples), which is not on this map. Cited by 59 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 6 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT00194519 phase3completednot on this map

Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples

TypeinterventionalSponsorUniversity of WashingtonRan2004 to 2010Enrolled3,408ConditionsHIV Infection, Herpes Simplex, Genital, Sexually Transmitted DiseasesArmsGeneric acyclovir, Placebo
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 6 syntheses or guidelines pooled it, 87 citations in OpenAlex.

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  4. Behavioral interventions for improving dual-method contraceptive use.The Cochrane database of systematic reviews · 2014
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  13. Changes in HIV-1 subtypes B and C genital tract RNA in women and men after initiation of antiretroviral therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013
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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

38 authors at 15 institutions in 9 countries.

Jairam R LingappaDepartment of Global Health, University of Washington, Seattle, Washington, United States of America.
Erin Kahle
Nelly Mugo
Andrew Mujugira
Amalia Magaret
Jared Baeten
Elizabeth A Bukusi
Craig R Cohen
Elly Katabira
Allan Ronald
James Kiarie
Carey Farquhar
Grace John Stewart
Joseph Makhema
M Essex
Edwin Were
Kenneth Fife
Guy Debruyn
Glenda Gray
James McIntyre
Rachel Manongi
Saidi Kapiga
David Coetzee
Susan Allen
Mubiana Inambao
Kayitesi Kayitenkore
Etienne Karita
William Kanweka
Sinead Delany
Helen Rees
Bellington Vwalika
Robert W Coombs
Rhoda Morrow
William Whittington
Lawrence Corey
Anna Wald
Connie Celum
Partners HSV-2/HIV-1 Transmission Study Team
University of Washington · USRwanda Zambia HIV Research Group · RWPerinatal HIV Research Unit · ZAKilimanjaro Christian Medical Centre · TZUniversity of Nairobi · KEUniversity of the Witwatersrand · ZABotswana Harvard AIDS Institute Partnership · BWEmory University · USHarvard University · USIndiana University – Purdue University Indianapolis · USMakerere University · UGMoi University · KEUniversity of California, San Francisco · USUniversity of Cape Town · ZAUniversity of Manitoba · CA

Funding

WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
NIAID NIH HHS AI-38858NIAID NIH HHS P30 AI027757NIAID NIH HHS U01 AI038858
6 · The paper itself

Abstract

backgroundThe Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.

methodsHIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.

resultsOf the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and >500 relative to <350, respectively, p<0.001).

conclusionsThe Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission.

trial registrationClinicalTrials.gov NCT00194519.

Indexed as

Herpesvirus 2, HumanHIV-1Sexual PartnersAcyclovirAdultAfricaAntiviral AgentsCD4 Lymphocyte CountCohort StudiesFemaleFollow-Up StudiesHerpes GenitalisHeterosexualityHIV InfectionsHumansMaleAcyclovirAntiviral AgentsRNA, Viral

Identifiers

PMID19404392
PMCPMC2671170
OpenAlexW2169500947

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.