Evidence map›Paper›PMID 26155597›Full record

Trial reportThe lancet. HIV2015

Risk of HIV-1 acquisition among women who use diff erent types of injectable progestin contraception in South Africa: a prospective cohort study.

Lisa M Noguchi, Barbra A Richardson, Jared M Baeten, Sharon L Hillier, Jennifer E Balkus, Z Mike Chirenje, Katherine Bunge, Gita Ramjee, Gonasagrie Nair, Thesla Palanee-Phillips and 8 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The lancet. HIV, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00705679 (Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
9.6field-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.

NCT00705679 phase2completednot on this map

Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2012Enrolled5,029ConditionsHIV InfectionsArmsEmtricitabine/tenofovir disoproxil fumarate, Emtricitabine/tenofovir disoproxil fumarate placebo, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate placebo, Tenofovir 1% vaginal gel
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 14 institutions in 3 countries.

Lisa M Noguchi
Barbra A Richardson
Jared M Baeten
Sharon L Hillier
Jennifer E Balkus
Z Mike Chirenje
Katherine Bunge
Gita Ramjee
Gonasagrie Nair
Thesla Palanee-Phillips
Pearl Selepe
Ariane van der Straten
Urvi M Parikh
Kailazarid Gomez
Jeanna M Piper
D Heather Watts
Jeanne M Marrazzo
VOICE Study Team
University of Washington · USUniversity of Pittsburgh · USAurum Institute · ZACentre for the AIDS Programme of Research in South Africa · ZAFamily Health International 360 · USFred Hutch Cancer Center · USJohns Hopkins University · USMagee-Womens Hospital · USNational Institute of Allergy and Infectious Diseases · USRTI International · USSouth African Medical Research Council · ZAUnited States Department of State · USUniversity of the Witwatersrand · ZAUniversity of Zimbabwe-University of California San Francisco · ZW

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
South African Medical Research Council Clinical Trials Unit (MRC CTU)UM1AI069422 · NIAID · MEDICAL RESEARCH COUNCIL OF SOUTH AFRICA · PI ABDULLAH, MAHOMED FAREED ABOOBAKER, GOGA, AMEENA · 2012 to 2020
$37.4M
University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials UnitUM1AI069469 · NIAID · UNIVERSITY OF KWAZULU-NATAL · PI QUARRAISHA ABDOOL KARIM · 2012 to 2026
$36.4M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
Johns Hopkins Training Program In STIsT32AI050056 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ELLEN, JONATHAN M. · 2001 to 2015
$3.4M
NIAID NIH HHS T32 AI050056NIAID NIH HHS T32-AI050056NIAID NIH HHS U01 AI068633NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1AI068633NIAID NIH HHS UM1 AI069422NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069469NIAID NIH HHS UM1 AI106707NIAID NIH HHS UM1AI106707
6 · The paper itself

Abstract

backgroundSeveral observational studies have reported that HIV-1 acquisition seems to be higher in women who use depot medroxyprogesterone acetate (DMPA) than in those who do not use hormonal contraception. We aimed to assess whether two injectable progestin-only contraceptives, DMPA and norethisterone enanthate (NET-EN), confer different risks of HIV-1 acquisition.

methodsWe included data from South African women who used injectable contraception while participating in theVOICE study, a multisite, randomised, placebo-controlled trial that investigated the safety and efficacy of three formulations of tenofovir for prevention of HIV-1 infection in women between Sept 9, 2009, and Aug 13, 2012. Women were assessed monthly for contraceptive use and incident infection. We estimated the difference in incident HIV-1infection between DMPA and NET-EN users by Cox proportional hazards regression analyses in this prospective cohort. The VOICE trial is registered with ClinicalTrials.gov, NCT00705679.

findings3141 South African women using injectable contraception were included in the present analysis: 1788 (56·9%)solely used DMPA, 1097 (34·9%) solely used NET-EN, and 256 (8·2%) used both injectable types at different times during follow-up. During 2733·7 person-years of follow-up, 207 incident HIV-1 infections occurred (incidence7·57 per 100 person-years, 95% CI 6·61–8·68). Risk of HIV-1 acquisition was higher among DMPA users (incidence 8·62 per 100 person-years, 95% CI 7·35–10·11) than among NET-EN users (5·67 per 100 person-years, 4·35–7·38;hazard ratio 1·53, 95% CI 1·12–2·08; p=0·007). This association persisted when adjusted for potential confoundingvariables (adjusted hazard ratio [aHR] 1·41, 95% CI 1·06–1·89; p=0·02). Among women seropositive for herpes simplex virus type 2 (HSV-2) at enrolment, the aHR was 2·02 (95% CI 1·26–3·24) compared with 1·09 (0·78–1·52)for HSV-2-seronegative women (pinteraction=0·07).

interpretationAlthough moderate associations in observational analyses should be interpreted with caution, thesefi ndings suggest that NET-EN might be an alternative injectable drug with a lower HIV risk than DMPA in high HIV-1 incidence settings where NET-EN is available.

fundingNational Institutes of Health, Mary Meyer Scholars Fund, and the Ruth Freeman Memorial Fund.

Indexed as

Contraceptive Agents, FemaleMedroxyprogesterone AcetateAdultCohort StudiesContraception BehaviorFemaleFollow-Up StudiesHIV-1HIV InfectionsHumansIncidenceNorethindroneProportional Hazards ModelsRisk FactorsSouth AfricaTenofovirContraceptive Agents, FemaleMedroxyprogesterone AcetateNorethindronenorethindrone enanthateTenofovir

Identifiers

PMID26155597
PMCPMC4491329
OpenAlexW2116728300

What OpenQuestion holds

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LicenceTDM
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.