Evidence map›Paper›PMID 26061040›Full record

Trial reportPloS one2015

Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.

Thesla Palanee-Phillips, Katie Schwartz, Elizabeth R Brown, Vaneshree Govender, Nyaradzo Mgodi, Flavia Matovu Kiweewa, Gonasagrie Nair, Felix Mhlanga, Samantha Siva, Linda-Gail Bekker and 11 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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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

21 authors at 12 institutions in 5 countries.

Thesla Palanee-PhillipsWits Reproductive Health and HIV Research Institute, University of the Witswatersrand, School of Clinical Medicine, Johannesburg, South Africa.
Katie SchwartzFHI 360, Durham, NC, United States of America.
Elizabeth R BrownStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
Vaneshree GovenderHIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
Nyaradzo MgodiUniversity of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF) Research Collaboration, Harare, Zimbabwe.
Flavia Matovu KiweewaMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Gonasagrie NairCentre for AIDS Programme of Research in SA (CAPRISA), Durban, South Africa.
Felix MhlangaUniversity of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF) Research Collaboration, Harare, Zimbabwe.
Samantha SivaHIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
Linda-Gail BekkerDesmond Tutu HIV Foundation Clinical Research Site, Cape Town, South Africa.
Nitesha JeenarainHIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
Zakir GaffoorHIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
Francis MartinsonUNC Lilongwe Clinical Research Site, Lilongwe, Malawi.
Bonus MakananiCollege of Medicine-John Hopkins University Research Project Queen Elizabeth Central Hospital, Blantyre, Malawi.
Sarita NaidooHIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
Arendevi PatherHIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
Jessica PhillipHIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
Marla J HusnikStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
Ariane van der StratenRTI International, San Francisco, CA, United States of America.
Lydia Soto-TorresDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Mental Health, and Eunice Shriver Kennedy, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States of America.
Jared BaetenDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, United States of America.
South African Medical Research Council · ZAFred Hutch Cancer Center · USUniversity of Zimbabwe-University of California San Francisco · ZWCentre for the AIDS Programme of Research in South Africa · ZADesmond Tutu HIV Foundation · ZAFamily Health International 360 · USMUJHU Research Collaboration · UGNational Institutes of Health · USQueen Elizabeth Central Hospital · MWRTI International · USUniversity of the Witwatersrand · ZAUniversity of Washington · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
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
University of Cape Town Clinical Trials Unit (UCTCTU)UM1AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI Linda-Gail Bekker · 2012 to 2026
$36.3M
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARY Glenn Fowler, Philippa Musoke · 2012 to 2026
$34.8M
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
NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1AI068633NIAID NIH HHS UM1 AI069422NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069469NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI069519NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106707NIAID NIH HHS UM1AI106707
6 · The paper itself

Abstract

introductionWomen in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication over a month or longer, may reduce these adherence challenges.

methodsASPIRE (A Study to Prevent Infection with a Ring for Extended Use) is a phase III, randomized, double-blind, placebo-controlled trial testing the safety and effectiveness of a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine for prevention of HIV-1 infection. We describe the baseline characteristics of African women enrolled in the ASPIRE trial.

resultsBetween August 2012 and June 2014, 5516 women were screened and 2629 HIV-1 seronegative women between 18-45 years of age were enrolled from 15 research sites in Malawi, South Africa, Uganda, and Zimbabwe. The median age was 26 years (IQR 22-31) and the majority (59%) were unmarried. Nearly 100% of participants reported having a primary sex partner in the prior three months but 43% did not know the HIV-1 status of their primary partner; 17% reported additional concurrent partners. Nearly two-thirds (64%) reported having disclosed to primary partners about planned vaginal ring use in the trial. Sexually transmitted infections were prevalent: 12% had Chlamydia trachomatis, 7% Trichomonas vaginalis, 4% Neisseria gonorrhoeae, and 1% syphilis.

conclusionsAfrican HIV-1 seronegative women at risk of HIV -1 infection were successfully enrolled into a phase III trial of dapivirine vaginal ring for HIV-1 prevention.

Indexed as

VaginaAdolescentAdultAfrica South of the SaharaDouble-Blind MethodFemaleHIV-1HIV InfectionsHumansMiddle AgedPyrimidinesYoung AdultDapivirinePyrimidines

Identifiers

PMID26061040
PMCPMC4489588
OpenAlexW2176788474

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Registered trials

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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.