Evidence map›Paper›PMID 38099506›Full record

Trial reportThe Journal of infectious diseases2024

Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring.

Randy M Stalter, Tracy Q Dong, Craig W Hendrix, Thesla Palanee-Phillips, Ariane van der Straten, Sharon L Hillier, Flavia M Kiweewa, Nyaradzo M Mgodi, Mark A Marzinke, Linda-Gail Bekker and 4 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01617096 (A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 38% 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.

NCT01617096 phase3completednot on this map

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women

TypeinterventionalSponsorInternational Partnership for Microbicides, Inc.Ran2012 to 2015Enrolled2,629ConditionsHIV InfectionsArmsDapivirine Vaginal Ring, Placebo Ring
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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 10 institutions in 4 countries.

Randy M StalterDepartment of Epidemiology, University of Washington, Seattle, WA, USA.
Tracy Q DongVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Craig W HendrixDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Thesla Palanee-PhillipsDepartment of Epidemiology, University of Washington, Seattle, WA, USA.
Ariane van der StratenCenter for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
Sharon L HillierDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Flavia M KiweewaResearch Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Nyaradzo M MgodiClinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Linda-Gail BekkerThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Lydia Soto-TorresDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Jared M BaetenDepartment of Epidemiology, University of Washington, Seattle, WA, USA.
Elizabeth R BrownVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
MTN-020/ASPIRE Study Team
University of Washington · USUniversity of the Witwatersrand · ZADesmond Tutu HIV Foundation · ZAJohns Hopkins University · USMUJHU Research Collaboration · UGNational Institutes of Health · USUniversity of Zimbabwe · ZWFred Hutch Cancer Center · USUniversity of California, San Francisco · USUniversity of Pittsburgh · US

Funding

SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
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
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
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Alan David Levine · 1994 to 2026
$50.0M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
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
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
VENEREAL DISEASET32AI007140 · NIAID · UNIVERSITY OF WASHINGTON · PI Julia Cook Dombrowski · 1985 to 2026
$19.4M
NIAID NIH HHS P30 AI036219NIAID NIH HHS T32 AI007044NIAID NIH HHS T32 AI007140NIAID NIH HHS U01 AI068633NIAID NIH HHS U01 AI069436NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106707NIH HHS UM1AI068633NIMH NIH HHS
6 · The paper itself

Abstract

backgroundConfounding introduced by individuals' sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use.

methodsWe conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18-45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use.

resultsWomen in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8-3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9-4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%-80%) per-sex-act HIV-1 risk reduction.

conclusionsThese results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use. CLINICAL TRIALS REGISTRATION: NCT01617096.

Indexed as

Anti-HIV AgentsContraceptive Devices, FemaleHIV-1HIV InfectionsHIV SeropositivityPyrimidinesAdolescentAdultFemaleHumansMiddle AgedRisk Reduction BehaviorYoung AdultAnti-HIV AgentsDapivirinePyrimidinesdapivirineHIV-1per sex actpreexposure prophylaxisvaginal ring

Identifiers

PMID38099506
PMCPMC11011174
OpenAlexW4389794616

What OpenQuestion holds

Textmetadata
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.