Evidence map›Paper›PMID 39158801›Full record

Trial reportAIDS and behavior2024

Efficacy of the Dapivirine Vaginal Ring Accounting for Imperfect Adherence.

Marla J Husnik, Renee Heffron, James P Hughes, Barbra Richardson, Ariane van der Straten, Thesla Palanee-Phillips, Lydia Soto-Torres, Devika Singh, Brenda Gati Mirembe, Edward Livant and 7 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in AIDS and behavior, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. 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

17 authors.

Marla J HusnikDepartment of Epidemiology, University of Washington, Seattle, WA, USA.ORCID http://orcid.org/0000-0001-7032-6944
Renee HeffronDepartment of Epidemiology, University of Washington, Seattle, WA, USA.
James P HughesDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Barbra RichardsonDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Ariane van der StratenDepartment of Medicine, The Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.
Thesla Palanee-PhillipsFaculty of Health Sciences, Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.
Lydia Soto-TorresNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Devika SinghUniversity of Pittsburgh, Pittsburgh, PA, USA.
Brenda Gati MirembeMakerere University John Hopkins University Research Collaboration (MU-JHU), Kampala, Uganda.
Edward LivantMagee-Womens Research Institute, Pittsburgh, PA, USA.
Zakir GaffoorHIV Prevention Research Unit, South African Medical Research Council, Cape Town, South Africa.
Leila E MansoorCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
Samantha S SivaHIV Prevention Research Unit, South African Medical Research Council, Cape Town, South Africa.
Sufia DadabhaiJohns Hopkins Bloomberg School of Public Health, Blantyre, Malawi.
Flavia Matovu KiweewaMakerere University John Hopkins University Research Collaboration (MU-JHU), Kampala, Uganda.
Jared M BaetenDepartment of Epidemiology, University of Washington, Seattle, WA, USA. jbaeten@uw.edu.
MTN-020/ASPIRE Study Team

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
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
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials UnitUM1AI069469 · NIAID · UNIVERSITY OF KWAZULU-NATAL · PI QUARRAISHA ABDOOL KARIM · 2012 to 2026
$36.4M
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
Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases UM1AI068615Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases UM1AI068633Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases UM1AI106707NIAID NIH HHS P30 AI036219NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069469NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

Product adherence is critical to obtaining objective estimates of efficacy of pre-exposure prophylactic interventions against HIV-1 infection. With imperfect adherence, intention-to-treat analyses assess the collective effects of complete, sub-optimal and non-adherence, providing a biased and attenuated estimate of the average causal effect of an intervention. Using data from the MTN-020/ASPIRE phase III trial evaluating HIV-1 efficacy of the dapivirine vaginal ring, we conducted per-protocol, and adherence-adjusted causal inference analyses using principal stratification and marginal structural models. We constructed two adherence cut offs of ≥ 0.9 mg (low cutoff) and > 4.0 mg (high cutoff) that represent drug released from the ring over a 28-day period. The HIV-1 efficacy estimate (95% CI) was 30.8% (3.6%, 50.3%) (P = 0.03) from the per-protocol analysis, and 53.6% (16.5%, 74.3%) (P = 0.01) among the highest predicted adherers from principal stratification analyses using the low cutoff. Marginal structural models produced efficacy estimates (95% CIs) ranging from 48.8 (21.8, 66.4) (P = 0.0019) to 56.5% (32.8%, 71.9%) (P = 0.0002). Application of adherence-adjusted causal inference methods are useful in interpreting HIV-1 efficacy in secondary analyses of PrEP clinical trials.

Indexed as

Anti-HIV AgentsContraceptive Devices, FemaleHIV-1HIV InfectionsPyrimidinesAdultDrug MonitoringFemaleHumansIntention to Treat AnalysisPre-Exposure ProphylaxisTreatment OutcomeAnti-HIV AgentsDapivirinePyrimidinesCausal inferenceDapivirineEfficacyHIV-1 preventionIntravaginal ringNon-adherence

Identifiers

PMID39158801
PMCPMC11530124

What OpenQuestion holds

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Registered trials

None linked

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.