Evidence map›Paper›PMID 30239426›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2018

Impact of Partner-Related Social Harms on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III Trial.

Thesla Palanee-Phillips, Sarah T Roberts, Krishnaveni Reddy, Vaneshree Govender, Logashvari Naidoo, Samantha Siva, Zakir Gafoor, Arendevi Pather, Flavia Matovu, Kudzai Hlahla and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

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  20. "African journal of AIDS research : AJAR · 2022
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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

18 authors at 11 institutions in 5 countries.

Thesla Palanee-PhillipsWits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.
Sarah T RobertsWomen's Global Health Imperative (WGHI), RTI International, San Francisco, CA.
Krishnaveni ReddyWits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.
Vaneshree GovenderSouth African Medical Research Council, Durban, South Africa.
Logashvari NaidooSouth African Medical Research Council, Durban, South Africa.
Samantha SivaSouth African Medical Research Council, Durban, South Africa.
Zakir GafoorSouth African Medical Research Council, Durban, South Africa.
Arendevi PatherSouth African Medical Research Council, Durban, South Africa.
Flavia MatovuJohns Hopkins University Research Collaboration, Makerere University, Kampala, Uganda.
Kudzai HlahlaClinical Trials Unit, College of Health Sciences, UZCHS-CTU University of Zimbabwe, Harare, Zimbabwe.
Bonus MakananiJohns Hopkins University Research Project, Malawi College of Medicine, Queen Elizabeth Central Hospital, Blantyre, Malawi.
Gonasagrie NairCenter for AIDS Programme of Research in South Africa (CAPRISA) Durban, South Africa.
Katie SchwartzFHI 360, Durham, NC.
Kristine TorjesenFHI 360, Durham, NC.
Elizabeth BrownStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA.
Lydia Soto-TorresNational Institute of Allergy and Infectious Diseases, Washington, DC.
Jared BaetenDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA.
Elizabeth T MontgomeryWomen's Global Health Imperative (WGHI), RTI International, San Francisco, CA.
South African Medical Research Council · ZAFamily Health International 360 · USPerinatal HIV Research Unit · ZARTI International · USCentre for the AIDS Programme of Research in South Africa · ZAFred Hutch Cancer Center · USJohns Hopkins University · USMUJHU Research Collaboration · UGNational Institute of Allergy and Infectious Diseases · USUniversity of Washington · USUniversity of Zimbabwe · ZW

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Judith Tsui · 1988 to 2026
$104.9M
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
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
BIOMEDICAL INFORMATION DEVELOPMENT IN SUB-SAHARAN AFRICAD43TW001081 · FIC · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 1998 to 2003
$435k
FIC NIH HHS D43 TW001081NIAID NIH HHS P30 AI027757NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069422NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069469NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

backgroundLong-acting female-initiated methods such as the dapivirine ring may give women greater agency in HIV-1 prevention. However, social harms, defined as nonmedical adverse consequences of study participation or dapivirine ring use, may reduce product adherence and consequently HIV-1 protection.

methodsWe assessed whether experiencing social harms from male partners was associated with lower adherence to the dapivirine ring in the MTN-020/ASPIRE trial. Reports of social harms were solicited quarterly. Low adherence was defined by plasma dapivirine levels ≤95 pg/mL or residual dapivirine levels in returned rings >23.5 mg.

resultsAmong 2629 women enrolled in ASPIRE, 85 (3.2%) reported 87 social harms during a median follow-up of 1.6 years. Women were significantly more likely to have low adherence, measured by plasma dapivirine levels, at visits with a social harm in the past month than at visits where no social harm was reported (adjusted risk ratio 2.53, 95% confidence interval: 1.37 to 4.66, P = 0.003). There was no association for social harms reported ≥1 month prior, suggesting an acute, short-term effect. Women were significantly more likely to not return a ring at visits with a social harm reported (adjusted risk ratio 24.70, 95% confidence interval: 18.57 to 32.85, P < 0.001). In rings that were returned, social harms were not associated with residual dapivirine levels.

conclusionsAlthough social harms were uncommon (<5% of women with >1 year of use), participants reporting social harms by male partners had lower adherence to the dapivirine ring. Strategies to mitigate nonadherence to product use related to social harms should be evaluated in future studies of female-controlled HIV-1 prevention options.

Indexed as

Contraceptive Devices, FemaleDrug MonitoringAdultAnti-HIV AgentsFemaleHIV InfectionsHumansIntimate Partner ViolencePyrimidinesYoung AdultAnti-HIV AgentsDapivirinePyrimidines

Identifiers

PMID30239426
PMCPMC6231955
OpenAlexW2893225762

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.