Evidence map›Paper›PMID 31002583›Full record

Trial reportAJOB empirical bioethics

Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.

Jeremy Sugarman, Li Lin, Jared M Baeten, Thesla Palanee-Phillips, Elizabeth R Brown, Flavia Matovu Kiweewa, Nyaradzo M Mgodi, Gonasagrie Nair, Samantha Siva, Damon M Seils and 2 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AJOB empirical bioethics. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  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

12 authors at 9 institutions in 4 countries.

Jeremy Sugarmana Berman Institute of Bioethics and Department of Medicine , Johns Hopkins University , Baltimore , Maryland , USA.
Li Linb Department of Population Health Sciences , Duke University School of Medicine , Durham , North Carolina , USA.
Jared M Baetenc Global Health, Epidemiology, and Medicine , University of Washington , Seattle , Washington , USA.
Thesla Palanee-Phillipsd Wits Reproductive Health and HIV Institute, University of the Witwatersrand , Johannesburg , South Africa.
Elizabeth R Browne Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center and Department of Biostatistics , University of Washington , Seattle , Washington , USA.
Flavia Matovu Kiweewaf MUJHU Research Collaboration , Kampala , Uganda.
Nyaradzo M Mgodig University of Zimbabwe College of Health Sciences Clinical Trials Research Centre , Harare , Zimbabwe.
Gonasagrie Nairh Desmond Tutu HIV Centre , University of Cape Town , Cape Town , South Africa.
Samantha Sivai HIV Prevention Research Unit , South African Medical Research Council , Durban , South Africa.
Damon M Seilsj Duke Clinical Research Institute , Durham , North Carolina , USA.
Kevin P Weinfurtb Department of Population Health Sciences , Duke University School of Medicine , Durham , North Carolina , USA.ORCID 0000-0002-0046-4353
MTN-020/ASPIRE Study Team
Duke University · USUniversity of Washington · USClinical Research Institute · USDesmond Tutu HIV Foundation · ZAJohns Hopkins University · USMUJHU Research Collaboration · UGSouth African Medical Research Council · ZAUniversity of the Witwatersrand · ZAUniversity of Zimbabwe · 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
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
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
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
PREMIS: Preventive Misconception in HIV Prevention TrialsR21MH092253 · NIMH · DUKE UNIVERSITY · PI SUGARMAN, JEREMY, WEINFURT, KEVIN P · 2010 to 2011
$448k
NIAID NIH HHS U01 AI068633NIAID NIH HHS U01 AI069436NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106707NIMH NIH HHS R21 MH092253
6 · The paper itself

Abstract

backgroundSome HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospective qualitative assessments that did not use a standardized approach.

methodsWe administered a measure of PM called PREMIS, during Microbicide Trials Network 020-A Study to Prevent Infection with a Ring for Extended Use, a large, multicenter, placebo-controlled, phase III trial evaluating the safety and efficacy of a dapivirine vaginal ring among women at risk for HIV infection in Malawi, South Africa, Uganda, and Zimbabwe. The maximum follow-up period was 2.6 years.

resultsOne thousand two hundred sixty-one respondents completed PREMIS at their month 3 visit (M3); 2085 at their month 12 visit (M12); and 1010 at both visits. Most participants expressed high expectations of personal benefit (EPB) and that at least one of the rings used in the trial would reduce the risk of getting HIV (expectation of maximum aggregate benefit or EMAB). There was a moderate positive correlation between EPB and EMAB at M3 (r = .43, 95% CI: .37, .47) and M12 (r = .44, 95% CI: .40, .48). However, there was variability among sites in the strength of the relationship. There was no relationship between either expectation variable and condom use, adherence, or HIV infection.

conclusionsA majority of trial participants expressed some belief that their risk of HIV infection would be reduced by using a vaginal ring, which may signal PM. However, such beliefs were not associated with adherence, condom use, or subsequent HIV infection, and there was variability across sites. Further work is needed to understand these findings.

Indexed as

Risk Reduction BehaviorAdultAnti-HIV AgentsCondomsContraceptive Devices, FemaleFemaleHealth Knowledge, Attitudes, PracticeHIV InfectionsHumansMalawiPatient CompliancePatient Education as TopicPatient ParticipationPyrimidinesSouth AfricaUgandaAnti-HIV AgentsDapivirinePyrimidinesattitudesethicsHIV prevention researchinformed consentPreventive misconception

Identifiers

PMID31002583
PMCPMC6612263
OpenAlexW2938026485

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.