Evidence map›Paper›PMID 30683103›Full record

ArticleBMC women's health2019

Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

Ariana W K Katz, Barbara S Mensch, Kubashni Woeber, Petina Musara, Juliane Etima, Ariane van der Straten

Registry-linked trialAbstract read
In one paragraph

Article in BMC women's health, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02358616 (An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–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.

NCT02358616 completednot on this map

An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial

TypeobservationalSponsorMicrobicide Trials NetworkRan2012 to 2014Enrolled219ConditionsHIV Prevention
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  10. Observational
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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

6 authors.

Ariana W K KatzWomen's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA. awkatz@rti.org.ORCID 0000-0001-5742-4953
Barbara S MenschPopulation Council, New York, NY, USA.
Kubashni WoeberSouth African Medical Research Council, HIV Prevention Research Unit, Durban, South Africa.
Petina MusaraUniversity of Zimbabwe College of Health Sciences Clinical Trials Research Centre (UZCHS-CTRC), Harare, Zimbabwe.
Juliane EtimaMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Ariane van der StratenWomen's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA.

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
Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
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
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARY Glenn Fowler, Philippa Musoke · 2012 to 2026
$34.8M
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 U01 AI069436NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069422NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106707NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundIn biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants.

methodsVOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings.

resultsParticipants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception.

conclusionsWomen's participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants.

trial registrationNCT02358616 ; Posted February 9, 2015, retrospectively registered.

Indexed as

Administration, IntravaginalAdultClinical Trials, Phase II as TopicFemaleHIV InfectionsHumansMedication AdherenceMiddle AgedMotivationPatient Acceptance of Health CarePatient PreferencePre-Exposure ProphylaxisQualitative ResearchRetrospective StudiesSelf ReportSurveys and QuestionnairesVaginal Creams, Foams, and JelliesClinical trialsHIV preventionMicrobicidesMotivation to participateOral PrEPVOICE trial

Identifiers

PMID30683103
PMCPMC6347781

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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.