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. 2019 Jan 25;19(1):18.
doi: 10.1186/s12905-019-0713-6.

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

Ariana W K Katz  1 , Barbara S Mensch  2 , Kubashni Woeber  3 , Petina Musara  4 , Juliane Etima  5 , Ariane van der Straten  6   7
Affiliations

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

Ariana W K Katz et al. BMC Womens Health. .

Abstract

Background: In 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.

Methods: VOICE-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.

Results: Participants 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.

Conclusions: Women'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 registration: NCT02358616 ; Posted February 9, 2015, retrospectively registered.

Keywords: Clinical trials; HIV prevention; Microbicides; Motivation to participate; Oral PrEP; VOICE trial.

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Conflict of interest statement

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments, or comparable ethical standards. The study protocol was approved by the Institutional Review Boards at RTI International and at each of the study sites (South African Medical Research Council (MRC) – Isipingo and Overport; Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration; and University of Zimbabwe College of Health Sciences Clinical Trials Unit (UZCHS CTU) – Seke South and Zengeza) and was overseen by the regulatory infrastructure of the U.S. National Institutes of Health and the Microbicide Trials Network (MTN). Written informed consent was obtained from all individual participants included in the study.

Consent for publication

All participants are notified during informed consent that any publication of this study will not use names or personal identifiers. As stated in the Methods section, all names used in this paper are pseudonyms. No images or videos of an individual person are included in this manuscript.

Competing interests

The authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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