Women’s motivations for participating in the dapivirine vaginal ring open label extension study

ABSTRACT

Open-Label Extension (OLE) studies are important in the drug development process and are used to further support the licensing applications and regulatory approvals of products. We aimed to understand why women chose to join the HOPE OLE study – where women were offered the dapivirine vaginal ring after two pivotal trials were completed – through data collected from individual in-depth interviews. Ten women at each of the six HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were enrolled (n = 60). Access to an effective user-initiated HIV prevention product was one of the main reasons women joined HOPE. Although many participants worried that their male partners might expose them to HIV, they chose to remain in their relationships and avoid conflict or confrontation with their partners by discreetly using the ring to protect themselves. Other reasons for joining were quality healthcare, reimbursement and altruism. Researchers should better understand social and personal motivators behind research participation in order to recognize community sociocultural norms and its influences on product acceptability and adherence challenges.

KEYWORDS:

• Women
• dapivirine vaginal ring
• motivation
• HIV prevention

Acknowledgements

We are grateful to all the women that participated in this study, the study staff that implemented this study and the RTI International team for their guidance and expertise with data analysis. We also acknowledge the MTN leadership, MTN 032 management team and FHI360 for protocol development and implementation. Kalendri Naidoo was involved in the study implementation at the study site, data collection, data interpretation, data coding and analysis and writing this article. Elizabeth T. Montgomery was involved in the study design, overall study implementation, data interpretation and article review. Sarita Naidoo was involved in the study design, overall study implementation and article review. Ariana W.K. Katz was involved in the study design, oversaw study implementation, data coding and analysis, data interpretation and article review. Morgan Garcia was involved with overall study implementation and article review. Leila E. Mansoor was involved with study implementation at the study site, data collection and article review.

Ethics statement

The MTN 032 study protocol was approved by the Institutional Review Boards at RTI International, and at each study site and regulated by the U.S. National Institutes of Health and the Microbicide Trials Network.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The data will not be available to the public. If an individual is interested in exploring the data, they should contact the lead author.

Additional information

Funding

The MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) study was designed and implemented by the Microbicide Trials Network (MTN). The MTN is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the United States (US) National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The vaginal rings used in this study were supplied by the International Partnership for Microbicides (IPM).