Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study

BMC Public Health

Leila E. Mansoor¹  Daniel K. Gondwe²  Jared M. Baeten³  Llewellyn Fleurs⁴  Morgan Garcia⁵  Kristine Torjesen⁵  Rachel Scheckter⁵  Ashley J. Mayo⁵  Kubashni Woeber⁶  Nitesha Jeenarain⁶  Zakir Gaffoor⁶  Nishanta Singh⁶  Neetha S. Morar⁶  Doreen Kemigisha⁷  Flavia Matovu Kiweewa⁷  Lydia Soto-Torres⁸  Patrick Ndase⁹  Yvonne Makala^1,10  Petina Musara^1,11  Krishnaveni Reddy^1,12  Thesla Palanee-Phillips^1,12  Ellen Luecke^1,13  Ariane van der Straten^1,14 

[1] Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa;College of Medicine – Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi;Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA;Desmond Tutu HIV Foundation, Emavundleni Clinical Research Site, Cape Town, South Africa;Global Health Population and Nutrition, FHI, 360, Durham, NC, USA;HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa;Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda;National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA;Population Services International (PSI), 1120 19th St. NW, Washington, DC, USA;University of North Carolina Project, Lilongwe, Malawi;University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre, Harare, Zimbabwe;Wits Reproductive Health and HIV Institute (Wits RHI), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;Women’s Global Health Imperative (WGHI) RTI International, Berkeley, CA, USA; ASTRA Consulting, Kensington, CA, USA;Women’s Global Health Imperative (WGHI) RTI International, Berkeley, CA, USA; ASTRA Consulting, Kensington, CA, USA;Center for AIDS Prevention Studies (CAPS), University of California San Francisco, San Francisco, CA, USA;

关键词: Adherence;    Participant engagement;    Microbicides;    Ring;    Dapivirine;    PrEP;    HIV prevention;   

DOI  :  10.1186/s12889-021-11919-x

来源: Springer

【 摘 要 】

BackgroundLow adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebo-controlled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use.MethodsAll sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Residual dapivirine remaining in the last ring returned by each participant was used to estimate drug released from the ring, which was then adjusted for time participants had the ring to calculate probable use categorized into three levels (low/intermittent/high). Product use was connected to PEA attendance using participant identification numbers. We used multivariate Poisson regression with robust standard errors to explore differences in ring use between PEA attendance groups and reviewed qualitative reports for illustrative quotes highlighting participant experiences with PEAs.Results2312 of 2629 study participants attended at least one of 389 PEAs conducted across sites. Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p < 0.05). When controlling for these variables, participants who attended at least one event were more likely to return a last ring showing at least some use (RR = 1.40) than those who never attended an event. There was a stronger correlation between a last returned ring showing use and participant attendance at multiple events (RR = 1.52).ConclusionsOur analysis supports the growing body of work illustrating the importance of meaningfully engaging research participants to achieve study success and aligns with other analyses of adherence support efforts during ASPIRE. While causation between PEA attendance and product use cannot be established, residual drug levels in returned rings strongly correlated with participant attendance at PEAs, and the benefits of incorporating PEAs should be considered when designing future studies of investigational products.

【 授权许可】

CC BY