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

Abstract Background Low 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 ph...

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Autores principales:	Morgan Garcia, Ellen Luecke, Ashley J. Mayo, Rachel Scheckter, Patrick Ndase, Flavia Matovu Kiweewa, Doreen Kemigisha, Petina Musara, Leila E. Mansoor, Nishanta Singh, Kubashni Woeber, Neetha S. Morar, Nitesha Jeenarain, Zakir Gaffoor, Daniel K. Gondwe, Yvonne Makala, Llewellyn Fleurs, Krishnaveni Reddy, Thesla Palanee-Phillips, Jared M. Baeten, Ariane van der Straten, Lydia Soto-Torres, Kristine Torjesen
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Adherence Participant engagement Microbicides Ring Dapivirine PrEP Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/c42e11a6e8a640d9b0d026c07dfa4e70
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spelling	oai:doaj.org-article:c42e11a6e8a640d9b0d026c07dfa4e702021-11-14T12:14:49ZImpact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study10.1186/s12889-021-11919-x1471-2458https://doaj.org/article/c42e11a6e8a640d9b0d026c07dfa4e702021-11-01T00:00:00Zhttps://doi.org/10.1186/s12889-021-11919-xhttps://doaj.org/toc/1471-2458Abstract Background Low 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. Methods All 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. Results 2312 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). Conclusions Our 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.Morgan GarciaEllen LueckeAshley J. MayoRachel ScheckterPatrick NdaseFlavia Matovu KiweewaDoreen KemigishaPetina MusaraLeila E. MansoorNishanta SinghKubashni WoeberNeetha S. MorarNitesha JeenarainZakir GaffoorDaniel K. GondweYvonne MakalaLlewellyn FleursKrishnaveni ReddyThesla Palanee-PhillipsJared M. BaetenAriane van der StratenLydia Soto-TorresKristine TorjesenBMCarticleAdherenceParticipant engagementMicrobicidesRingDapivirinePrEPPublic aspects of medicineRA1-1270ENBMC Public Health, Vol 21, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Adherence Participant engagement Microbicides Ring Dapivirine PrEP Public aspects of medicine RA1-1270
spellingShingle	Adherence Participant engagement Microbicides Ring Dapivirine PrEP Public aspects of medicine RA1-1270 Morgan Garcia Ellen Luecke Ashley J. Mayo Rachel Scheckter Patrick Ndase Flavia Matovu Kiweewa Doreen Kemigisha Petina Musara Leila E. Mansoor Nishanta Singh Kubashni Woeber Neetha S. Morar Nitesha Jeenarain Zakir Gaffoor Daniel K. Gondwe Yvonne Makala Llewellyn Fleurs Krishnaveni Reddy Thesla Palanee-Phillips Jared M. Baeten Ariane van der Straten Lydia Soto-Torres Kristine Torjesen Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
description	Abstract Background Low 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. Methods All 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. Results 2312 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). Conclusions Our 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.
format	article
author	Morgan Garcia Ellen Luecke Ashley J. Mayo Rachel Scheckter Patrick Ndase Flavia Matovu Kiweewa Doreen Kemigisha Petina Musara Leila E. Mansoor Nishanta Singh Kubashni Woeber Neetha S. Morar Nitesha Jeenarain Zakir Gaffoor Daniel K. Gondwe Yvonne Makala Llewellyn Fleurs Krishnaveni Reddy Thesla Palanee-Phillips Jared M. Baeten Ariane van der Straten Lydia Soto-Torres Kristine Torjesen
author_facet	Morgan Garcia Ellen Luecke Ashley J. Mayo Rachel Scheckter Patrick Ndase Flavia Matovu Kiweewa Doreen Kemigisha Petina Musara Leila E. Mansoor Nishanta Singh Kubashni Woeber Neetha S. Morar Nitesha Jeenarain Zakir Gaffoor Daniel K. Gondwe Yvonne Makala Llewellyn Fleurs Krishnaveni Reddy Thesla Palanee-Phillips Jared M. Baeten Ariane van der Straten Lydia Soto-Torres Kristine Torjesen
author_sort	Morgan Garcia
title	Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
title_short	Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
title_full	Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
title_fullStr	Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
title_full_unstemmed	Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
title_sort	impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase iii mtn-020/aspire study
publisher	BMC
publishDate	2021
url	https://doaj.org/article/c42e11a6e8a640d9b0d026c07dfa4e70
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Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study

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