Randomized Controlled Trial

. 2021 Nov 8;21(1):2041.

doi: 10.1186/s12889-021-11919-x.

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

Morgan Garcia¹, Ellen Luecke², Ashley J Mayo³, Rachel Scheckter³, Patrick Ndase⁴, Flavia Matovu Kiweewa⁵, Doreen Kemigisha⁵, Petina Musara⁶, Leila E Mansoor⁷, Nishanta Singh⁸, Kubashni Woeber⁸, Neetha S Morar⁸, Nitesha Jeenarain⁸, Zakir Gaffoor⁸, Daniel K Gondwe⁹, Yvonne Makala¹⁰, Llewellyn Fleurs¹¹, Krishnaveni Reddy¹², Thesla Palanee-Phillips¹², Jared M Baeten¹³, Ariane van der Straten^{2

14}, Lydia Soto-Torres¹⁵, Kristine Torjesen³

Affiliations

¹ Global Health Population and Nutrition, FHI, Durham, NC, 360, USA. mgarcia@fhi360.org.
² Women's Global Health Imperative (WGHI) RTI International, Berkeley, CA, USA; ASTRA Consulting, Kensington, CA, USA.
³ Global Health Population and Nutrition, FHI, Durham, NC, 360, USA.
⁴ Population Services International (PSI), 1120 19th St. NW, Washington, DC, USA.
⁵ Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda.
⁶ University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre, Harare, Zimbabwe.
⁷ Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
⁸ HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa.
⁹ College of Medicine - Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi.
¹⁰ University of North Carolina Project, Lilongwe, Malawi.
¹¹ Desmond Tutu HIV Foundation, Emavundleni Clinical Research Site, Cape Town, South Africa.
¹² Wits Reproductive Health and HIV Institute (Wits RHI), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹³ Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA.
¹⁴ Center for AIDS Prevention Studies (CAPS), University of California San Francisco, San Francisco, CA, USA.
¹⁵ National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

PMID: 34749675
PMCID: PMC8576984
DOI: 10.1186/s12889-021-11919-x

Randomized Controlled Trial

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

Morgan Garcia et al. BMC Public Health. 2021.

. 2021 Nov 8;21(1):2041.

doi: 10.1186/s12889-021-11919-x.

Authors

Affiliations

¹ Global Health Population and Nutrition, FHI, Durham, NC, 360, USA. mgarcia@fhi360.org.
² Women's Global Health Imperative (WGHI) RTI International, Berkeley, CA, USA; ASTRA Consulting, Kensington, CA, USA.
³ Global Health Population and Nutrition, FHI, Durham, NC, 360, USA.
⁴ Population Services International (PSI), 1120 19th St. NW, Washington, DC, USA.
⁵ Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda.
⁶ University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre, Harare, Zimbabwe.
⁷ Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
⁸ HIV Prevention Research Unit (HPRU), South African Medical Research Council (SAMRC), Durban, South Africa.
⁹ College of Medicine - Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi.
¹⁰ University of North Carolina Project, Lilongwe, Malawi.
¹¹ Desmond Tutu HIV Foundation, Emavundleni Clinical Research Site, Cape Town, South Africa.
¹² Wits Reproductive Health and HIV Institute (Wits RHI), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹³ Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA.
¹⁴ Center for AIDS Prevention Studies (CAPS), University of California San Francisco, San Francisco, CA, USA.
¹⁵ National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

PMID: 34749675
PMCID: PMC8576984
DOI: 10.1186/s12889-021-11919-x

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.

Keywords: Adherence; Dapivirine; HIV prevention; Microbicides; Participant engagement; PrEP; Ring.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
Proportion of last returned rings in each ring use category by site-reported PEA attendance

See this image and copyright information in PMC

References

1. UNAIDS. Global HIV & AIDS Statistics - 2020 Fact Sheet [Internet] Geneva; 2020 [cited 2021 Feb 07]. Available from: http://www.unaids.org/en/resources/fact-sheet.
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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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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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