Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study

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dc.contributor.authorWynne, Joshua
dc.contributor.authorMuwawu, Rosemary
dc.contributor.authorMubiru, Michael C.
dc.contributor.authorKamira, Betty
dc.contributor.authorKemigisha, Doreen
dc.contributor.authorNakyanzi, Teopista
dc.contributor.authorKabwigu, Samuel
dc.contributor.authorNakabiito, Clemensia
dc.contributor.authorKiweewa Matovu, Flavia
dc.date.accessioned2022-01-22T17:22:16Z
dc.date.available2022-01-22T17:22:16Z
dc.date.issued2018
dc.description.abstractThe success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results. This paper describes the challenges and specific strategies used to retain participants in a Phase 2B safety and effectiveness study of daily oral and vaginal tenofovir formulations for the prevention of HIV-1 infection in the MTN-003 (VOICE) trial in Kampala, Uganda. Once enrolled, participants were seen every 28 days at the research site and their study product was re-filled. Challenges to retention included a mobile population, non-disclosure of study participation to spouse/family, and economic constraints. Strategies used to maintain high participation rates included the use of detailed locator information, a participant tracking database, regular HIV/STI testing, and the formation of close bonds between staff and subjects. We enrolled 322 women out of the 637 screened. The overall retention rate was 95% over a 3 year follow up period. Only 179 (3%) out of the 6124 expected visits were missed throughout study implementation. Reasons for missed visits included: participants thinking that they did not need frequent visits due to their HIV negative status, time constraints due to commercial sex work, and migration for better employment. With the implementation of multi-faceted comprehensive follow-up and retention strategies, we achieved very high retention rates in the MTN-003 study. This paper provides a blueprint for effective participant retention strategies for other longitudinal HIV prevention studies in resource-limited settings in Sub-Saharan Africa.en_US
dc.identifier.citationJoshua Wynne, Rosemary Muwawu, Michael C Mubiru, Betty Kamira, Doreen Kemigisha, Teopista Nakyanzi, Samuel Kabwigu, Clemensia Nakabiito & Flavia Kiweewa Matovuon behalf of the VOICE Team (2018) Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study, HIV Clinical Trials, 19:5, 165-171, DOI: 10.1080/15284336.2018.1513711en_US
dc.identifier.issn1528-4336 (Print) 1945-5771 (Online)
dc.identifier.urihttps://doi.org/10.1080/15284336.2018.1513711
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/1433
dc.language.isoenen_US
dc.publisherHIV Clinical Trialsen_US
dc.subjectHIVen_US
dc.subjectPreventionen_US
dc.subjectPrEPen_US
dc.subjectRetentionen_US
dc.subjectClinical trialsen_US
dc.subjectSub-Saharan Africaen_US
dc.subjectUgandaen_US
dc.titleMaximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Studyen_US
dc.typeArticleen_US
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