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

Abstract

Background: The 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.

How to improve participant compliance and retention in clinical trials：A Scoping Review

“…In chronic non-fatal diseases, the top ve process factors were age (37), economic (30), education (27), gender (27), researchers' skills on communication (25), support from surrounding people (25); the top ve improvement strategies were money, gifts and other compensation (26), paying attention to participants' psychological (23), providing online reminder (22), carrying out education (21), expanding the channels of recruitment (19).…”

“…In some studies with unclear diseases, the top ve process factors were researchers' skills on communication (30), education (27), age (26), trust for the trial (26), support from surrounding people (26); the top ve improvement strategies were paying attention to participants' psychological condition (29), carrying out education (26), money, gifts and other compensation (24), full implementation of informed consent (22), establishing the table of follow-up (20).…”

“…The more complex the study protocol, the higher the compliance and retention [16,22,29,33,34,46,48,53,[56][57][58][61][62][63][64]66,71,72,72,81,82,112,114,117,119,124,125,141,147,149,152,172,180,187,189] 36/182 Frequency of follow-up T 1 Drug / Product Patients who are dissatisfied with drug/product (taste, smell, etc) have worse compliance and retention [14,17,18,22,31,54,57,64,71,74,78,83,87,92,97,…”

“…The better the investigator's communication skills, the higher the patient compliance and retention [6,9,12,[17][18][19][20]22,27,29,31,[38][39][40] The better the researcher's attitude, the higher the patient compliance and retention [6,9,14,19,22,24,25,27,29,31,35,38,42,44,46,50,53,57,58,61,62,65,66,71,74,77,79,80,85,87,88,95,104,105,107,112,114,…”

How to improve participant compliance in clinical trials: A Scoping Review of process factors

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