October 2014
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AIDS Research and Human Retroviruses
Background: The success of longitudinal trials depends greatly on effective strategies to retain participants to ensure internal validity. This paper describes the challenges, and strategies in retaining participants in the MTN-003 (VOICE) trial at Ma-kerere University-John Hopkins University Collaboration, Uganda. Methods: A total of 637 women aged 18 to 45 were screened. Once enrolled, participants were seen every 28 days for HIV testing and product refill among other procedures. Retention and visit schedule adherence were critical due to short visit windows. Challenges to good retention included mobile population, poor communication, non-disclosure to family, and economic constraints. Strategies to maintain participation rates included adherence counseling, use of locator information, a tracking database, medical care, and close bonds between staff and participants. Participants were traced by health visitors if they did not come for their visit. Non-adherent participants were scheduled early to allow time for tracing. Results: Of the 637 screened, a total of 322 were enrolled. The overall retention rate was 95%. Only 179 (3%) of the 6124 total visits expected were missed. Reasons for missed visits included being HIV negative and therefore thinking they did not need frequent visits, finding it difficult to attend visits due to sex work, and migration for better employment. There were a total of 18 early terminations; 3 withdrew consent, 9 were lost to follow-up; 5 lost interest and 1 died from a road traffic accident. Conclusions: With the implementation of comprehensive follow-up and retention strategies, high retention rates were achieved. These low technology, labor intensive methods are effective in a low resource setting.