Issues: Recruitment of participants and retention are critical in HIV prevention trials. This paper describes strategies used to recruit and retain HIV-negative women into a vaginal microbicide efficacy trial in rural Uganda. The trial is part of the Microbicide Development Programme (MDP), an international collaboration of African and UK research institutions. Description: HIV-negative women are recruited from HIV-1 discordant and some HIV concordant negative couples through surveys and Voluntary Counseling Testing (VCT) centres. Strategies to enhance recruitment include involvement of AIDS care and support organizations, local leaders and meetings with the general community. Efforts to enhance retention into trial include followup couple counselling, regular provision of study information and couple workshops to share experiences and to collate community concerns. We also secured the help of participants' leaders (one male; one female) in each community to enhance recruitment and retention. These were trained in leadership and communication skills with refresher training performed every three months. They mobilize couples for VCT and recruitment, offer support visits, collate information on trial related concerns and give feedback to both the research team and participants. Use of multiple approaches has ensured that recruitment into the trial is on target, and that follow-up rates are excellent (>95%). Participant leaders even managed to successfully encourage couples who declined VCT during the initial house-to-house recruitment survey to participate. The leaders' network has ensured quick and efficient communication between participants and research team. Following the closure of the Cellulose Sulphate trial, participants' leaders played a key role in correcting misleading information that microbicide trials are generally harmful to volunteers. We did not observe barriers to participation related to stigma, marriage dissolution or marital violence Conclusion: Working with community based organizations and with participants' leaders has proved to be an effective approach to enhance recruitment and retention in this trial.
Basajja, V. Strategies to recruit and retain couples in a vaginal microbicides trial of pro2000/5 in a rural community, SW Uganda. Presented at Microbicides 2008, New Delhi, India, 24-27 February 2008. (2008)