Recruitment and retention in a vaginal microbicide efficacy trial: experiences with HIV negative women living in discordant couple relationships in rural SW Uganda.
Abstract
Background: We describe recruitment and retention rates among women living in HIV discordant and some HIV-concordant negative couple relationships in a phase III vaginal microbicide trial. This study is part of the Microbicides Development Programme (MDP), a multi-centre collaboration involving African and UK institutions. Methods: Discordant couples are identified at HIV voluntary counseling and testing (VCT) clinics and through house-to-house surveys. After obtaining informed consent, participants are enrolled and receive instructions on gel use and a 4-week gel supply. Further dispensing is done through monthly home visits. Clinical follow-up visits are conducted every 3 months including STI screening, pregnancy test, family planning counseling and couple VCT. Results: Between Jan 2005 and June 2007 a total of 663 M+F- discordant couples were identified. Of these, 618 women (93%) were screened and 472 (76%) met the study inclusion criteria (16/month). Reasons for exclusion were: HIV sero-conversion before enrolment (31); pregnancy (25); clinical/laboratory abnormalities (19); reporting not to be sexually active (10); no regular sexual partner (11); unwilling to share HIV results with partner (6); unwilling to use condoms (4); refusal to participate (17); and other reasons (23). Overall 29% of identified couples were not enrolled. So far, the trial is recruiting at 80% of the target. The overall retention rate at one year was 96% and rates at 3, 6 and 9 months were 96%, 98%, 94% respectively. A total of 24 women have been withdrawn due to personal decision (16), influenced by the death of partner in 7 women and relocation (8) Conclusions: We demonstrated that good recruitment and high retention rates among women living in discordant couple relationships are achievable in this community. The trial is ongoing.
Citation
Kasse, M.J. Recruitment and retention in a vaginal microbicide efficacy trial: experiences with HIV negative women living in discordant couple relationships in rural SW Uganda. Presented at Microbicides 2008, New Delhi, India, 24-27 February 2008. (2008)
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