Recruitment and reasons for drop-out on feasibility study - Zambia.

TEXT Background: Effective recruitment and retention strategies are crucial in the multi-centre-clinical trail being conducted by Microbicides Development Programme (MDP). The aim of the trial to determine clinical efficacy of vaginal Microbicides. One of the objectives of the feasibility study was to assess the level of recruitment and retention of women. Methodology: Women were invited to participate in an 18 months feasibility study from a Zambia sugar population. The community mobilization methods used included, door-to-door, Radio programmes, Public Address system and Raffle draw. Study information was provided through health talks before being screened and enrolled into the study. Study information sheets and consent forms were administered to the women who needed to understand that they were undergo an HIV and syphilis test every three months, they would to be asked personal questions about their sexual practices including condom use and that they would undergo a pelvic examination every six months before they decided to join the study. Results: The target number that was to be recruited was 750. A total of 1145 women aged 18-45 years in regular sexual relationships were screened and 606 were enrolled into the study and there was a shortfall of 144 women (19.2%) who were not recruited to meet the target. The retention rate was about 80% among the participants that were enrolled. Altogether,123 (20.3%) of the participants dropped-out and the reasons for this were; husband refused them to continue 9 (7.3%), relocated due to retirement 17 (13.8%), gave wrong address 20 (16.3%), clients were not willing to continue 11(8.9%), women did not complete the enrolment procedures 10 (8.1%), refused speculum 4 (3.3%), wrongly recruited 1(0.8%), not willing to be retested 2 (1.6%), lost to follow 45(36.6%) and no reasons 4 (3.3%). Conclusion: The community mobilization methods that were used during the feasibility were effective in the recruitment and retention of participants in the study. Retention rate could have been improved if participants’ physical addresses follow-up was done before enrolment. Mrs Catherine Sitali Counsellor: Microbicides Development Programme, cathysitali@yahoo.co.uk, tel +260 3 230834, fax +260 3 230868, MDP Zambia, Box 670555, Mazabuka, MAZABUKA, 10101, ZAMBIA