Strategies used to refocus recruitment efforts to higher risk subgroups during a vaginal microbicide study in Mwanza, Tanzania.
OBJECTIVE: To describe strategies used to increase the proportion of higher risk women enrolled in a Microbicides Development Programme (MDP) vaginal microbicide study in Mwanza, Tanzania. METHODS: Recruitment into a randomised clinical trial to assess the effectiveness of a vaginal microbicide, PRO 2000/5, in Mwanza is via invitation through a community liaison system established in a preceding feasibility study. In order to increase the proportion of “higher risk” women (identified during feasibility study as bar workers and guest house workers), meetings were conducted in the 10 wards in which the recruitment facilities were represented involving representatives of trial participants. Participatory methodologies (such as Participatory Rapid Assessment) were used to facilitate the process of identification of factors preventing the women working in bars from joining the clinical trial. The exercise helped to identify that stigmatization within the community and workplace generated fear of HIV testing among women. Also bar working hours coincide with the clinic's working days, resulting in reluctance of bar managers to allow employees the time to attend the clinical trial clinics. RESULTS: Through the community liaison system and use of participatory approaches, barriers to recruitment of high-risk women were identified. Strategies to address these barriers were initiated in August 2007, including meetings with bar managers to improve their understanding of the nature and purpose of the study and to facilitate arrangements that would enable bar workers to take the time off necessary to attend the study clinic. Intensified counselling regarding the benefits of HIV testing to reduce fear and stigma was provided. The proportion of bar workers screened increased between July and September from 12.9% (12/ 93) to 37.5 %( 18/48). CONCLUSION: Addressing the concerns of potential participants and engaging other stakeholders are essential when developing and refining recruitment strategies for an HIV prevention clinical trial.
Concilia, J. Strategies used to refocus recruitment efforts to higher risk subgroups during a vaginal microbicide study in Mwanza, Tanzania. Presented at Microbicides 2008, New Delhi, India, 24-27 February 2008. (2008)