PC82 Supporting the Trial: The use of behavioral and social science (BSS) methods for recruitment, retention, and monitoring community concerns
ElizabethTolley, LawrenceSevery, ArwenBunce, FerdinandMito-Yobo, AbdramaneBerthe, Sethulakshmi, StellaNeema, CynthiaWoodsong, AmyCorneli, LutVan Damme
ABSTRACT TEXT
Background:
Phase III Microbicide trials face daunting challenges. In each site, staff must recruit sufficient numbers of trial participants who correspond to eligibility criteria within a limited recruitment period. Once enrolled, participants must remain in the trial for 12 months and comply with a number of behavioral expectations, including frequent clinic visits, gel, condom and sometimes contraceptive use. As difficulties within several recent HIV-prevention trials have demonstrated, concerns within the immediate geographic community, as well as national or international health policy and advocacy communities, can bring clinical trials to a standstill.
Methods:
BSS research was conducted in four of five sites prior to initiation of CONRAD’s Phase III Effectiveness Trial of 6% Cellulose Sulfate (CS). (Activities are planned for the sixth site.) Across these sites, 112 in-depth interviews and 30 focus group discussions with a range of community opinion leaders (COLs) and potential participants (PPs), self-declared sex workers and women with multiple sexual partners, were conducted in order to identify factors likely to affect recruitment, retention and adherence of trial participants; investigate community understanding of and attitudes towards the microbicide trial; and develop strategies to support successful implementation of the trial.
Results:
Across professional and cultural settings, women cited similar motivations for participating in a microbicide trial, including altruism, access to healthcare and, less frequently, monetary gain. Particularly for women with high-risk behaviors, such incentives were counter-balanced by concerns about associated stigma, potential side effects, and negative partner reactions. Factors affecting adherence differed by sexual context and cultural setting. For example, self-declared sex workers in West African sites often used lubricants with condoms, whereas most women in India were unfamiliar with vaginal product use. Certain aspects of the clinical trial, such as randomization, reason for using a placebo, or determination of product effectiveness, were difficult for both COLs and PPS to understand, and many times, difficult for interviewers to explain.
Conclusion:
This research informed the development of enhanced strategies to reach high-risk women and provided useful information on how to more clearly communicate aspects of the microbicide trial.
Dr.ElizabethTolley - Scientist: Family Health International, , tel 001/919-544-7040, 2224 E NC Highway 54, DURHAM, NC, 27713, USA