Engaging participants in a Phase 3 study of the efficacy and safety of the microbicide Carraguard® in preventing HIV seroconversion in women
Presentation at 3rd South African AIDS Conference, Durban, 5-8 June
de Kock,Alana; Morar,Neetha S.; Williams,Nela; Friedland,Barbara A.; Skoler,Stephanie; Mtimkulu,Vuyelwa; Ngcozela,Veronica; Gumede,Sicelo; Mehlomakulu,Vuyelwa; Govender,Sumentheran N.
Publication date: 2007
Recruiting and retaining sufficient participants adherent to study product use is imperative for establishing microbicide efficacy. The Phase 3 trial of Carraguard® enrolled 6,203 women over 27 months in three South African sites: Gugulethu (University of Cape Town), Soshanguve (University of Limpopo/Medunsa campus), and Isipingo (Medical Research Council).
Informing trial communities and establishing formal links, such as Community Advisory Groups, before trial commencement ensured interaction between the research populations and researchers. Community representatives assisted with developing study materials (including the study booklet and video) and with establishing relationships with relevant organizations for recruitment and remained engaged throughout the study. Many retention strategies were used, including media advertising, group information sessions, and road shows. For retention and adherence, study staff encouraged participants to update contact information and communicate with study counselors regarding participation issues. Staff engaged with participants via telephone between visits and for missed visits implemented follow-up procedures. Complex administrative systems ensured that follow-up and documentation occurred. The sites worked together sharing strategies and challenges.
Challenges posed by recruitment and retention included: ulterior motives for study participation, uncooperative male partners, lack of product use, and pregnancies. Intersite workshops were held and the cross-pollination of information, despite different contexts and demographic profiles, enhanced the sites' abilities to successfully recruit, retain, and improve the adherence of participants.
Community involvement and a good understanding of research population issues that affect implementation of microbicide trials are important for ensuring cohorts for complex and lengthy trials. Continually assessing and adapting procedures is imperative for optimal recruitment, retention, and adherence.
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