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Alana de Kock, Neetha S. Morar, Nela Williams,
Barbara
Friedland,
Stephanie Skoler,
Vuyelwa Mtimkulu, Veronica Ngcozela, Sicelo Gumede, Vuyelwa
Mehlomakulu, and
Sumentheran N. Govender.
"Engaging participants in a Phase 3 study of the efficacy and safety
of the microbicide CarraguardŽ in preventing HIV seroconversion in
women."
ABSTRACT
Background
Recruiting and retaining sufficient participants adherent to
study product use is imperative for establishing microbicide
efficacy. The Phase 3 trial of CarraguardŽ 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).
Methods
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.
Results
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.
Conclusion
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.
3rd South African AIDS Conference Web site
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