This report documents behavioral and social science (BSS) activities carried out by Family Health International (FHI) and its partners from September 2004 through August 2007 in support of CONRAD's Phase III clinical trial to determine the effectiveness of cellulose sulfate 6% (Ushercell) in preventing transmission of HIV.
Some or all BSS activities were implemented during three phases (Preparedness, On-Going, and Exit) in seven sites, including Cotonou, Benin; Bobo-Dioulassa, Burkina Faso; Kampala, Uganda; Durban, South Africa; Chennai and Bagalkot, India; and Kinshasa, Zimbabwe. The objectives of the BSS work were to:
- Advise on data collection instruments and techniques, including informed consent materials and process
- Identify and develop strategies affecting both recruitment and retention
- Examine community understanding of and attitudes toward trial; develop and implement strategies to improve community support
- Document referral medical care sites identified for individuals who seroconvert, or who test HIV positive at screening
- Explore former participants' understanding of and adherence to trial requirements, including study gel use
- Assess how communities, trial staff, and participants understand the decision to terminate the trial
Research findings show the importance of utilizing BSS activities to enhance the implementation of HIV prevention clinical trials. Some of the topic areas where major findings and recommendations were made include:
- Promoting understanding of clinical trials
- Recruiting and retaining trial participants
- Gel acceptability and adherence
- Planning for early closure
