Community Engagement in clinical trials Projet Ubuzima experience By Marie Michèle UMULISA Community Outreach & Recruitment Manager, Projet Ubuzima

Presentation outline Why do community engagement? Project Ubuzima Community outreach group and partners Participant recruitment and retention Challenges and achievements Way forward

Why do community engagement? Build trust in the community around trials Provide best information possible to all stakeholders and potential study participants Build research literacy and support for microbicide studies, participants, future access to product Educate / inform / update / acknowledge

Projet Ubuzima Non-profit organization established 2004 Objective to reduce spread of HIV/AIDS Completed HIV incidence study in Kigali 800 sex workers - one time HIV test 400 cohort participants - followed up for 1 year Additional 1250 women - recruited through VCTs 13 community advisory groups and 8 mobilizers identified via NGOs and local administrators

Objectives of community outreach Encourage and facilitate community support and participation in Projet Ubuzima activities Strategically disseminate information about microbicide products in communities Assess issues and develop strategies related to the acceptability of vaginal microbicides Maximize recruitment and retention of study participants

The community outreach group Well-respected persons from the community identified and briefed (local church leaders, administrators, women’s rights advocates, etc.) Community Advisory Group (CAG) formed with representatives from 6 grassroots institutions, plus traditional healers, former study participants Community Mobilizers come from the local administrative entity - UMUDUGUDU (village)

Training for CAG members Clinical research and microbicide trials Good Clinical Practice (GCP) Research ethics HIV/AIDS STIs and family planning

Role of community mobilizers Help with recruitment and follow up of participants Provide information and advice about rumors, misconceptions, concerns from community Organize meetings in the community as needed

Information exchange PROJET UBUZIMA CLOs Community Health Workers MOBILIZERS Community Advisory Group Local Authorities PARTICIPANTS

Participant recruitment & retention Good retention & adherence begins with quality recruitment Pre-selection of participants done by community outreach team and mobilizers Study procedures / visits conducted by PU staff Participants who miss appointments are contacted by the outreach team and mobilizers to discuss reasons

Challenges Rotation of local authorities Need more qualified trainers on research tools, methodologies and activities Communities often suspicious about the research - more education needed Fear of speculum examinations Reluctance to have blood drawn frequently Socio-cultural factors, taboos, misconceptions

Achievements Successful recruitment for HIV incidence studies High retention rate of approximately 96% Strong collaboration and partnership at all levels of local government and civil society organizations Excellent collaboration with the media in disseminating information to the community High-level symposium on microbicides raised awareness among policy makers & opinion leaders Good collaboration with other research programs

Way forward Microbicide clinical studies planned in 2009: IPM 014 (gel) and IPM 015 (ring) Goal to improve community engagement, understanding and participation in research Develop innovative strategies Educate communities on the importance of research Continue training of CAG and mobilizers Increase national and international contacts and exchange of best practices

Acknowledgments Projet Ubuzima colleagues Our study participants Rwanda Ministry of Health CAG members Community mobilizers Local authorities Media

Questions?