Community Engagement in clinical trials Projet Ubuzima experience By Marie Michèle UMULISA
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Transcript of Community Engagement in clinical trials Projet Ubuzima experience By Marie Michèle UMULISA
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 CLOsPROJET UBUZIMA CLOs
Community Health Workers
Community Health Workers
MOBILIZERSMOBILIZERS
Community Advisory GroupCommunity Advisory Group
Local Authorities
Local Authorities PARTICIPANTSPARTICIPANTS
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?