Community-informed trial design and implementation to optimize recruitment and retention in low-income settings: lessons from rheumatic heart disease trials in Uganda - Summary - MDSpire
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Community-informed trial design and implementation to optimize recruitment and retention in low-income settings: lessons from rheumatic heart disease trials in Uganda
To address challenges in conducting randomized clinical trials for rheumatic heart disease (RHD) in low-income areas by implementing a community-centered framework.
Approach:
Community Engagement: Utilized 'community engagement studios' and a Community Advisory Board for ongoing consultation and feedback throughout the trial.
Trial Design: Developed a flexible trial design that incorporates community input to enhance participant recruitment and retention.
GOAL-family Studies: Applied community-informed approaches in the GOAL-family of studies to improve care for children with early RHD.
Key Findings:
Achieved consent rates over 99% and retention rates over 97% at trial completion.
Demonstrated over 99% adherence to monthly injections in the GOAL trial.
Community-informed strategies effectively addressed barriers to trial participation in low-resource settings.
Interpretation:
The RRCU's community-informed approach challenges assumptions about research feasibility in low-resource settings and shows that ethical pediatric research can be conducted successfully by engaging communities.
Limitations:
The study's findings may not be generalizable to all low-income settings due to specific cultural and contextual factors in Uganda.
Limited infrastructure and resources in LMICs may still pose challenges despite community engagement efforts.
Conclusion:
The community-centered framework can serve as a model for enhancing recruitment and retention in clinical trials across various diseases in low-income areas.
