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| Funder | Wellcome Trust |
|---|---|
| Recipient Organization | Ifakara Health Institute |
| Country | United Kingdom |
| Start Date | Apr 01, 2021 |
| End Date | Mar 31, 2025 |
| Duration | 1,460 days |
| Number of Grantees | 1 |
| Roles | Award Holder |
| Data Source | Europe PMC |
| Grant ID | 222636 |
Community engagement is an essential component in clinical trials, and it is regarded as an ethical requirement of most ethics review committees before the trial protocols can be approved.
However, there is a scarcity of studies that have objectively assessed the impact of best engagement practices on recruitment and retention rates.
Using an in-depth review of the literature, in-depth interviews, and focus group discussions with relevant stakeholders, we will develop clinical trial community engagement best practices.
We will then establish and pilot an implementation assessment tool that would be used to assess the extent of implementation of these practices.
Finally, we will conduct a randomized controlled study to assess the efficacy of best practices on the recruitment and retention rates of clinical trials in a randomized controlled trial, where trials in the intervention arm will be assigned to implement the new best practices, and control trials will implement their originally planned engagement approaches.
The implementation assessment tool will be used to measure the extent of adherence to the newly established best practices in both arms.
We will then assess the enhancers and barriers to the successful implementation of clinical trial best community engagement practices.
Ifakara Health Institute
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