Challenges with participant reimbursement: experiences from a post-trial access study

Area of Science:

• Clinical Trials
• Implementation Science
• Public Health

Background:

• Participant reimbursement in clinical trials lacks clear guidance, particularly for studies integrating post-trial access and implementation science.
• The CAPRISA 008 study aimed to implement a pre-licensure HIV prevention intervention using family planning services, balancing research needs with standard care.

Purpose of the Study:

• To evaluate the impact of reimbursement adjustments on participant accrual, retention, and morale in a combined post-trial access and implementation science study.
• To update institutional policies based on South African National Health Research Ethics Committee guidelines for participant reimbursement.

Main Methods:

• A post-trial access study (CAPRISA 008) tested an HIV prevention intervention rollout.
• Initially offered reduced reimbursement for standard of care visits, which negatively impacted study metrics.
• Reviewed guidelines and updated institutional policy to increase reimbursement for standard care visits, considering participant time, travel, and inconvenience.

Main Results:

• Reduced reimbursement for standard care visits negatively affected participant accrual, retention, and morale.
• Increased costs of living and travel delays exacerbated these issues.
• Adjusting reimbursement based on updated guidelines led to improvements in study metrics.

Conclusions:

• Participant reimbursement strategies require careful consideration, especially in complex trials.
• Adjusting reimbursement for standard care visits can positively influence trial outcomes.
• Further discussion is needed on appropriate reimbursement levels for trials offering direct participant benefits and above-standard care.