Rewarding Adherence Program - an Intervention Using Small Prizes Allocated by a Prize Drawing to Increase ARV Adherence
- Conditions
- HIV
- Interventions
- Behavioral: Small lottery prizes based on adherenceBehavioral: Small lottery prizes based on timely clinic visits
- Registration Number
- NCT02503072
- Lead Sponsor
- RAND
- Brief Summary
The goal of this study is to identify ways for implementing small prizes allocated by a drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala, Uganda. The study is called Rewarding Adherence Program (RAP).
- Detailed Description
The proposed 3-year study will develop and test RAP for incentivizing ART clients to remain engaged in care and highly adherent to their medication. Phase 1 of the project will consist of focus groups with patients, clinic providers and directors, and community leaders and will elicit information on barriers and facilitators of long-term retention and adherence maintenance, how to best implement the intervention to ensure acceptability and feasibility, and perceptions of the transportability of the planned intervention. Parameters of the intervention that will be probed include the frequency, type, and value of the prizes, and award presentation. Phase 2 will build on Phase 1 to develop and pilot test the RAP in a 20 months long randomized controlled trial (RCT) among clients who have been on ART for at least 2 years and have problems with missed clinic appointments or ART doses. Primary assessments will be administered at screening and months 4, 8, 14 and 20. In Phase 3 some adjustments to the intervention will be made after reviewing Phase 2 data, if needed, and then the intervention will be administered to the control group for 6 months to assess effects on adherence in this group (the original intervention group will not participate in this phase). Finally, the investigators will conduct focus groups with providers, implementers, and study participants to learn about implementation difficulties and areas for future improvement. Study findings will directly inform the design parameters of a larger, more rigorous evaluation in an R01 application that will focus on the cost-effectiveness and sustainability of the intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- patient at Mildmay Kampala clinic
- on antiretroviral medication (ARV) for at least two years
- shows recent adherence problems (missing a clinic visit or pharmacy refill in the last six months)
- not able to understand study procedures and/or provide informed consent
- not fluent in either English or Luganda (the two main languages spoken around Kampala)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prizes conditional on adherence Small lottery prizes based on adherence Participants in this group are eligible for a prize drawing if they come on their scheduled clinic day. They receive the intervention 'Behavioral: Small lottery prizes based on adherence'. Prizes conditional on clinic visits Small lottery prizes based on timely clinic visits Participants in this group are eligible for a prize drawing if they show 95% adherence or higher based on their MEMS-cap measured adherence. They receive the intervention 'Behavioral: Small lottery prizes based on timely clinic visits'.
- Primary Outcome Measures
Name Time Method Medication Event Monitoring System (MEMS) cap measured adherence 9 months Change in adherence over the first nine months of the study as an interim outcome
- Secondary Outcome Measures
Name Time Method Timely clinic visits 20 months Number of timely clinic visits as a fraction of all scheduled clinic visits over the course of the study
Self-reported adherence 20 months Adherence level as reported by the patient at month 20
Trial Locations
- Locations (1)
Mildmay Uganda
πΊπ¬Kampala, Uganda