Rewarding Adherence Program - an Intervention Using Small Prizes Allocated by a Prize Drawing to Increase ARV Adherence

Study Overview
=================
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.

Official Title
-----------------
Variable Rewards Incentives for ART Adherence in Uganda

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: Small lottery prizes based on adherence
* Behavioral: Small lottery prizes based on timely clinic visits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prizes conditional on adherence<br>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'. | Behavioral: Small lottery prizes based on adherence<br>* Clients coming for clinic visits have their MEMS data extracted, and if they show 95% adherence or higher are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.<br>|
| Active Comparator: Prizes conditional on clinic visits<br>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'. | Behavioral: Small lottery prizes based on timely clinic visits<br>* Clients coming for clinic visits have their patient booklet checked to confirm that they came on their scheduled day; if so, they are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Event Monitoring System (MEMS) cap measured adherence | Change in adherence over the course of the study | 20 months | 
| Medication Event Monitoring System (MEMS) cap measured adherence | Change in adherence over the first nine months of the study as an interim outcome | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timely clinic visits | Number of timely clinic visits as a fraction of all scheduled clinic visits over the course of the study | 20 months | 
| Self-reported adherence | Adherence level as reported by the patient at month 20 | 20 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARV adherence