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

HIV Clinical Trial

— RAP  

Official title:

Variable Rewards Incentives for ART Adherence in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503072
• Other study ID #: 1R34MH096609-01A1
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: September 27, 2016
• Start date: March 2013
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Small lottery prizes based on adherence
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.
• Small lottery prizes based on timely clinic visits
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.

Locations

Country	Name	City	State
Uganda	Mildmay Uganda	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
RAND	Mildmay Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Event Monitoring System (MEMS) cap measured adherence	Change in adherence over the course of the study	20 months	No
Primary	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	No
Secondary	Timely clinic visits	Number of timely clinic visits as a fraction of all scheduled clinic visits over the course of the study	20 months	No
Secondary	Self-reported adherence	Adherence level as reported by the patient at month 20	20 months	No