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

Variable Rewards Incentives for ART Adherence in Uganda

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02503072
Acronym
RAP
Enrollment
157
Registered
2015-07-20
Start date
2013-03-31
Completion date
2016-03-31
Last updated
2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

ARV adherence

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.

Interventions

BEHAVIORALSmall 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.

BEHAVIORALSmall 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.

Sponsors

Mildmay Uganda Limited
CollaboratorOTHER
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Medication Event Monitoring System (MEMS) cap measured adherence20 monthsChange in adherence over the course of the study

Secondary

MeasureTime frameDescription
Timely clinic visits20 monthsNumber of timely clinic visits as a fraction of all scheduled clinic visits over the course of the study
Self-reported adherence20 monthsAdherence level as reported by the patient at month 20

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026