Clinical trial NCT02503072: Rewarding Adherence Program - an Intervention Using Small Prizes Allocated by a Prize Drawing to Increase ARV Adherence
Official title: Variable Rewards Incentives for ART Adherence in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: ARV adherence
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Mildmay Uganda Limited
First posted: 2015-07-20
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Medication Event Monitoring System (MEMS) cap measured adherence
timeFrame: 20 months
measure: Medication Event Monitoring System (MEMS) cap measured adherence
timeFrame: 9 months
Secondary outcomes:
measure: Timely clinic visits
timeFrame: 20 months
measure: Self-reported adherence
timeFrame: 20 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mildmay Uganda
Study officials:
affiliation: RAND
name: Sebastian Linnemayr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stecher C, Mukasa B, Linnemayr S. Uncovering a behavioral strategy for establishing new habits: Evidence from incentives for medication adherence in Uganda. J Health Econ. 2021 May;77:102443. doi: 10.1016/j.jhealeco.2021.102443. Epub 2021 Mar 16.
citation: Wagner GJ, Ghosh-Dastidar B, Mukasa B, Linnemayr S. Changes in ART Adherence Relate to Changes in depression as Well! Evidence for the Bi-directional Longitudinal Relationship Between Depression and ART Adherence from a Prospective Study of HIV Clients in Uganda. AIDS Behav. 2020 Jun;24(6):1816-1824. doi: 10.1007/s10461-019-02754-8.
citation: Linnemayr S, Stecher C, Mukasa B. Behavioral economic incentives to improve adherence to antiretroviral medication. AIDS. 2017 Mar 13;31(5):719-726. doi: 10.1097/QAD.0000000000001387.