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Completed

NCT Number: NCT02503072

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

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).

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mildmay Uganda

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Small lottery prizes based on adherence

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Medication Event Monitoring System (MEMS) cap measured adherence

    Time frame: 20 months

    Change in adherence over the course of the study

  2. Medication Event Monitoring System (MEMS) cap measured adherence

    Time frame: 9 months

    Change in adherence over the first nine months of the study as an interim outcome

Secondary outcomes

  1. Timely clinic visits

    Time frame: 20 months

    Number of timely clinic visits as a fraction of all scheduled clinic visits over the course of the study

  2. Self-reported adherence

    Time frame: 20 months

    Adherence level as reported by the patient at month 20

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Mildmay Uganda Limited

Registry information

Official study title

Variable Rewards Incentives for ART Adherence in Uganda

Acronym: RAP

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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