ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02503072
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : September 29, 2016
Sponsor:
Collaborator:
Mildmay Uganda
Information provided by (Responsible Party):
RAND

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).

Condition or disease Intervention/treatment Phase
HIV Behavioral: Small lottery prizes based on adherence Behavioral: Small lottery prizes based on timely clinic visits Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Variable Rewards Incentives for ART Adherence in Uganda
Study Start Date : March 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Prizes conditional on adherence
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
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.

Active Comparator: Prizes conditional on clinic visits
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
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503072


Locations
Uganda
Mildmay Uganda
Kampala, Uganda
Sponsors and Collaborators
RAND
Mildmay Uganda
Investigators
Principal Investigator: Sebastian Linnemayr, PhD RAND

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT02503072     History of Changes
Other Study ID Numbers: 1R34MH096609-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by RAND:
ARV adherence