NCT02503072

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

July 14, 2015

Last Update Submit

September 27, 2016

Conditions

HIV

Keywords

ARV adherence

Outcome Measures

Primary Outcomes (2)

  • Medication Event Monitoring System (MEMS) cap measured adherence

    Change in adherence over the course of the study

    20 months

  • 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

Secondary Outcomes (2)

  • Timely clinic visits

    20 months

  • Self-reported adherence

    20 months

Study Arms (2)

Prizes conditional on adherence

ACTIVE COMPARATOR

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

Prizes conditional on clinic visits

ACTIVE COMPARATOR

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

Interventions

Small lottery prizes based on adherenceBEHAVIORAL

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.

Prizes conditional on adherence
Small lottery prizes based on timely clinic visitsBEHAVIORAL

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.

Prizes conditional on clinic visits

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mildmay Uganda

Kampala, Uganda

Location

Related Publications (3)

  • 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.

    PMID: 33831632DERIVED

  • 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.

    PMID: 31813077DERIVED

  • 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.

    PMID: 28225450DERIVED

Study Officials

  • Sebastian Linnemayr, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 20, 2015

Study Start

March 1, 2013

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

UG(1)