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ACTIVE NOT RECRUITING
NCT05378607
NA

Goals for Adherence with Low-cost Incentives

Sponsor: RAND

View on ClinicalTrials.gov

Summary

GOALS is a three-year randomized control trial (RCT) aimed at testing the effectiveness of three incentive designs to improve the ART adherence of those in need of adherence support. Participants in the first treatment group (T1, n=140) will be eligible for a prize drawing every three months if they reach the adherence target set for them by the study team, gradually increasing from their baseline adherence towards 90% by the end of the year. Participants in the second treatment group (T2, n=140) will be eligible if they reach the adherence target they set for themselves (subject to reaching 90% at the end of year 1 and each target being at least as high as the previous one). Participants in the third treatment group will have a fixed adherence target of 90% and will be eligible for a prize drawing every three months if this target is reached. All treatment groups will receive weekly motivational messages and a reminder of the upcoming prize drawing. The control group (T4, n=140) will receive the usual standard of care offered by the hospital and weekly motivational messages. Primary outcomes measured using Wisepill devices are mean ART adherence and the fraction of clients with adherence of 90% or more. Secondary outcomes are viral suppression, the fraction of clients with treatment interruptions of 48hrs or more, and retention in care.

Key Details

Gender

All

Age Range

15 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

560

Start Date

2022-04-18

Completion Date

2027-08-11

Last Updated

2025-03-27

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Incentivization based on gradually increasing, externally chosen adherence goals

Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000, or 10,000 Ugandan Shillings if adherence matches or exceeds the subgoal chosen by the study coordinator. Subgoals will gradually increase from the participant's baseline adherence up to 90%. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.

BEHAVIORAL

End of year 1 adherence prize drawing

Participants will have a chance to participate in a prize drawing at the end of year 1 with larger prize amounts of up to 20,000 Ugandan Shillings (approximately $6), where eligibility is based on reaching 90% in the three months preceding the end of year 1.

BEHAVIORAL

SMS motivational messages + reminder of prize drawing

Participants will receive weekly motivational messages with a reminder of their upcoming prize drawing throughout year 1 of the study.

BEHAVIORAL

Year 2 re-allocation based on year 1 performance

In Year 2 of the study, participants who have reached 90% by the end of year 1 will no longer be given sub-goals and instead will be eligible for prize drawings if they maintain the fixed level of 90% or higher. Those who have not reached 90% by the end of year 1 will be allocated to the intervention group that showed the highest effectiveness in year 1.

BEHAVIORAL

End of Year 2 viral suppression prize drawing

Participants will have a chance to participate in a prize drawing at the end of Year 2 with larger prize amounts of up to 20,000 Ugandan Shillings (approximately $6), where eligibility is based on achieving viral suppression by the end of Year 2.

BEHAVIORAL

Incentivization based on gradually increasing self-chosen adherence goals

Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000, or 10,000 Ugandan Shillings if adherence matches or exceeds the self-chosen subgoal. While self-chosen, subgoals are subject to a minimum threshold determined by baseline adherence working towards 90% adherence. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.

BEHAVIORAL

Incentivization based on a fixed adherence goal

Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000 or 10,000 Ugandan Shillings if adherence matches or exceeds the fixed adherence goal of 90%. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.

BEHAVIORAL

SMS motivational messages

The control group will also receive weekly motivational messages but without the reminder of the upcoming prize drawing.

Locations (1)

Mildmay Uganda

Kampala, Uganda