INcentives and ReMINDers to Improve Long-term Medication Adherence

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male and female clients age 18 and older.

• Started ART at Mildmay or another clinic within the preceding 2 months

• Able to speak and understand either English or Luganda.

• Have their own cell phone or have consistent access to someone else's phone.

• Willing to receive daily text messages for the 6 months of intervention duration.

• Willing and able to use the WisePill device distributed for adherence verification for the duration of the study.

Locations
Other Locations
Uganda
Mildmay Uganda
RECRUITING
Kampala
Contact Information
Primary
Yvonne Karamagi Site Principal Investigator
yvonne.karamagi@mildmay.or.ug
+256312210200
Backup
Lillian Lukuse
lillianlunkuse@gmail.com
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 550
Treatments
No_intervention: Phase B Stage 1: Control
This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices. At recruitment participant will be explained the importance of pill-taking. All participants (including in the control group) will receive a leaflet containing detailed information on how to establish healthy pill-taking routines. Finally, clinic staff will counsel participants on how to select an already existing routine behavior that occurs at roughly the same time each day that forms the basis of their implementation plan.
Experimental: Phase B Stage 1: Intervention group receiving messages (Messages group)
The Messages group will receive the same brief information session as the Control group but also receive daily text messages reinforcing the information provided at the recruitment visit and reminders of their personalized routinization strategy.
Experimental: Phase B Stage 2: Intervention group receiving messages and incentives (Monthly prize draws)
First-stage non-responders will be re-randomized to the monthly prize draw group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills within one hour of the time, they carry out their existing routine as stated in their anchoring plan for at least 80% of the days in that month. The prizes at each monthly drawing will be worth 1,000; 5,000; or 10,000 Uganda Shillings. Participants who were receiving messages will continue to receive messages as before.
Experimental: Phase B Stage 2: Intervention group receiving messages and incentives (Monthly escalated Prizes)
First-stage non-responders will be re-randomized to the monthly escalating prizes group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills for at least 80% of the days in that month. In the first month, the prize will be worth 1,000 Uganda Shillings. If they are consistent, the prize amount will increase to 5,000 Uganda Shillings in the second month and 10,000 Uganda Shillings in the third month. However, if they do not achieve the 80% adherence level, they will be reset to only receive 1,000 Uganda Shillings in that month. Participants in this group who have been receiving messages will continue to receive messages as before.
Related Therapeutic Areas
Sponsors
Collaborators: Arizona State University, National Institute of Mental Health (NIMH), Mildmay Uganda Limited
Leads: RAND

This content was sourced from clinicaltrials.gov