INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)

Not Applicable

Recruiting

• Conditions: HIV/AIDS; Medication Adherence; Habits

• Registration Number: NCT06949774
• Lead Sponsor: RAND

Brief 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.

Detailed Description

Building on a previous R34 study, the investigators will adapt and deliver the INMIND approach to 550 ART initiators at Mildmay. Participants will initially be randomized to receive either usual care (Control, n=275) or daily text messages (Messages, n=275) to support adherence routines. At months 1 and 2, participants may revise their adherence plans. Those showing \<80% adherence in month 3 will be re-randomized to receive either monthly or monthly escalated prize incentives for the next three months. Adherence will be monitored for an additional 12 months (total follow-up: 18 months) to assess long-term routine maintenance and recovery after interruptions. The SMART design will help identify the most cost-effective intervention sequencing. A cost-effectiveness analysis and stakeholder dissemination will support future scale-up. The investigators hypothesize that Messages will be more effective than Control as a first-stage treatment; that monthly escalated prizes will be more effective than monthly prizes as a second-stage treatment; and that the mechanisms of lack of Salience and Present Bias will mediate the effect of INMIND on our primary and secondary outcomes.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-02
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Study First Posted: 2025-04-29
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2028-12-31
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• Male and female clients age 18 and older.
• Started ART at Mildmay or another clinic within the preceding 1 month
• 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.

Exclusion Criteria

• Not mentally fit to consent.
• Language other than Luganda or English.
• Not willing to consistently use the Wisepill device for adherence measurement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Electronically measured mean medication adherence	24 months	We will collect Wisepill data continuously over the 24-month study period to calculate the primary outcome variable of mean adherence (# of actual bottle openings /# of prescribed bottle openings)

Secondary Outcome Measures

Name	Time	Method
Viral Suppression	24 months	HIV RNA (viral load) is the secondary outcome measure, and we will also examine intervention effects on mean change in log-transformed viral load. Viral loads are now part of routine clinical care in Uganda and will be chart abstracted.
Routinization of ART adherence	24 months	We will calculate the fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking.
Retention in Care.	24 months	Retention in care will be measured as the fraction of participants recruited who are still active clients at the clinic at month 24.

Trial Locations

Locations (1)

Mildmay Uganda; 🇺🇬 Kampala, Uganda