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

RanD

Status: Enrolling

Conditions: Habits; Medication Adherence; HIV/AIDS

Treatments: Behavioral: Daily Text Messages; Behavioral: Incentivization based on timely ART adherence

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06949774

R01MH135751 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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550 participants in 4 patient groups

Phase B Stage 1: Control

No Intervention group

Description:

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.

Phase B Stage 1: Intervention group receiving messages (Messages group)

Experimental group

Description:

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.

Treatment:

Behavioral: Daily Text Messages

Phase B Stage 2: Intervention group receiving messages and incentives (Monthly prize draws)

Experimental group

Description:

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.

Treatment:

Behavioral: Incentivization based on timely ART adherence

Behavioral: Daily Text Messages

Phase B Stage 2: Intervention group receiving messages and incentives (Monthly escalated Prizes)

Experimental group

Description:

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.

Treatment:

Behavioral: Incentivization based on timely ART adherence

Behavioral: Daily Text Messages