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

September 4, 2025 updated by: Sebastian Linnemayr, RAND

INcentives and ReMINDers to Improve Long-term Medication Adherence

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda, 24985
        • Recruiting
        • Mildmay Uganda
        • Contact:
        • Principal Investigator:
          • Yvonne Karamagi, MB.Ch.B.
        • Sub-Investigator:
          • Mary Odiit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Daily Text Messages
Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
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.
Behavioral: Daily Text Messages
Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
Behavioral: Incentivization based on timely ART adherence
Participants will be eligible to (draw a prize in monthly prize group) or get a monthly prize (monthly escalated group) if they take their medication within +/-one hour of the stated existing routine to which pill-taking is anchored on at least 80% of days for 3-months.
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.
Behavioral: Daily Text Messages
Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
Behavioral: Incentivization based on timely ART adherence
Participants will be eligible to (draw a prize in monthly prize group) or get a monthly prize (monthly escalated group) if they take their medication within +/-one hour of the stated existing routine to which pill-taking is anchored on at least 80% of days for 3-months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electronically measured mean medication adherence
Time Frame: 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)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in Care.
Time Frame: 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.
24 months
Viral Suppression
Time Frame: 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.
24 months
Routinization of ART adherence
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

National Institute of Mental Health (NIMH)
Arizona State University
Mildmay Uganda Limited

Investigators

  • Principal Investigator: Chad Stecher, Ph.D, Arizona State University
  • Principal Investigator: Sebastian Linnemayr, Ph.D, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

October 31, 2029

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH135751 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will produce longitudinal data on a sample of 550 adult (≥18 years old) clients of Mildmay Uganda who started receiving antiretroviral (ART) medications for their HIV infection within the past month. The data will include continuous ART adherence measures over the 24-month study and questionnaires responses. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NIMH Data Archive (NDA) will be collected for each subject. Documentation to be made publicly available to the research community will include a codebook with univariate statistics for each variable and study-level metadata following the Data Documentation Initiative specifications. Each variable in the codebook will include a brief description of the item along with the question number and question text from the questionnaire, variable name, variable label, value labels, and standard codes for missing values.

IPD Sharing Time Frame

All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.

IPD Sharing Access Criteria

To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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