INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)
INMIND
1 other identifier
interventional
550
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2025
CompletedFirst Submitted
Initial submission to the registry
April 22, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
September 11, 2025
April 1, 2025
3.8 years
April 22, 2025
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electronically measured mean medication adherence
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 Outcomes (3)
Retention in Care.
24 months
Viral Suppression
24 months
Routinization of ART adherence
24 months
Study Arms (4)
Phase B Stage 1: Control
NO INTERVENTIONThis 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)
EXPERIMENTALThe 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.
Phase B Stage 2: Intervention group receiving messages and incentives (Monthly prize draws)
EXPERIMENTALFirst-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.
Phase B Stage 2: Intervention group receiving messages and incentives (Monthly escalated Prizes)
EXPERIMENTALFirst-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.
Interventions
Participants will receive daily text message reminders to use their routine behavior to trigger medication 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Not mentally fit to consent.
- Language other than Luganda or English.
- Not willing to consistently use the Wisepill device for adherence measurement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
- Arizona State Universitycollaborator
- National Institute of Mental Health (NIMH)collaborator
- Mildmay Uganda Limitedcollaborator
Study Sites (1)
Mildmay Uganda
Kampala, 24985, Uganda
Related Publications (8)
Linnemayr S, Huang H, Luoto J, Kambugu A, Thirumurthy H, Haberer JE, Wagner G, Mukasa B. Text Messaging for Improving Antiretroviral Therapy Adherence: No Effects After 1 Year in a Randomized Controlled Trial Among Adolescents and Young Adults. Am J Public Health. 2017 Dec;107(12):1944-1950. doi: 10.2105/AJPH.2017.304089. Epub 2017 Oct 19.
PMID: 29048966BACKGROUNDLinnemayr S, Stecher C. Behavioral Economics Matters for HIV Research: The Impact of Behavioral Biases on Adherence to Antiretrovirals (ARVs). AIDS Behav. 2015 Nov;19(11):2069-75. doi: 10.1007/s10461-015-1076-0.
PMID: 25987190BACKGROUNDLinnemayr S, Stecher C, Mukasa B. Behavioral economic incentives to improve adherence to antiretroviral medication. AIDS. 2017 Mar 13;31(5):719-726. doi: 10.1097/QAD.0000000000001387.
PMID: 28225450BACKGROUNDJennings Mayo-Wilson L, Devoto B, Coleman J, Mukasa B, Shelton A, MacCarthy S, Saya U, Chemusto H, Linnemayr S. Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda. AIDS Res Ther. 2020 Jun 8;17(1):30. doi: 10.1186/s12981-020-00283-2.
PMID: 32513192BACKGROUNDStecher C, Linnemayr S. Promoting antiretroviral therapy adherence habits: a synthesis of economic and psychological theories of habit formation. AIDS. 2021 Apr 1;35(5):711-716. doi: 10.1097/QAD.0000000000002792. No abstract available.
PMID: 33306553BACKGROUNDStecher C, Mukasa B, Linnemayr S. Uncovering a behavioral strategy for establishing new habits: Evidence from incentives for medication adherence in Uganda. J Health Econ. 2021 May;77:102443. doi: 10.1016/j.jhealeco.2021.102443. Epub 2021 Mar 16.
PMID: 33831632BACKGROUNDLally P, Wardle J, Gardner B. Experiences of habit formation: a qualitative study. Psychol Health Med. 2011 Aug;16(4):484-9. doi: 10.1080/13548506.2011.555774.
PMID: 21749245BACKGROUNDRuppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009 Jun;19(2):167-72. doi: 10.1177/152692480901900211.
PMID: 19588667BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Linnemayr, Ph.D
RAND
- PRINCIPAL INVESTIGATOR
Chad Stecher, Ph.D
Arizona State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Economist; Professor, RAND Pardee Graduate School
Study Record Dates
First Submitted
April 22, 2025
First Posted
April 29, 2025
Study Start
April 2, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
October 31, 2029
Last Updated
September 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- 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.
- 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.
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.