INcentives and ReMINDers to Improve Long-term Medication Adherence
INMIND
1 other identifier
interventional
166
1 country
1
Brief Summary
The study will test the feasibility and acceptability of using text messages and behavioral economics-based incentives to support anchoring Anti-Retroviral Therapy (ART) adherence to an existing routine in order to improve long-term ART medication adherence. The intervention phase of the three-phased study will constitute the pilot RCT. A sample of 150 clients who have initiated ART in the preceding three months will be randomized to either usual care (C = 50) or one of the two INMIND intervention groups (daily text message reminders with or without incentives) for three months (T1 = 50; T2=50). Subsequently, behavioral persistence will be evaluated for six months post-intervention. Assessments will be conducted at baseline, month 3, and month 9. The primary outcomes are 1) electronically measured mean medication adherence during the intervention and 2) six months post intervention, along with 3) timeliness of medication adherence during the intervention and 4) six months post-intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2021
CompletedFirst Submitted
Initial submission to the registry
November 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedApril 13, 2025
September 1, 2024
1.8 years
November 12, 2021
June 21, 2024
April 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3)
MEMS-data was collected continuously over the course of the three-month intervention period allowing us to investigate mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Three months
Proportion of Pills Taken as Prescribed Over the Post-intervention Period (Months 4-9)
MEMS-data was collected continuously over the course of the six-month post intervention period allowing for the investigation of post-intervention mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Six months post-intervention
Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Intervention Period (Baseline - Month 3)
A novel measure of routine adherence (that it is explicitly based on the temporal pattern of pill-taking), calculated as 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, was calculated. This measure provides an objective way for determining behavioral automaticity of pill-taking.
Three months
Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Post-Intervention Period (Months 4-9)
This measure would be calculated as a 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, for all visits made post-intervention.
Six months post-intervention
Secondary Outcomes (2)
Retention in Care
Month 9
Change in Viral Suppression Status
Month 9
Study Arms (3)
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 regularly routine behavior that occurs at roughly the same time each day that forms the basis of their implementation plan.
Intervention group receiving messages (Messages Group)
EXPERIMENTALParticipants will receive the same information as those in the Control Group, but in addition, receive the "Daily Text Message" Intervention.
Intervention group receiving messages and incentives (Incentives Group)
EXPERIMENTALParticipants will receive the same information as the Control group. Additionally, they will receive the "Daily Text Message Intervention" and will be eligible for prize drawings.
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 if they take their medication within +/- one hour of the stated existing routine to which pill-taking is anchored on at least 70% of days between recruitment and the 3-month study visit.
Eligibility Criteria
You may qualify if:
- Male and female clients age 18 and older.
- Started ART at Mildmay or another clinic within the preceding three months but have since been receiving care at Mildmay.
- 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 3 months of intervention duration.
- Willing and able to use the MEMS caps 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 MEMS caps device for adherence measurement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
- National Institute of Mental Health (NIMH)collaborator
- Mildmay Uganda Limitedcollaborator
- Arizona State Universitycollaborator
Study Sites (1)
Mildmay Uganda Limited
Kampala, Uganda
Related Publications (11)
Ruppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009 Jun;19(2):167-72. doi: 10.1177/152692480901900211.
PMID: 19588667BACKGROUNDPhillips LA, Gardner B. Habitual exercise instigation (vs. execution) predicts healthy adults' exercise frequency. Health Psychol. 2016 Jan;35(1):69-77. doi: 10.1037/hea0000249. Epub 2015 Jul 6.
PMID: 26148187BACKGROUNDLally 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: 21749245BACKGROUNDStecher 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: 33831632BACKGROUNDStecher 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: 33306553BACKGROUNDJennings 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: 32513192BACKGROUNDLinnemayr 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: 28225450BACKGROUNDLinnemayr 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, Odiit M, Mukasa B, Ghai I, Stecher C. INcentives and ReMINDers to Improve Long-Term Medication Adherence (INMIND): impact of a pilot randomized controlled trial in a large HIV clinic in Uganda. J Int AIDS Soc. 2024 Jun;27(6):e26306. doi: 10.1002/jia2.26306.
PMID: 38923298DERIVEDStecher C, Ghai I, Lunkuse L, Wabukala P, Odiit M, Nakanwagi A, Linnemayr S. Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 31;11(10):e42216. doi: 10.2196/42216.
PMID: 36315224DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations consist of our statistical analysis being based on a small pilot study that was not powered for all outcomes. Also, the intervention took place in a single HIV clinic in Uganda, but we believe the intervention site (and hence our results) to be fairly representative of many urban clinics in sub-Saharan Africa.
Results Point of Contact
- Title
- Sebastian Linnemayr
- Organization
- RAND Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Linnemayr, Ph.D.
RAND
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigator and outcomes assessor will be blinded to treatment assignment of study participants.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2021
First Posted
November 23, 2021
Study Start
October 25, 2021
Primary Completion
August 23, 2023
Study Completion
August 23, 2023
Last Updated
April 13, 2025
Results First Posted
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Will be decided after consultation with the RAND Human Subjects Protection Committee.
- Access Criteria
- Access will be allowed post-registration, wherein accessing individuals will need to completed a data sharing agreement that outlines the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. The data sharing agreement will include a commitment to using the data only for research purposes, a commitment to securing the data using appropriate computer technology, and a commitment to destroying or returning the data after analyses are completed. Users must submit brief proposals regarding intended use of the data; the study team will determine the scientific soundness of the proposal as part of the decision for the researcher to be able to access the public use dataset.
Data collected in the execution of the aims described in the application will be shared in the form of journal publications. Following publication of the main paper(s) for this study and the grant end-date, the RAND Human Subjects Protection Committee will be consulted about how to securely make data publicly available in the form of an electronic database for researchers who successfully complete a registration process (described below). Any shared data will be de-identified and will not contain any direct identifiers or indirect identifiers (that could identify participants by inference). No qualitative data will be shared, as such data would be difficult to de-identify given that participants will be telling their own experiences and thus could be identified by inference. Documentation of shared data will be provided in the form of a codebook in which each variable name and response options are defined.