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

July 14, 2023 updated by: RAND
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Adherence of Anti-Retroviral Therapy (ART) among HIV-infected patients initiating treatment (treatment initiators) in Sub-Saharan Africa has remained low, even though the number of treatment initiators has increased in recent years. Lack of retention in care and low adherence in the first year of ART treatment are substantial barriers to virologic suppression. The current R34 study tests a novel approach for improving long-term ART adherence among treatment initiators by turning adherence into a behavioral routine. This is done in two ways: 1) anchoring ART adherence to an existing routine, and 2) providing more immediate rewards and increasing the salience through reminder messages. Insights from behavioral economics suggest that such an intervention may be particularly effective for people with present bias (those who have a tendency to give in to short-term temptation at the cost of more long-term benefits) and lack of salience (where over time, the choice of target behavior is overshadowed by more pressing needs of daily life) which have been found to be prevalent among people living with chronic medical conditions from past studies.

The intervention will be tested through a pilot RCT, wherein 150 adult clients will be randomly assigned to three groups. The first intervention group would receive daily text messages that reinforce routine formation information provided to all participants (across the three groups). The second intervention group will receive the text messages, and additionally be eligible for a prize drawing based on timely ART adherence, at each monthly clinic visit. The control group will receive care as usual, consisting of routine formation information as well as adherence counseling. The intervention will last three months, with a six-month post-intervention follow up period. All participants will receive MEMS caps to record adherence, and will complete assessments over nine months (baseline, post-intervention, and six months post-intervention).

The Specific Aim of the intervention phase of the study is to test the preliminary effectiveness of the intervention, including the relative effectiveness of the two different implementation approaches. This is preceded by the formative phase, with the Specific Aim of developing the intervention parameters. The intervention phase is succeeded by the adaptation phase, whose Specific Aim is to collect data in preparation for a subsequent R01 application.

Study Type

Interventional

Enrollment (Actual)

166

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 Locations

  • Uganda
      • Kampala, Uganda
        • Mildmay Uganda Limited

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

18 years and older (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 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.

Exclusion Criteria:

  • Not mentally fit to consent.
  • Language other than Luganda or English.
  • Not willing to consistently use the MEMS caps 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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 regularly routine behavior that occurs at roughly the same time each day that forms the basis of their implementation plan.
Experimental: Intervention group receiving messages (Messages Group)
Participants will receive the same information as those in the Control Group, but in addition, receive the "Daily Text Message" Intervention.
Behavioral: Daily Text Messages
Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
Experimental: Intervention group receiving messages and incentives (Incentives Group)
Participants 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electronically measured mean medication adherence during intervention
Time Frame: Three months
MEMS-data will be collected continuously over the course of the three-month intervention period allowing us to investigate mean adherence. Only one of the ART medications will be used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Three months
Electronically measured mean medication adherence post intervention
Time Frame: Six months post-intervention
MEMS-data will be 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 will be used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Six months post-intervention
Routinization of ART adherence during intervention
Time Frame: Three months
A novel measure of routine adherence (that it is explicitly based on the temporal pattern of pill-taking) will be used. It is 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. This measure provides an objective way for determining behavioral automaticity of pill-taking.
Three months
Routinization of ART adherence post-intervention
Time Frame: Six months post-intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in care
Time Frame: Month 9
Retention in care will be measured as the fraction of participants recruited who are still active clients at the clinic at month 9.
Month 9
Viral Suppression
Time Frame: Month 9
HIV RNA (viral load) is the secondary outcome measure, and the investigators 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.
Month 9

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: 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)

October 25, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH122331 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Will be decided after consultation with the RAND Human Subjects Protection Committee.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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