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Completed

NCT Number: NCT05131165

INcentives and ReMINDers to Improve Long-term Medication Adherence

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mildmay Uganda Limited

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily Text Messages

Behavioral

Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.

Incentivization based on timely ART adherence

Behavioral

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.

Primary outcomes

  1. Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3)

    Time frame: Three months

    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).

  2. Proportion of Pills Taken as Prescribed Over the Post-intervention Period (Months 4-9)

    Time frame: Six months post-intervention

    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).

  3. Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Intervention Period (Baseline - Month 3)

    Time frame: Three months

    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.

  4. Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Post-Intervention Period (Months 4-9)

    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.

Secondary outcomes

  1. Retention in Care

    Time frame: Month 9

    Retention in care was measured as the fraction of participants recruited who are still active clients at the clinic at month 9.

  2. Change in Viral Suppression Status

    Time frame: Month 9

    HIV RNA (viral load) was the secondary outcome measure. For each participant, viral loads taken just prior to baseline and viral loads taken just after month-9 were compared; if participant was virally suppressed (with < 200 copies of HIV per millilitre (mL) of blood) at baseline, but had a viral load of >= 200 copies/mL after month-9, then the indicator was assigned "-1"; if there was no change in viral suppression status (i.e., if participant either had >= 200 copies of virus/mL at baseline and month-9 OR if participant had < 200 copies/mL at baseline and month-9), then the indicator was assigned "0". If, however, the participant's viral load went from >= 200 copies/mL at baseline to < 200 copies/mL after month-9, then the indicator was assigned "1".

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

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

Registry information

Acronym: INMIND

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2021
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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