Clinical trial NCT05131165: INcentives and ReMINDers to Improve Long-term Medication Adherence
Official title: INcentives and ReMINDers to Improve Long-term Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: ART Adherence
Reminders
Behavioral Economics
Viral Suppression
Long-term Adherence
Routines
Habit Formation
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Mildmay Uganda Limited
name: Arizona State University
First posted: 2021-11-23
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized controlled trial with two intervention arms and a control group, that will receive intervention for three months with follow-on assessment for six months after the intervention period ends.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3)
timeFrame: Three months
measure: Proportion of Pills Taken as Prescribed Over the Post-intervention Period (Months 4-9)
timeFrame: Six months post-intervention
measure: Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Intervention Period (Baseline - Month 3)
timeFrame: Three months
measure: Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Post-Intervention Period (Months 4-9)
timeFrame: Six months post-intervention
Secondary outcomes:
measure: Retention in Care
timeFrame: Month 9
measure: Change in Viral Suppression Status
timeFrame: Month 9
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mildmay Uganda Limited
Study officials:
affiliation: RAND
name: Sebastian Linnemayr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Linnemayr 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.
citation: 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.
citation: Stecher 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.