Clinical trial NCT06949774: INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)
Official title: INcentives and ReMINDers to Improve Long-term Medication Adherence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Medication Adherence
Habits
Keywords: Behavioral: Daily Text Messages
Behavioral: Incentivization based on
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: National Institute of Mental Health (NIMH)
name: Mildmay Uganda Limited
First posted: 2025-04-29
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: At recruitment, participants will be randomized to one of two low-intensity components (Control or Messages). Those not showing progress towards routinization (defined as pill-taking in line with their anchoring plan on fewer than 80% of days during study month three) will be re-randomized to one of two higher-intensity components (monthly or monthly escalated prizes), ensuring that even participants who do not show routinization progress at month three will have a full three months in the second stage to form a strong ART adherence routine. The second-stage incentives will be given out as prize drawings, as BE shows that they leverage the bias of overestimation of small probabilities and take advantage of the motivational power and joy of games of chance.
Primary purpose: TREATMENT

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.

Detailed description: Building on a previous R34 study, the investigators will adapt and deliver the INMIND approach to 550 ART initiators at Mildmay. Participants will initially be randomized to receive either usual care (Control, n=275) or daily text messages (Messages, n=275) to support adherence routines. At months 1 and 2, participants may revise their adherence plans. Those showing \<80% adherence in month 3 will be re-randomized to receive either monthly or monthly escalated prize incentives for the next three months. Adherence will be monitored for an additional 12 months (total follow-up: 18 months) to assess long-term routine maintenance and recovery after interruptions. The SMART design will help identify the most cost-effective intervention sequencing. A cost-effectiveness analysis and stakeholder dissemination will support future scale-up. The investigators hypothesize that Messages will be more effective than Control as a first-stage treatment; that monthly escalated prizes will be more effective than monthly prizes as a second-stage treatment; and that the mechanisms of lack of Salience and Present Bias will mediate the effect of INMIND on our primary and secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Male and female clients age 18 and older.
* Started ART at Mildmay or another clinic within the preceding 1 month
* 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.

Exclusion Criteria:

* Not mentally fit to consent.
* Language other than Luganda or English.
* Not willing to consistently use the Wisepill device for adherence measurement.

Primary outcomes:
measure: Electronically measured mean medication adherence
timeFrame: 24 months
Secondary outcomes:
measure: Retention in Care.
timeFrame: 24 months
measure: Viral Suppression
timeFrame: 24 months
measure: Routinization of ART adherence
timeFrame: 24 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mildmay Uganda
Study officials:
affiliation: RAND
name: Sebastian Linnemayr, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University
name: Chad Stecher, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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: Linnemayr 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.
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: Jennings 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.
citation: Stecher 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.
citation: Stecher 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.
citation: Lally 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.
citation: Ruppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009 Jun;19(2):167-72. doi: 10.1177/152692480901900211.