INcentives and ReMINDers to Improve Long-term Medication Adherence

HIV/AIDS Clinical Trial

— INMIND  

Official title:

INcentives and ReMINDers to Improve Long-term Medication Adherence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05131165
• Other study ID #: R34MH122331
• Secondary ID: R34MH122331
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 166
• Est. completion date: August 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Daily Text Messages
Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
• 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.

Locations

Country	Name	City	State
Uganda	Mildmay Uganda Limited	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
RAND	Arizona State University, Mildmay Uganda Limited, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Phillips 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. — View Citation

Ruppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009 Jun;19(2):167-72. doi: 10.1177/152692480901900211. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electronically measured mean medication adherence during intervention	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
Primary	Electronically measured mean medication adherence 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
Primary	Routinization of ART adherence during intervention	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
Primary	Routinization of ART adherence 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	Retention in care	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
Secondary	Viral Suppression	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