INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial in Uganda (Preprint)

BACKGROUND Nonadherence to antiretroviral therapy (ART) among people living with HIV (PLHIV) is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn. The purpose of this study is to test the feasibility and acceptability of a novel behavioral intervention that uses text messages and behavioral economics (BE)-based incentives to support the anchoring of daily ART pill-taking behavior to an existing routine in order to improve long-term ART adherence. OBJECTIVE To test the feasibility, acceptability, and preliminary efficacy of a novel intervention that utilizes text messages and conditional incentives to support ART initiators in establishing pill-taking habits. METHODS A sample of 150 participants 18 years and older who have initiated ART in the preceding three months will be recruited at Mildmay Uganda in Kampala, Uganda. All participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of three suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Participants will then be randomized to either receive usual care (C = 50) or one of the two interventions delivered over three months: daily text message reminders to follow their chosen anchoring plan (Messages group; T1 = 50) or daily text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (Incentives group; T2 = 50). Long-term ART adherence will be evaluated for six months post intervention, and survey assessments will be conducted at baseline, month 3, and month 9. The outcomes include feasibility and acceptability measures, as well as intervention efficacy outcomes defined by 1) electronically measured mean medication adherence during the intervention and 2) during the six months post intervention, along with 3) a measure of routine ART adherence based on taking medications around the time of participants’ anchor during the intervention and 4) during the six months post intervention. RESULTS This pilot RCT was funded by the National Institutes of Mental Health in the United States (R34MH122331), and approved by the RAND Human’s Subjects Protection Committee (2020-N0632), Mildmay Uganda Research Ethics Committee (MUREC) (0701-2021), as well as the Uganda National Council for Science and Technology (HS128ES). As of February 18, 2022, recruitment was completed. CONCLUSIONS This study is the first to employ BE-based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. The results of this pilot RCT will help to refine this combined intervention approach for testing at scale, and will broaden our understanding of the habit formation process. CLINICALTRIAL Clinicaltrials.gov, NCT05131165. Retrospectively registered on 12 November 2021.