TY - JOUR
T1 - Incentives and Reminders to Improve Long-term Medication Adherence (INMIND)
T2 - Protocol for a Pilot Randomized Controlled Trial
AU - Stecher, Chad
AU - Ghai, Ishita
AU - Lunkuse, Lillian
AU - Wabukala, Peter
AU - Odiit, Mary
AU - Nakanwagi, Agnes
AU - Linnemayr, Sebastian
N1 - Funding Information:
This pilot RCT has been funded by the National Institute of Mental Health in the United States (R34MH122331) and approved by the RAND Corporation’s Human Subjects Protection Committee (2020-N0632), Mildmay Uganda Research Ethics Committee (0701-2021), and Uganda National Council for Science and Technology (HS128ES).
Publisher Copyright:
© 2022 Chad Stecher.
PY - 2022/10
Y1 - 2022/10
N2 - Background: Nonadherence to antiretroviral therapy (ART) among people living with HIV 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increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn. Objective: This study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits. Methods: A sample of 150 participants aged ≥ 18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) 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 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants' anchor during the intervention and during the 6 months after intervention. Results: As of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023. Conclusions: This study is the first to use behavioral economics.based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants' use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process.
AB - Background: Nonadherence to antiretroviral therapy (ART) among people living with HIV 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. Objective: This study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits. Methods: A sample of 150 participants aged ≥ 18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) 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 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants' anchor during the intervention and during the 6 months after intervention. Results: As of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023. Conclusions: This study is the first to use behavioral economics.based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants' use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process.
KW - HIV
KW - antiretroviral therapy
KW - behavioral economics
KW - habit formation
KW - medication adherence
KW - routines
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U2 - 10.2196/42216
DO - 10.2196/42216
M3 - Article
AN - SCOPUS:85142384887
SN - 1929-0748
VL - 11
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 10
M1 - e42216
ER -