PMID- 35254270 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220409 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 11 IP - 3 DP - 2022 Mar 7 TI - mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial. PG - e28332 LID - 10.2196/28332 [doi] LID - e28332 AB - BACKGROUND: Antiretroviral therapy is effective in reducing HIV-related morbidity, mortality, and transmission among people with HIV. However, adherence and persistence to antiretroviral therapy are crucial for successful HIV treatment outcomes. People with HIV who use cocaine have poor access to HIV services and lower retention in care. OBJECTIVE: The primary goal of this paper is to provide a detailed description of a mobile health intervention. This study is designed to improve medication adherence among people with HIV who use cocaine. A secondary goal is to list the important challenges and adaptations incorporated in the study design. METHODS: This study, titled Project SMART, used a wireless technology-based intervention, including cellular-enabled electronic pillboxes called TowerView Health and smartphones, to provide reminders and feedback on adherence behavior. The intervention design was based on the theoretical frameworks provided by the self-determination theory and the Motivation Technology Model. The 12-week pilot randomized controlled trial with four arms provided three types of feedback: automated feedback, automated+clinician feedback, and automated feedback+social network feedback. RESULTS: The study was funded by the National Institute of Drug Abuse (R21DA039842) on August 1, 2016. The institutional review board for the study was approved by Yale University on March 21, 2017. Data collection lasted from June 2017 to January 2020. The final enrollment was 71 participants, of whom 57 (80%) completed the study. The data are currently undergoing analysis, and the manuscript is being developed for publication in early 2022. CONCLUSIONS: Implementing complex mobile health interventions for high-risk and marginalized populations with multicomponent interventions poses certain challenges, such as finding companies with adequate technology for clients and financial stability and minimizing the research-related burden for the study population. Conducting feasibility studies is important to recognize these challenges and the opportunity to address these challenges with solutions while keeping the design of a randomized controlled trial as true as possible. TRIAL REGISTRATION: Clinicaltrials.gov NCT04418076; https://clinicaltrials.gov/ct2/show/NCT04418076. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28332. CI - (c)Yerina S Ranjit, Archana Krishnan, Debarchana Ghosh, Claire Cravero, Xin Zhou, Frederick L Altice. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.03.2022. FAU - Ranjit, Yerina S AU - Ranjit YS AUID- ORCID: 0000-0002-4361-7508 AD - Department of Communication, University of Missouri, Columbia, MO, United States. FAU - Krishnan, Archana AU - Krishnan A AUID- ORCID: 0000-0001-6021-7736 FAU - Ghosh, Debarchana AU - Ghosh D AUID- ORCID: 0000-0002-9181-1524 AD - Department of Geography, University of Connecticut, Storrs, CT, United States. FAU - Cravero, Claire AU - Cravero C AUID- ORCID: 0000-0002-0590-5920 AD - Harvard T H Chan School of Public Health, Harvard University, Boston, MA, United States. FAU - Zhou, Xin AU - Zhou X AUID- ORCID: 0000-0003-2852-1468 AD - Department of Internal Medicine, Section of Infectious Diseases, Yale University, New Haven, CT, United States. FAU - Altice, Frederick L AU - Altice FL AUID- ORCID: 0000-0002-7860-693X AD - Department of Internal Medicine, Section of Infectious Diseases, Yale University, New Haven, CT, United States. LA - eng SI - ClinicalTrials.gov/NCT04418076 GR - UL1 TR001863/TR/NCATS NIH HHS/United States PT - Journal Article DEP - 20220307 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 EIN - JMIR Res Protoc. 2022 Apr 7;11(4):e37925. doi: 10.2196/37925. PMID: 35389873 PMC - PMC8938831 OTO - NOTNLM OT - antiretroviral therapy OT - cocaine use OT - description of feasibility and acceptability OT - mHealth intervention OT - mobile phone OT - people with HIV OT - smart pillbox OT - smartphone COIS- Conflicts of Interest: FLA declares the following conflicts of interest, which are unrelated to this research: research grant support to Yale University where he is listed as principal investigator or co-principal investigator (National Institute of Health, National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, Health Resources and Services Administration, Substance Abuse and Mental Health Services Administration, Gilead Foundation, Merck Pharmaceuticals); Speakers Bureau (Gilead Sciences, Practice Point Communications Simply Speaking HIV, Clinical Care Options); and Advisory Board Membership (Abbvie, Gilead Sciences, Alliance for Patient Access). EDAT- 2022/03/08 06:00 MHDA- 2022/03/08 06:01 PMCR- 2022/03/07 CRDT- 2022/03/07 12:16 PHST- 2021/03/01 00:00 [received] PHST- 2021/11/22 00:00 [accepted] PHST- 2021/07/07 00:00 [revised] PHST- 2022/03/07 12:16 [entrez] PHST- 2022/03/08 06:00 [pubmed] PHST- 2022/03/08 06:01 [medline] PHST- 2022/03/07 00:00 [pmc-release] AID - v11i3e28332 [pii] AID - 10.2196/28332 [doi] PST - epublish SO - JMIR Res Protoc. 2022 Mar 7;11(3):e28332. doi: 10.2196/28332.