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mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot
Yerina S Ranjit1, Archana Krishnan, Debarchana Ghosh2
1Department of Communication, University of Missouri, Columbia, MO, United States.
Insights
This study tested a mobile health intervention using smart pillboxes and smartphones to improve medication adherence for people with HIV who use cocaine. The intervention aimed to overcome challenges in engaging high-risk populations in HIV care.
Area of Science:
- Digital health interventions
- HIV/AIDS research
- Substance use disorder treatment
Background:
- Antiretroviral therapy (ART) is crucial for managing HIV, but adherence is challenging, especially for individuals with substance use disorders.
- People with HIV who use cocaine often face barriers to consistent HIV care and lower retention rates.
- Improving medication adherence is critical for successful HIV treatment outcomes and reducing transmission.
Purpose of the Study:
- To describe a mobile health (mHealth) intervention designed to enhance ART adherence among people with HIV who use cocaine.
- To identify and discuss challenges and adaptations in the study design for this population.
- To provide insights into implementing complex mHealth interventions for marginalized groups.
Main Methods:
- Project SMART utilized a 12-week pilot randomized controlled trial with a wireless technology-based intervention.
- Intervention components included cellular-enabled electronic pillboxes (TowerView Health) and smartphones for adherence reminders and feedback.
- The study design was informed by Self-Determination Theory and the Motivation Technology Model, incorporating automated, clinician-assisted, and social network feedback arms.
Main Results:
- The study enrolled 71 participants, with 80% (57) completing the 12-week intervention.
- Data collection occurred between June 2017 and January 2020.
- Full study results are currently undergoing analysis, with publication anticipated in early 2022.
Conclusions:
- Implementing mHealth interventions for high-risk populations presents significant challenges, including technological access, financial stability, and minimizing participant burden.
- Feasibility studies are essential for identifying and addressing these challenges proactively.
- Adapting intervention designs to maintain the integrity of randomized controlled trials is crucial for generating reliable evidence.
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.
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