Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
NCT ID: NCT04661878
Last Updated: 2025-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-06-21
2024-04-02
Brief Summary
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Detailed Description
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We developed MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for "Let's empower each other and improve our health"), an ART adherence-supporting smartphone app for AYAHIV in South Africa. MASI was culturally adapted to the South African context using the evidence based HealthMpowerment platform. HealthMpowerment is a smartphone app-based intervention originally developed by Dr. Lisa Hightow-Weidman, and was developed based on the Institute of Medicine's Integrated Behavior Model with extensive input from youth. The app is designed to foster social support, offer tools for self-monitoring and habit formation, provide resources for goal setting and action planning, and present users with engaging informational resources.
This pilot randomized-controlled trial (RCT) is funded through a K01 Mentored Research Scientist Development Award. Prior to the pilot RCT, the study team developed and customized MASI through in-depth interviews and beta-testing with adolescents living with HIV in Cape Town. For the pilot RCT, participants will be randomized to either the full version of the MASI app or an information-only version of MASI control condition (1:1, with stratification by gender). Participants will be asked to engage with MASI for 6 months. All participants will complete baseline and follow-up assessments at 3- and 6-months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MASI
Participants randomized to the intervention condition will receive access to MASI, the smartphone app customized for this study. MASI is an adapted version of HealthMpowerment, a theory-based smartphone app with features including an anonymous interactive discussion forum, a medication and adherence tracker, a platform to ask questions to an expert, a section with engaging activities (including quizzes, self-assessments, and goal-setting activities), and a multi-media resource center.
Social Support
The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.
Informational Resources
The app will provide opportunities for participants to review HIV-related health information in engaging formats (e.g., activities, multi-media resources, and answer to users' health questions)
Self-Monitoring and habit formation
The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
Goal setting and action planning
The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.
Information-only version of MASI
Participants randomized to the control condition will an information-only version of MASI which will include the Resources feature and the home page.
Informational Resources
The app will provide opportunities for participants to review HIV-related health information in engaging formats (e.g., activities, multi-media resources, and answer to users' health questions)
Interventions
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Social Support
The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.
Informational Resources
The app will provide opportunities for participants to review HIV-related health information in engaging formats (e.g., activities, multi-media resources, and answer to users' health questions)
Self-Monitoring and habit formation
The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
Goal setting and action planning
The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.
Eligibility Criteria
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Inclusion Criteria
* Knows HIV status (Screened adolescents who do not know their HIV status will receive information on free voluntary HIV counseling and testing services)
* Living with HIV
* Has been prescribed medication to treat HIV
* Not attending school for learners with special needs (e.g., School of Skills)
* Has not repeated a grade in school more than once
* Has a smartphone that can download apps
* Feels comfortable using an app with content in English
* No plan to move outside of Cape Town in the next six months
* Has not previously participated in the MASI app testing phase of our study
* Able to successfully install the MASI app on their smartphone
* Child dissent despite parent, legal guardian, caregiver informed consent
15 Years
21 Years
ALL
No
Sponsors
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University of Cape Town
OTHER
University of North Carolina
OTHER
National Institute of Mental Health (NIMH)
NIH
Florida State University
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Marta I Mulawa, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of Cape Town
Cape Town, , South Africa
Countries
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References
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Mulawa MI, Hoare J, Knippler ET, Mtukushe B, Matiwane M, Muessig KE, Al-Mujtaba M, Wilkinson TH, Platt A, Egger JR, Hightow-Weidman LB. MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 19;12:e47137. doi: 10.2196/47137.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00103309
Identifier Type: -
Identifier Source: org_study_id
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