Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
2 other identifiers
interventional
50
1 country
1
Brief Summary
The overall goal of this pilot randomized-controlled trial (RCT) is to pilot MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for "Let's empower each other and improve our health"), an ART adherence-supporting smartphone app with 50 adolescents and young adults living with HIV to assess its feasibility and acceptability and to explore preliminary effects on ART adherence and social support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
June 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2024
CompletedResults Posted
Study results publicly available
June 13, 2025
CompletedJune 13, 2025
June 1, 2025
1.7 years
December 4, 2020
March 10, 2025
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Months 1-3
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Months 4-6
Intervention Feasibility: Total Time Participants Spend Using the App
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Months 1-3
Intervention Feasibility: Total Time Participants Spend Using the App
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Months 4-6
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Months 1-3
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Months 4-6
Intervention Acceptability: Composite Score From Adapted System Usability Scale
Acceptability will be measured by an average of participants' scores on an adapted version of the System Usability Scale (SUS), a scale giving a global view of subjective assessments of usability. Total possible range: 0 - 100. Higher score indicates higher usability and helpfulness (better outcome). Average SUS \>68 (average for digital health apps) will be considered acceptable.
3 months
Intervention Acceptability: Composite Score From Adapted System Usability Scale
Acceptability will be measured by an average of participants' scores on an adapted version of the System Usability Scale (SUS), a scale giving a global view of subjective assessments of usability. Total possible range: 0 - 100. Higher score indicates higher usability and helpfulness (better outcome). Average SUS \>68 (average for digital health apps) will be considered acceptable.
6 months
Secondary Outcomes (4)
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
3 months
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
6 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
3 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
6 months
Study Arms (2)
MASI
EXPERIMENTALParticipants 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.
Information-only version of MASI
ACTIVE COMPARATORParticipants randomized to the control condition will an information-only version of MASI which will include the Resources feature and the home page.
Interventions
The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.
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)
The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.
Eligibility Criteria
You may qualify if:
- Age \>= 15 years and \<= 21 years
- 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
You may not qualify if:
- Child dissent despite parent, legal guardian, caregiver informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- University of Cape Towncollaborator
- University of North Carolinacollaborator
- National Institute of Mental Health (NIMH)collaborator
- Florida State Universitycollaborator
Study Sites (1)
University of Cape Town
Cape Town, South Africa
Related Publications (1)
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.
PMID: 37725409DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Marta Mulawa
- Organization
- Duke University School of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Marta I Mulawa, PhD
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2020
First Posted
December 10, 2020
Study Start
June 21, 2022
Primary Completion
March 15, 2024
Study Completion
April 2, 2024
Last Updated
June 13, 2025
Results First Posted
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
The data from this pilot randomized controlled trial will be shared after the publication of the main trial findings within the constraints required for the protection of confidentiality for study subjects. De-identified data will be available through individual requests directed to the Principal Investigator.