Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Adolescent Behavior
• Intervention / Treatment: Behavioral: Social Support; Behavioral: Informational Resources; Behavioral: Self-Monitoring and habit formation; Behavioral: Goal setting and action planning

Detailed Description

Interventions that engage adolescents and young adults with HIV (AYAHIV) to improve adherence to antiretroviral therapy (ART) are urgently needed. AYAHIV repeatedly demonstrate suboptimal adherence to ART, which is associated with increased morbidity and mortality. Developing adherence-promoting interventions for AYAHIV requires an understanding of factors that shape adherence from multiple levels. Developmental theories suggest that adolescents and young adults are particularly sensitive to their social networks. Mobile health (mHealth) interventions, those that use mobile technology (e.g., smartphones apps) to transmit health information, hold promise as an effective way to improve ART adherence. These smartphone apps can be used to engage social networks and provide social support. Access to mobile phone technology is rapidly increasing among youth in South Africa, making mHealth interventions feasible and potentially scalable in this setting.

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • University of Cape Town

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Failure to meet any of the inclusion criteria
• Child dissent despite parent, legal guardian, caregiver informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: 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); Behavioral: Self-Monitoring and habit formation; The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.; Behavioral: 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.
Active Comparator: 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.	Behavioral: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses	Adherence to antiretroviral therapy will be measured using the participant's self-reported number of days with missed ART doses in the past 30 days. "Thinking about the past month (30 days) on how many days did you miss taking your treatment? "	3 months
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses	Adherence to antiretroviral therapy will be measured using the participant's self-reported number of days with missed ART doses in the past 30 days. "Thinking about the past month (30 days) on how many days did you miss taking your treatment? "	6 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)	Perceived social support will be measured using an adapted version of the Medical Outcomes Study Social Support Survey (MOS-SS), which measures four domains of social support: emotional/informational support, tangible support, affectionate support, and positive social interaction. Outcome reported is sum of the 12 items. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).	3 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)	Perceived social support will be measured using an adapted version of the Medical Outcomes Study Social Support Survey (MOS-SS), which measures four domains of social support: emotional/informational support, tangible support, affectionate support, and positive social interaction. Outcome reported is sum of the 12 items. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).	6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH); Florida State University; University of Cape Town; University of North Carolina
• Investigators: Principal Investigator: Marta I Mulawa, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: treatment; HIV; adolescent; adherence; mobile health; South Africa; social network
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: Pro00103309; K01MH118072 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No