NCT04661878

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 15 Years – 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV Infections
• Adolescent Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-21
• Primary completion: 2024-03-15
• Completion: 2024-04-02
• First posted: 2020-12-10
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

1 site across 1 country: South Africa