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

Sponsor
Duke University
Study ID
NCT04661878
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Social Support — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
  • Goal setting and action planning — BEHAVIORAL
    The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.

Study Details

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.

Key Dates

Start date
Jun 21, 2022
Status verified
Jun 2025
Primary completion
Mar 15, 2024
Completion
Apr 2, 2024

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata [ Time Frame: Months 1-3 ]

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