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

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Duke University

Status

Completed

Conditions

HIV Infections
Adolescent Behavior

Treatments

Behavioral: Social Support
Behavioral: Self-Monitoring and habit formation
Behavioral: Goal setting and action planning
Behavioral: Informational Resources

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04661878
K01MH118072 (U.S. NIH Grant/Contract)
Pro00103309

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

15 to 21 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

MASI
Experimental group
Description:
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.
Treatment:
Behavioral: Informational Resources
Behavioral: Goal setting and action planning
Behavioral: Self-Monitoring and habit formation
Behavioral: Social Support
Information-only version of MASI
Active Comparator group
Description:
Participants randomized to the control condition will an information-only version of MASI which will include the Resources feature and the home page.
Treatment:
Behavioral: Informational Resources

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Marta I Mulawa, PhD

Data sourced from clinicaltrials.gov

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