Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adolescent Behavior
  • HIV Infections
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 14 years and 21 years
Gender
Both males and females

Description

Interventions that engage adolescents living with HIV to improve adherence to antiretroviral therapy (ART) are urgently needed. Adolescents repeatedly demonstrate suboptimal adherence to ART, which is associated with increased morbidity and mortality. Developing adherence-promoting interventions for...

Interventions that engage adolescents living with HIV to improve adherence to antiretroviral therapy (ART) are urgently needed. Adolescents repeatedly demonstrate suboptimal adherence to ART, which is associated with increased morbidity and mortality. Developing adherence-promoting interventions for adolescents requires an understanding of factors that shape adherence from multiple levels. Developmental theories suggest that adolescents 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. This study will customize HealthMpowerment, a smartphone app-based (Android and iOS) intervention originally developed by Dr. Lisa Hightow-Weidman, to improve ART adherence among South African adolescents living with HIV. HealthMpowerment 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 will iteratively customize the HealthMpowerment app through in-depth interviews and focus group discussions with adolescents living with HIV in Cape Town. For the pilot RCT, participants will be randomized to either the intervention or control (standard of care) condition (1:1). Participants randomized to the intervention will be asked to engage with the app for 6 months. All participants will complete baseline and follow-up assessments at 3- and 6-months.

Tracking Information

NCT #
NCT04661878
Collaborators
  • University of Cape Town
  • University of North Carolina
  • National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Marta I Mulawa, PhD Duke University