Clinical trial NCT04661878: Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
Official title: Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Adolescent Behavior
Keywords: mobile health
adolescent
HIV
South Africa
social network
adherence
treatment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: University of North Carolina
name: National Institute of Mental Health (NIMH)
name: Florida State University
First posted: 2020-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
timeFrame: Months 1-3
measure: Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
timeFrame: Months 4-6
measure: Intervention Feasibility: Total Time Participants Spend Using the App
timeFrame: Months 1-3
measure: Intervention Feasibility: Total Time Participants Spend Using the App
timeFrame: Months 4-6
measure: Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
timeFrame: Months 1-3
measure: Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
timeFrame: Months 4-6
measure: Intervention Acceptability: Composite Score From Adapted System Usability Scale
timeFrame: 3 months
measure: Intervention Acceptability: Composite Score From Adapted System Usability Scale
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
timeFrame: 3 months
measure: Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
timeFrame: 6 months
measure: Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
timeFrame: 3 months
measure: Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: Duke University
name: Marta I Mulawa, PhD
role: PRINCIPAL_INVESTIGATOR
References: