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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.
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)
The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
University of Cape Town
Cape Town, South Africa
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Time frame: Months 1-3
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Time frame: Months 4-6
Intervention Feasibility: Total Time Participants Spend Using the App
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Time frame: Months 1-3
Intervention Feasibility: Total Time Participants Spend Using the App
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Time frame: Months 4-6
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Time frame: Months 1-3
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Time frame: Months 4-6
Intervention Acceptability: Composite Score From Adapted System Usability Scale
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.
Acceptability will be measured by an average of participants' scores on an adapted version of the System Usability Scale (SUS), a scale giving a global view of subjective assessments of usability. Total possible range: 0 - 100. Higher score indicates higher usability and helpfulness (better outcome). Average SUS \>68 (average for digital health apps) will be considered acceptable.
Time frame: 3 months
Intervention Acceptability: Composite Score From Adapted System Usability Scale
Acceptability will be measured by an average of participants' scores on an adapted version of the System Usability Scale (SUS), a scale giving a global view of subjective assessments of usability. Total possible range: 0 - 100. Higher score indicates higher usability and helpfulness (better outcome). Average SUS \>68 (average for digital health apps) will be considered acceptable.
Time frame: 6 months
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
Adherence to antiretroviral therapy will be measured using the participant's self-reported number of days with missed ART doses in the past 30 days. "Thinking about the past month (30 days) on how many days did you miss taking your treatment? "
Time frame: 3 months
Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses
Adherence to antiretroviral therapy will be measured using the participant's self-reported number of days with missed ART doses in the past 30 days. "Thinking about the past month (30 days) on how many days did you miss taking your treatment? "
Time frame: 6 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
Perceived social support will be measured using an adapted version of the Medical Outcomes Study Social Support Survey (MOS-SS), which measures four domains of social support: emotional/informational support, tangible support, affectionate support, and positive social interaction. Outcome reported is sum of the 12 items. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).
Time frame: 3 months
Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)
Perceived social support will be measured using an adapted version of the Medical Outcomes Study Social Support Survey (MOS-SS), which measures four domains of social support: emotional/informational support, tangible support, affectionate support, and positive social interaction. Outcome reported is sum of the 12 items. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).
Time frame: 6 months