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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661878
• Other study ID #: Pro00103309
• Secondary ID: K01MH118072
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: April 2, 2024

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Florida State University, National Institute of Mental Health (NIMH), University of Cape Town, University of North Carolina

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months, 6 months
Primary	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.	3 months, 6 months
Primary	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.	3 months, 6 months
Primary	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.	3 months, 6 months
Secondary	Adherence to ART, as measured by 30-day recall of missed doses	Adherence to antiretroviral therapy will be measured using the participant's self-reported number of missed ART doses in the past 30 days.	3 months
Secondary	Adherence to ART, as measured by 30-day recall of missed doses	Adherence to antiretroviral therapy will be measured using the participant's self-reported number of missed ART doses in the past 30 days.	6 months
Secondary	Perceived social support and social isolation using adapted Medical Outcomes Study Social Support Survey (MOS-SS)	Perceived social 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. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).	3 months
Secondary	Perceived social support and social isolation using adapted Medical Outcomes Study Social Support Survey (MOS-SS)	Perceived social 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. Total possible range: 12 - 48. Higher score indicates higher social support (better outcome).	6 months