Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Failure to meet any of the inclusion criteria
- •Child dissent despite parent, legal guardian, caregiver informed consent
结局指标
主要结局
Intervention Feasibility: Number of Days Participants Log in to the App as Recorded by App Backend Paradata
时间窗: Months 4-6
Feasibility will be measured by the number days participants log in to the app as recorded by app backend paradata
Intervention Feasibility: Total Time Participants Spend Using the App
时间窗: Months 4-6
Feasibility will be measured by the total time, in minutes, participants spend using app as recorded by app backend paradata.
Intervention Feasibility: Number of Days Participants Log Medications Using the App as Recorded by App Backend Paradata
时间窗: Months 4-6
Feasibility will be measured by the number of days participants log medications in the app as recorded by app backend paradata.
Intervention Acceptability: Composite Score From Adapted System Usability Scale
时间窗: 6 months
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.
次要结局
- Adherence to ART, as Measured by 30-day Recall of Days With Missed ART Doses(6 months)
- Perceived Social Support and Social Isolation Using Adapted Medical Outcomes Study Social Support Survey (MOS-SS)(6 months)