Effectiveness of Smartphone Application (Vuka+) for Adherence Support in Adolescent Girls and Young Women -Type I Hybrid Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- PrEP adherence
研究概览
简要总结
This is a Type I Hybrid effectiveness-implementation trial to evaluate an HIV Pre-Exposure Prophylaxis (PrEP) medication adherence, persistence and social support app (Vuka+) for adolescent girls and young women (AGYW) in South Africa. This 6-month, 2-arm effectiveness and implementation trial (standard of care [SOC] vs. intervention app) will assess acceptability, feasibility and effectiveness. In addition, we will gather information on intervention delivery and barriers and facilitators for real-world delivery to inform future implementation and scale up.
详细描述
We will recruit 330 AGYW, aged 15-24 from the surrounding community, PrEP clinics and service providers in Cape Town, South Africa. If AGYW qualify for enrollment, they will be offered daily Truvada as PrEP. Participants will then be randomized 1:1 at baseline to SOC counselling and the Vuka+ intervention app or SOC counselling only (control). All participants will receive their regularly scheduled PrEP clinical care visits. At baseline, 1-, 3- and 6-month follow-up visits, participants will complete biobehavioral surveys, undergo HIV testing and pregnancy testing, and provide a urine (month 1 and 6) and DBS sample (months 1, 3 and 6) for tenofovir assessment. Intervention arm participants will also have the following study activities: install the intervention app on their phones at baseline study visit and be asked to use the intervention app for at least 5-10 minutes daily for 6 months. During this time, they will be prompted by the app to complete daily activities or health and wellness readings and to complete a weekly brief assessment related to their PrEP use. At follow-up study visits, intervention arm participants will complete an additional set of questions evaluating their app use experience and a subsample of participants will complete an in-depth qualitative exit interview to assess their app use experience, acceptability of the intervention and their evaluation of the app's content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Assigned female at birth
- •Age 15-24 years
- •Healthy and weight at least 35kg
- •Sexually active (had a male sexual partner in the past 6 months)
- •Consistent access to a smartphone
- •HIV-negative (clinic test)
- •PrEP naive or no PrEP use in the past 6 months
- •Eligible to start oral PrEP
排除标准
- •Unable to currently start PrEP
- •Abnormal laboratory, medical, physical, or social finding which could impact study participation, by investigator discretion
- •Unwilling or unable to provide informed consent
- •Participating in another PrEP trial
- •Unwilling to provide at least 2 forms of contact for follow-up
- •Taking renal toxic medications
- •Sexual partner known to be HIV-positive
结局指标
主要结局
PrEP adherence
时间窗: 3 months
Adherence to PrEP was measured by tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)
次要结局
- Vuka+ app acceptability(6 months)
- Vuka+ app usability(6 months)
