Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 12
- 主要终点
- Peer navigation - viral suppression (effectiveness)
研究概览
简要总结
This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.
详细描述
This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months.
In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18-24 months in two 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV.
The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation.
The study duration is two years (about 5-7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 12 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 12 - <19, at enrolment
- •Living with HIV
- •Aware of their HIV status
- •Receiving ART for at least six months
- •Able to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
- •Willing and able to consent to study activities
- •Willing and able to get parental consent for study activities
- •(Stage 1, objective 2 only) Age ≥ 18 years and Caregiver of an adolescent with HIV
- •(Stage 1, objective 2 only) Age ≥ 18 years and provides clinical services or is a policy maker involved in adolescents with HIV
排除标准
- •Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
- •Severe mental or physical illness preventing participation in informed consent activities.
研究组 & 干预措施
Peer navigation effectiveness
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
干预措施: Peer navigation effectiveness (Behavioral)
结局指标
主要结局
Peer navigation - viral suppression (effectiveness)
时间窗: 18 months
To determine the effectiveness of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL \<50 copies/ml) over 18 months.
Peer navigation - retention in care (effectiveness)
时间窗: 18 months
To determine the effectiveness of peer navigation on retention among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) over 18 months.
次要结局
- Peer navigation - viral suppression (sustainability)(36 months)
- Peer navigation - retention (sustainability)(36 months)
- long-acting injectable ART - acceptability(36 months)
- Economic evaluation analysis of providing LAI(36 months)
- Economic evaluation analysis of providing peer navigation(36 months)
- Cost-effectiveness analyses of providing LAI(36 months)
- Cost-effectiveness analyses of providing peer navigation(36 months)