Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Case Finding: HIV-positive serostatus
研究概览
简要总结
Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria.
详细描述
Two combination interventions, each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria:
- HIV Case Finding Intervention: single arm trial of an HIV case finding and linkage to care intervention targeting young men at risk of HIV infection (n = 6000), particularly young men who have sex with men (YMSM) in Akwa Ibom, Benue, Enugu, Kano, Taraba, and Lagos states who complete HIV testing.
Objectives: To determine the effectiveness of the intervention to:
- identify youth living with HIV, particularly YMSM and
- link those who test HIV-positive to HIV care
- pre-exposure prophylaxis (PrEP) initiation (uptake) among those who test HIV-negative.
- HIV Treatment Intervention: randomized controlled trial of a medication adherence and viral suppression intervention among youth newly diagnosed with HIV and initiating antiretroviral therapy (ART) for the first time (n = 600) at the participating clinical sites.
Objectives: To determine the effectiveness of the intervention on
- viral suppression and
- adherence to ART
- success of implementation in the target populations
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
- All
- 接受健康志愿者
- 是
入选标准
- •HIV Case Finding Intervention:
- •Aged 15 to 24
- •Male birth sex of any current gender identity
- •Understand basic English, Yoruba, Hausa, Igbo or Pidgin English For the PrEP component, must also be HIV-negative
- •HIV Treatment Intervention:
- •Aged 15 to 24
- •HIV seropositive
- •Initiating ART for the first time at a Clinical Research Performance Site (CRPS) clinic or satellite clinic
- •Understand basic English, Yoruba, Hausa, Igbo or Pidgin English
- •Intention to remain a CRPS patient during follow-up
排除标准
- •Unable to provide consent
- •No parental permission if aged 15 and not emancipated
研究组 & 干预措施
HIV Case Finding Intervention
Combination HIV case finding and linkage to care intervention
干预措施: Testing Peer navigation (Behavioral)
HIV Case Finding Intervention
Combination HIV case finding and linkage to care intervention
干预措施: PrEP Intervention (Behavioral)
HIV Case Finding Intervention
Combination HIV case finding and linkage to care intervention
干预措施: Social Media Outreach (Behavioral)
HIV Treatment Intervention
Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART
干预措施: Treatment Peer Navigation (Behavioral)
HIV Treatment Intervention
Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART
干预措施: SMS Test messaging (Behavioral)
HIV Treatment Intervention
Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART
干预措施: Adherence standard of care (Other)
结局指标
主要结局
Case Finding: HIV-positive serostatus
时间窗: 48 weeks
HIV-positive serostatus based on rapid test with confirmation
Treatment: Viral suppression
时间窗: 48 Weeks
Viral suppression (\< 200 copies per mL)
次要结局
- Case Finding: Linkage to HIV care(48 Weeks)
- Case Finding: PrEP among youth who test HIV-negative(48 weeks)
- Treatment: Adherence to antiretroviral therapy (ART)(48 Weeks)
研究者
Robert Garofalo
Professor
Northwestern University