Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 541
- 试验地点
- 6
- 主要终点
- VIral suppression
研究概览
简要总结
Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.
详细描述
A randomized stepped wedge (cluster) trial will be conducted to investigate a combination interventions (with mHealth + Peer Navigation components) among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. The Treatment Intervention will test a combination intervention that targets HIV treatment outcomes (retention, adherence and viral suppression).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Living with HIV infection
- •Registered in the study clinics or their satellite clinics
- •On antiretroviral therapy (ART) for at least 3 months
- •Intention to remain a study clinic patient during the study observation and intervention period
排除标准
- •Inability to provide informed consent
- •Youths who are 15 years old and not emancipated, who do not have parental consent
研究组 & 干预措施
Sequence A (Cluster 1): HIV Treatment Intervention
0 to 48 weeks intervention, 49-72 weeks post-intervention
干预措施: Peer navigation (Behavioral)
Sequence A (Cluster 1): HIV Treatment Intervention
0 to 48 weeks intervention, 49-72 weeks post-intervention
干预措施: SMS Text messaging (Behavioral)
Sequence B (Cluster 2): HIV Treatment Intervention
0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention
干预措施: Peer navigation (Behavioral)
Sequence B (Cluster 2): HIV Treatment Intervention
0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention
干预措施: SMS Text messaging (Behavioral)
Sequence C (Cluster 3): HIV Treatment Intervention
0 to 48 weeks pre-intervention, 49 - 96 weeks intervention
干预措施: Peer navigation (Behavioral)
Sequence C (Cluster 3): HIV Treatment Intervention
0 to 48 weeks pre-intervention, 49 - 96 weeks intervention
干预措施: SMS Text messaging (Behavioral)
结局指标
主要结局
VIral suppression
时间窗: Week 48
Proportion of participants with viral suppression, defined as viral load (plasma HIV-1 RNA) \<200 copies/ml
Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml)
时间窗: Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequence 1 (intervention at visit 1=0 weeks(at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline)
We assessed the change in proportion of participants who were virally suppressed before and after exposure to 48 weeks of the iCARE intervention.
Proportion With Virologic Suppression (HIV-1 RNA<200 Copies mL)
时间窗: 24 Week Period
Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA \<200 copies/ml); 24 Week Period
Proportion With Viral Load Suppression (HIV RNA <200 Copies/ml)
时间窗: 48 Week Period
Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA \<200 copies/ml); 48 Week Period
次要结局
- Antiretrovial adherence measured by pharmacy drug pick-up(Week 48)
- Antiretroviral drug concentration(Week 48)
- Retention in care(Week 48)
- Proportion of Participants With Antiretrovial Adherence(Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequences 1 (intervention at visit 1=0 weeks (at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline))
- Proportion of Participants With Antiretroviral Adherence(24 Week period)
- Proportion of Participants With Antiretroviral Adherence >=90%(48 Week Period)
研究者
Babafemi Taiwo
Professor
Northwestern University