Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
试验速览
- 阶段
- 不适用
- 入组人数
- 216
- 试验地点
- 5
- 主要终点
- Retention in care in care 6 months post-transfer
研究概览
简要总结
The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.
详细描述
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of ACT, a coordinated protocol for transitioning adolescents living with HIV (ALHIV) from pediatric to adult care (Intervention Group; IG) versus the usual abrupt transfer to adult care (Control group; CG) on rates of retention in care and viral suppression, and differences in perceived psychosocial wellbeing. Twelve health facilities, two in each of the six geopolitical zones of Nigeria will be pair-matched and randomly assigned to either IG (N=6 health facilities) or CG (N=6 health facilities). A total of 216 ALHIV will be enrolled in the study over a 36-month period. The primary outcome will be the difference in the rate of retention between the groups. Secondary outcomes will be difference in the rate of viral suppression and the difference in perceived psychosocial wellbeing. Additionally, the investigators will conduct mediation/moderation analysis to examine the role of intermediate variables such as transition readiness, perceived mental health, social support, health locus of control, self-esteem and sexual risk behavior self-efficacy on the primary outcomes. Implementation factors will be assessed using the hybrid 2 model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV infection
- •Aware of HIV diagnosis
- •Currently on ART
排除标准
- •Medically unstable
研究组 & 干预措施
Control
The control arm does not receive the ACT intervention.
ACT Intervention
Intervention activities include the three components of the ACT intervention: (1) alternating pediatric and adult clinic visits in the 12 month pre-transfer period (2) peer facilitated organized support group during the 24-month graduated transition period and (3) patient advocate and case management team to coordinate transfer process.
干预措施: ACT (Other)
结局指标
主要结局
Retention in care in care 6 months post-transfer
时间窗: 6 months
Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer
Retention in care 12 months post-transfer
时间窗: 12 months
Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within the 1 year period post-transfer
Retention in care 24 months post-transfer
时间窗: 24 months
Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within a 1 year period during the second year post-transfer
次要结局
- Viral Suppression(Enrollment, baseline (12 months), 24 and 36 months)
- Mental Health and Wellbeing(Enrollment, baseline (12 months), 24 and 36 months)
- Health Locus of Control(Enrollment, baseline (12 months), 24 and 36 months)
- Social Support(Enrollment, baseline (12 months), 24 and 36 months)
- Sexual Risk Behavior(Enrollment, baseline (12 months), 24 and 36 months)
- Transition Readiness(Enrollment, baseline (12 months), 24 and 36 months)
研究者
Echezona Ezeanolue
Professor of Public Health and Pediatrics
University of Nevada, Las Vegas