Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,920
- 试验地点
- 25
- 主要终点
- Effectiveness: Retention
研究概览
简要总结
Ending the HIV epidemic for youth living with HIV will require implementation and optimization of evidence-based interventions that address barriers to treatment. The proposed implementation study will test a youth-led data-driven implementation strategy to scale-up an evidence-based Adolescent Transition Package (ATP) aimed at improving transition processes and post-transition clinical outcomes for youth living with HIV in Kenya. Clinics will be randomized to receive standard of care implementation through trainer of trainers or the youth-led data-driven implementation strategy alongside trainer of trainers. We will study whether the enhanced implementation strategy improves the number of youth who receive the ATP, the number of providers that initially chose to use the ATP, and the consistency with which the ATP is used over time. We will also evaluate the cost of the ATP and whether the ATP improves health outcomes among youth living with HIV, including viral suppression and retention in care. Healthcare workers at study sites will complete surveys, focus group discussions, interviews, and participate in continuous quality improvement processes. Youth will participate in surveys and focus groups, and have their routine medical records abstracted.
详细描述
The proposed project extends the team's previously conducted cluster randomized controlled trial, the Adolescent Transition to Adult Care (ATTACH) study (NIH R01HD089850-01; PI John-Stewart). This new R01 tests an implementation strategy to improve scale up of an Adolescent Transition Package (ATP), developed during the previous clinical trial, within health facilities in Kenya and evaluate the cost-effectiveness and budget impact of the implementation strategy. Primary outcomes include measuring intervention uptake and delivery outcomes using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, factors influencing implementation, clinical outcomes, and cost.
The ATP is a healthcare worker (HCW) delivered toolkit that supports the transition from pediatric to independent care for youth living with HIV (YLH). The ATP was developed by the ATTACH study, working in partnership with the Kenya Ministry of Health and other key collaborators leading treatment and care provision in Kenya. The ATP is designed to support transition to adult care for YLH and provide YLH with the knowledge and skills needed to independently manage HIV. The ATP combined two evidence-based interventions from other contexts (Namibia and the United States) and adapted them to better meet Kenyan patient, provider and health system needs. The ATP was tested in a randomized controlled trial of 20 clinics in 4 counties in Kenya (ATTACH study), and shown to significantly improve readiness to transition among YLH in intervention sites compared to those in the control. HCWs and YLH appreciated the content and design of the ATP as they found it feasible and acceptable for routine clinic use.
During this scale up focused R01, the ATP will be administered at the clinic level by existing HCWs during routine YLH clinic visits, as in the original trial. In all participating clinics, all eligible adolescents aged 10-24 years will have medical record data abstracted, and older YLH (ages 15-24) will be offered the opportunity to participate in surveys and qualitative data collection. HCWs from participating clinics will provide feedback on implementation throughout the study and work to optimize delivery of the ATP within their clinic settings.
The ATTACH-Scale study includes implementation of the ATP in 32 clinics. The 32 study sites for this R01 will be selected from a large list of eligible facilities, and specific clinics will be selected by prioritizing high HIV volume clinics (>50 YLH per clinic), existing collaborations (ex: ATTACH study sites), and MoH priorities. Selection of intervention and control sites will be done using stratified randomization, balancing for county and model of HIV care in the clinic, by a biostatistician based at the University of Washington. The units of analysis vary by study aim, and are either at the level of the HCW, YLH, or clinic, depending on the specific aim and outcome being assessed.
Specific details for each study aim are described below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare providers
- •≥18 years of age
- •Employed at one of the 32 facilities in the RCT
- •Provides HIV services to adolescents affiliated within their clinic Adolescents and youth living with HIV
- •Between 15-24 years of age (focus group discussions, surveys) or between 10-24 years of age (offered the intervention)
- •Receives HIV clinical care at one of the clinics included in the study
- •Attended clinic ≥1 time following intervention implementation
排除标准
- •Any individual who meets the following criteria will be excluded from participation in this study:
- •- Conditions that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
研究组 & 干预措施
Training of trainers
Sites assigned to the standard of care (SoC) control arm will receive cascading training of trainers (ToTs) and cascade training to sites for supporting scale-up of the ATP
Youth Enhanced Implementation Strategy (ATP-YES)
Sites assigned to the intervention arm will receive the ATP-YES implementation strategy, a multi-component youth led implementation strategy that incorporates data audits and feedback, cyclical small tests of change and learning collaboratives, to support scale-up of the ATP
干预措施: ATP-Youth Enhanced Strategy (ATP-YES) (Other)
结局指标
主要结局
Effectiveness: Retention
时间窗: From enrollment through 6 months post study end (42 months)
Number of scheduled clinic visits youth living with HIV attend in the year after transition to adult care
Adoption
时间窗: From enrollment through 6 months post study end (42 months)
Proportion of health providers in youth HIV clinics who deliver the ATP
Reach
时间窗: From enrollment through 6 months post study end (42 months)
Proportion of youth living with HIV ages 15-24 years exposed to the ATP intervention
Effectiveness: Successful Transfer
时间窗: From enrollment through 6 months post study end (42 months)
Proportion of youth living with HIV who attend first adult clinic visit
次要结局
- Effectiveness: Transition Readiness(From enrollment through 6 months post study end (42 months))
- Effectiveness: Viral Suppression(From enrollment through 6 months post study end (42 months))
- Implementation: Fidelity to ATP(From enrollment through 6 months post study end (42 months))
- Implementation: Fidelity to ATP-YES(From enrollment through 6 months post study end (42 months))
- Maintenance(From study end (36 months) through 6 months post study end (42 months))
研究者
Kristin Beima-Sofie
Senior Research Scientist
University of Washington