Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers: A Stepped Wedge Hybrid Type II Effectiveness Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- Undetectable HIV viral load (<20 copies/ml)
研究概览
简要总结
The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, the investigators will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. The set of implementation strategies include task-shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. The investigators will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that will best support implementation. Each clinic will be randomized to one of three implementation start times. Baseline (usual care) data will be collected from each clinic for 6 months, followed by MAPS+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategies on reach. Implementation cost will also be measured. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. The results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the "treat" pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •a man or woman living with HIV
- •not retained in care and/or virally suppressed in year prior to trial initiation
排除标准
- •- incarcerated during the duration of the trial
研究组 & 干预措施
MAPS+
干预措施: Managed Problem Solving (MAPS) (Behavioral)
Standard of Care
结局指标
主要结局
Undetectable HIV viral load (<20 copies/ml)
时间窗: One year
It is defined as having a viral load \<20 copies/mL using the last available viral load at the end of one year (+/-60 days ) since trial initiation. VLs will be abstracted from the electronic medical record along with the date of lab collection.
次要结局
- Retention in care(One year)
- Adherence to HIV therapy(One year)
- CD4 Count(One year)
研究者
Florence Momplaisir, MD
Assistant Professor
University of Pennsylvania
