City-Wide Implementation and Evaluation of the B-OK Bottles for HIV Treatment Adherence Support in the Philadelphia Ryan White Medical Case Management Network
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 390
- 主要终点
- HIV viral suppression
研究概览
简要总结
We will conduct a hybrid implementation-effectiveness study of a city-wide B-OK rollout led by PDPH with research and evaluation support from the University of Pennsylvania. The rollout uses a randomized stepped-wedge design across the 21 MCM sites that have not previously received B-OK. The four pilot sites that received bottles without structured training in late 2023 will now also receive the full package and be trained but be analyzed as a separate stratum given prior exposure. The evaluation is organized under RE-AIM, with implementation outcomes defined using Proctor's taxonomy and contextual determinants assessed using CFIR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical Case Managers (MCM) from the 25 agencies that received Ryan White funding for HIV medical case management in Philadelphia in 2025
- •Clients living with HIV that receive case management from one of the 25 agencies that received Ryan White funding for HIV medical case management in Philadelphia in 2025
排除标准
- •Unwilling or unable to provide consent for study participation
研究组 & 干预措施
Clients living with HIV
Client are individuals who are living with HIV who receive care at one of Philadelphia's Ryan White-funded network
干预措施: B-OK Bead Bottles (Behavioral)
Medical Case Managers
Medical case managers (MCMs) in Philadelphia's Ryan White-funded network
干预措施: B-OK Bead Bottles (Behavioral)
结局指标
主要结局
HIV viral suppression
时间窗: Every 6 months
Binary, assigned to each client active at a participating site as of the end of each two-month (bimonthly) observation period. A client is classified as virally suppressed for a period if they had at least one viral load measured during the 6 months ending at the close of that period and the most recent such viral load was \<200 copies/mL; clients with no viral load measured during that 6-month window are classified as not suppressed. This is consistent with the PDPH surveillance definition of viral suppression and allows every active client to be classified in every period (baseline city average 74.4%).
次要结局
- Engagement in care(Every 6 months)