Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Number of participants who initiate PrEP
研究概览
简要总结
The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ).
This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.
详细描述
Problem: There is urgent need to reach women involved in criminal justice (WICJ) for lifesaving, evidence-based PrEP and medications for OUD (MOUD), using innovative healthcare delivery models that surmount existing social and structural barriers to engagement.
Purpose: This study uses a newly validated decision aid and eHealth to remotely deliver integrated PrEP and MOUD to community-based WICJ with OUD in New Haven, Connecticut (CT) and Birmingham, Alabama (AL).
Methods: 250 PrEP-eligible WICJ with OUD will undergo randomization to: a) the "Athena" strategy, which includes the decision aid + eHealth for remote integrated PrEP/MOUD with a provider using outputs from the decision aid; or b) decision aid-only with referral to community-based PrEP/MOUD. Randomization will be stratified by site; past 6-month use of any stimulants; and baseline receipt of MOUD. Follow-up study assessments occur at months 1, 3, and 6. To understand implementation, the investigators will conduct population modeling and engage with relevant stakeholders through focus groups using nominal group technique and in-depth individual interviews.
Aims: The Aims of the project are: 1) To compare the Athena strategy to decision aid-only in terms of patient-level engagement in the PrEP and OUD care continua, considering key site differences; and 2) To assess scale-up potential of the Athena strategy in terms of modelled long-term outcomes and how stakeholders interact with eHealth for integrated PrEP/MOUD in WICJ in two diverse epidemiological and implementation contexts (CT and AL), using standardized definitions of implementation outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •have access to a working mobile or landline phone
- •Lifetime CJ-involvement (probation, parole, intensive pretrial or community supervision, or release from prison/jail)
- •are confirmed HIV-negative by point-of-care 3rd generation HIV antibody test
- •meet clinical criteria for PrEP
- •have opioid use disorder (regardless of baseline treatment status)
排除标准
- •unable or unwilling to provide informed consent
- •pregnant or breast-feeding
- •currently taking PrEP at the time of study enrollment
- •not comfortable conversing in English or Spanish.
研究组 & 干预措施
Athena Strategy
Virtual care model that includes direct synchronous videoconferencing with a provider, telephone/ texting communication, electronic health records, e-prescribing for the purposes of delivering PrEP and medications for opioid use disorder. This is combined with a decision aid for PrEP
干预措施: Athena strategy (Combination Product)
Decision Aid
Decision aid for PrEP tailored for justice-involved women with opioid use disorder
干预措施: Decision Aid (Behavioral)
结局指标
主要结局
Number of participants who initiate PrEP
时间窗: up to 6 months
PrEP in initiation will be determined using dates of prescription and pharmacy fill and medication type (brand/generic)
次要结局
- Number of participants who are adherent to PrEP(up to 6 months)
- Number of participants who engage in opioid use disorder treatment(up to 6 months)