STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Percentage of participants who initiate or re-initiate PrEP
研究概览
简要总结
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
详细描述
This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.
The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •able to provide written informed consent in English or Spanish;
- •living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
- •Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);
- •willing to have HIV testing to determine negative or positive status;
- •persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
- •Having a history of opioid and/or stimulant use in the last 12 months within the community.
排除标准
- •severe medical or psychiatric disability making participation unsafe;
- •unable to provide consent.
- •persons self-reporting pregnancy
研究组 & 干预措施
Standard Patient Navigation (PN)
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling.
干预措施: Standard PN (Behavioral)
PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment.
干预措施: Standard PN (Behavioral)
PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment.
干预措施: Patient Choice (Behavioral)
结局指标
主要结局
Percentage of participants who initiate or re-initiate PrEP
时间窗: 6 months
Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report
Percentage of participants who initiate or re-initiate ART
时间窗: 6 months
Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report
次要结局
- Percentage of participants that adhere to PrEP(6 and 12 months)
- Percentage of participants retaining on PrEP(6 and 12 months)
- HIV incidence(6 and 12 months)
- Percentage of participants that adhere to ART(6 and 12 months)
- ART retention(6 and 12 months)
- Substance use treatment(6 and 12 months)
- HIV viral suppression(6 months)
- Retention in HIV PrEP/ART(6 months)
- Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior(6 and 12 months)
- Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior(6 and 12 months)
- Days of using opioids(6 and 12 months)
- Number of participants with with overdose events(6 and 12 months)
- Percentage of participants with retention in SUD treatment(6 and 12 months)
- Quality of Life assessed using PROMIS-PROPr(6 and 12 months)
- Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)(6 and 12 months)
- Recidivism: Reasons(6 and 12 months)
- Recidivism: Mean days in custody/incarcerated(6 and 12 months)
- Recidivism: Mean days to return(6 and 12 months)
- HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)(6 and 12 months)
- Percentage of participants diagnosed with SUD(Baseline and 12 months)