共同决策治疗或预防（STOP）司法人群中的艾滋病（R33）
STOP（共同决策治疗或预防）司法人群中的HIV
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Alysse Schultheis, MA
- 电话号码：203-231-2454
- 邮箱：alysse.schultheis@yale.edu
研究联系人备份
- 姓名：Sandra Springer, MD
- 电话号码：203-231-2454
- 邮箱：Sandra.springer@yale.edu
学习地点
-
-
Connecticut
-
New Haven、Connecticut、美国、06510
- 招聘中
- Yale School of Medicine
-
首席研究员：
- Sandy Springer, MD
-
-
Kentucky
-
Lexington、Kentucky、美国、40506
- 招聘中
- College of Medicine at the University of Kentucky
-
首席研究员：
- Michele Staton, PhD, MSW
-
-
Texas
-
Dallas、Texas、美国、75390
- 招聘中
- University of Texas Southwestern Medical Center (UTSW)
-
首席研究员：
- Ank Nijhawan, MD, MPH
-
Fort Worth、Texas、美国、76109
- 招聘中
- Texas Christian University's (TCU) School of Medicine
-
首席研究员：
- Kevin Knight,, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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. |
Standard of care |
|
实验性的：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. |
Standard of care Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of participants who initiate or re-initiate PrEP
大体时间：6 months
|
Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report |
6 months
|
|
Percentage of participants who initiate or re-initiate ART
大体时间：6 months
|
Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of participants that adhere to PrEP
大体时间：6 and 12 months
|
Percentage of participants that adhere to PrEP |
6 and 12 months
|
|
Percentage of participants retaining on PrEP
大体时间：6 and 12 months
|
Percentage of participants retaining on PrEP |
6 and 12 months
|
|
HIV incidence
大体时间：6 and 12 months
|
HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time |
6 and 12 months
|
|
Percentage of participants that adhere to ART
大体时间：6 and 12 months
|
Percentage of participants that adhere to ART |
6 and 12 months
|
|
ART retention
大体时间：6 and 12 months
|
For persons living with HIV (PLH), ART retention [binary] |
6 and 12 months
|
|
Substance use treatment
大体时间：6 and 12 months
|
Percentage of participants engaged in substance use disorder (SUD) treatment |
6 and 12 months
|
|
HIV viral suppression
大体时间：6 months
|
For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months |
6 months
|
|
Retention in HIV PrEP/ART
大体时间：6 months
|
Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months |
6 months
|
|
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior
大体时间：6 and 12 months
|
Number of Participants Who Had Any Needle Sharing Activity |
6 and 12 months
|
|
Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior
大体时间：6 and 12 months
|
Number of Participants Who Had Vaginal or Anal Sex Without a Condom |
6 and 12 months
|
|
Days of using opioids
大体时间：6 and 12 months
|
Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use |
6 and 12 months
|
|
Number of participants with with overdose events
大体时间：6 and 12 months
|
Number of participants with non-fatal and fatal overdose events |
6 and 12 months
|
|
Percentage of participants with retention in SUD treatment
大体时间：6 and 12 months
|
Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD) |
6 and 12 months
|
|
Quality of Life assessed using PROMIS-PROPr
大体时间：6 and 12 months
|
PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health. |
6 and 12 months
|
|
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
大体时间：6 and 12 months
|
Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. |
6 and 12 months
|
|
Recidivism: Reasons
大体时间：6 and 12 months
|
Number of participants per reason for arrest/ incarceration/return-to-custody |
6 and 12 months
|
|
Recidivism: Mean days in custody/incarcerated
大体时间：6 and 12 months
|
Mean days in custody/incarcerated |
6 and 12 months
|
|
Recidivism: Mean days to return
大体时间：6 and 12 months
|
Mean days to return to custody/incarcerated |
6 and 12 months
|
|
HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)
大体时间：6 and 12 months
|
Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma |
6 and 12 months
|
|
Percentage of participants diagnosed with SUD
大体时间：Baseline and 12 months
|
Percentage of participants diagnosed with SUD using DSM-5 |
Baseline and 12 months
|
合作者和调查者
调查人员
- 首席研究员：Sandra Springer, MD、Yale University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.