STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility/acceptability will be assessed using the CAB Community Needs Assessment
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. Phase 1 the R61 portion of the project will be a Pilot Study, and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot (NCT07223398).
The focus of this registration is the pilot study. In Year 1 (R61; Aim 1) the intervention of the patient choice menu of options of PrEP/ART and SUD treatment services for justice involved people who use drugs (PWUD) to supplement established peer navigation (PN +PC) will be developed and pilot tested in Western Connecticut only (Fairfield, Litchfield, Southern New Haven Counties).
Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community, as well as gaps in services and ideas of how services can be improved. These needs assessment surveys and focus groups will occur 3 times throughout 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 6 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 and have a viral load >200 copies/mL in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 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 within 12 months prior to being in a controlled setting and/or in the last 6 months within the community
- •Implementation portion/CAB members:
- •able to provide written informed consent in English or Spanish;
- •working with persons with a history of justice involvement and substance use in the areas targeted for this project
- •PN Participants:
- •able to provide written informed consent in English or Spanish;
- •be employed at a project research site as a Patient Navigator
排除标准
- •severe medical or psychiatric disability making participation unsafe;
- •unable to provide consent.
- •persons self-reporting pregnancy
- •Implementation portion/CAB members:
- •persons self-reporting pregnancy
研究组 & 干预措施
PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB.
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 the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB.
干预措施: Patient Choice (Behavioral)
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 appointment scheduling to brick and mortar services only, and not to MHU or telehealth services.
干预措施: Standard PN (Behavioral)
结局指标
主要结局
Feasibility/acceptability will be assessed using the CAB Community Needs Assessment
时间窗: 3 months
Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation.
Feasibility/acceptability will be assessed using the Organizational Readiness for Implementing Change (ORIC) from the JCOIN Common Measure survey
时间窗: 3 months
Organizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach.
Participant attitudes toward the interventions will be assessed using the Scales for Participant Alliance with Recovery Coach (SPARC)
时间窗: 3 months
Participant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50.
Percentage of participants with receipt of treatment
时间窗: 3 months
Defined as participants that have received a prescription for PrEP/ART
Percentage of participants with access to PrEP/ART services
时间窗: 3 months
Utilization of Services and PN Engagement data will be used to assess the percentage of participants with access to PrEP/ART services.
Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment
时间窗: 3 months
Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation. Total score range is 5-20 for each category. Higher scores indicate increased acceptability, appropriateness, and feasibility. Assessed only in CAB members.
Feasibility/Acceptability Will be Assessed Using the Organizational Readiness for Implementing Change (ORIC) From the JCOIN Common Measure Survey
时间窗: 3 months
Organizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach. Total scores range from 12 to 60, with higher scores indicating greater readiness. This survey was administered to CAB members only.
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
时间窗: 3 months
Participant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50.
Number of Participants That Utilized Access of PrEP/ART Services
时间窗: 3 months
Utilization of Services and PN Engagement data will be used to assess the number of participants that utilized access of PrEP/ART services.
Number of Participants With Receipt of Treatment
时间窗: 3 months
Defined as participants that have received a prescription for PrEP/ART
次要结局
- Substance use treatment(3 months)
- Substance Use Treatment(3 months)