TechMPower: Advancing HIV/SUD Care and Service Delivery for People Involved in the Criminal Legal System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Number of people incarcerated who have received an HIV test
研究概览
简要总结
The goal of this clinical study in one NY county is to pilot and refine implementation strategies aimed at improving delivery and uptake of evidence-based practices (EBPs) for HIV prevention/treatment and substance use disorder (SUD) care among incarcerated individuals approaching release with or at risk for HIV and SUD.
The main questions it aims to answer are:
- How feasible and acceptable are the TechMPower implementation strategies (community coalition workgroups, multidisciplinary implementation team with champion, and tech-mediated training/service delivery with peer navigation) in real-world carceral and reentry settings?
- To what extent do these strategies improve delivery and uptake of HIV testing with self-testing (HST), pre-exposure prophylaxis (PrEP)/antiretroviral treatment (ART), medications for opioids use disorder (MOUD), and overdose education and naloxone distribution (OEND)?
- What are the preliminary cost estimates for the implementation strategies and EBPs to inform the larger trial to follow in NY and NJ?
- What are the preliminary impacts on individual-level outcomes such as HIV testing, linkage to care, and SUD treatment initiation?
Our specific aims for the Phase I protocol presented here is conducted in one county (Ulster County) with a sample (n=50) of detained (prisoners) in their county jail are presented here:
- R61 | Aim 1: Evaluate \ preliminary effectiveness of TechMPower, using mixed methods and a pre-/post-evaluation design, on increasing reach of the EBPs resulting in the following outcomes: (1) SUD and HIV screenings (pre-/post-release); and (2) linkage to SUD prevention/care (MOUD, OEND); and (3) linkage to HIV prevention/care (applying a status-neutral approach) with community service providers post-release. (Effectiveness).
- R61 | Aim 2: Identify how adoption/feasibility, implementation/fidelity and sustainability/maintenance of TechMPower may impact effectiveness of TechMPower outcomes as described in Aim 1 in one (Ulster County) jail using surveys of Implementation Team, jail staff and other key stakeholders. (Implementation)
- R61 | Aim 3: Use implementation mapping to adapt implementation strategies for R33 phase. (Implementation)
详细描述
HIV prevalence in correctional facilities in the US is about five times greater than in the general population and about 14% of people living with HIV (PLWH) experience incarceration/release every year and 15% of those incarcerated do not know their HIV status. Over 50,000 people are incarcerated in New York state and 1-2% are estimated to be PLWH. Similarly, substance use disorder (SUD) is highly prevalent among criminal-legal system (CLS)-involved people, with an estimated 70-80% of US jail detainees having a SUD are at high risk of relapse, overdose-related mortality and HIV infection post-release. Intervening during incarceration provides an opportunity to address HIV care in hard-to-reach individuals, though more robust interventions and staff training is needed to improve care continuity. Increasing point-of-care rapid testing would maximize HIV detection and results receipt among people in jails, and prepare them with needed knowledge and skills post-release.
To fill this gap, the investigators propose a Regional Research Hub (RRH) and 2-phase, Hybrid Type II effectiveness/implementation study to evaluate the effectiveness of TechMPower, an intervention that bundles implementation strategies to increase delivery of evidence-based intervention (EBPs) to prevent adverse HIV-related (new infection, untreated HIV) and SUD-related outcomes (fatal and non-fatal overdose) among a sample of individuals (n=1200) in 6 New York and New Jersey State County jails. In the first phase submitted in this IRB protocol, the researchers will pilot TechMPower to prepare for the phase two full R33 trial, informed by PRISM/RE-AIM and the health equity framework, by recruiting in one NYS county jail (n=50) and an existing HEALing Communities Study coalition workgroup to evaluate the training on and implementation of the selected EBPs required as standard of care in jails. This record contains the R61 pilot portion.
Researchers will compare outcomes before and after implementation of the strategy bundle to see if TechMPower improves reach, adoption, implementation fidelity, and sustainability of integrated HIV/SUD services.
Participants incarcerated (N=50) will:
- Complete baseline and 3-month follow-up surveys on HIV/SUD behaviors and care engagement
- Participate in up to 60-minute qualitative interviews (subset N=8)
- Receive potential HIV/STI testing, referrals to prevention/treatment, and linkage services including peer navigation enhanced case management (NCM)
- Receive HIV self-test kit and Naloxone upon release
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •≥18 years old
- •speaks and understands English
- •report using any illicit drug, in the six months prior to incarceration
- •report having had condomless receptive and/or insertive vaginal and/or anal sex without either condom use, AND/OR report another HIV risk in the six months prior to incarceration (i.e. shared syringes, STI+)D
- •likely to be released in the next 1-3 months
排除标准
- •evidence of significant psychiatric or cognitive impairment that would limit effective participation as confirmed during informed consent assessed during informed consent or confirmed by the MacArthur Competence Assessment Tool
- •not fluent in English
研究组 & 干预措施
TechMPower Implementation Strategies
TechMPower applies evidence-based Implementation Strategies, including:
A) data-driven, Community Coalitions and criminal legal system (CLS) focused workgroup informed by the HEALing Communities Study (HCS) Communities That HEAL(CTH intervention); B) Implementation Team led by champions; C) training on optimal person-centered service delivery for service providers/organizations; and D) tech-mediated service delivery, technical assistance, and training to increase: 1) HIV screening/testing via self-testing; 2) SUD screening, brief interview and referral to treatment (SBIRT); and 3) access to and uptake of biomedical HIV and SUD prevention and treatment (PrEP/PEP/ART); overdose education/naloxone distribution [OEND], opioid use disorder medication [MOUD]) delivered through 4) hybrid linkage (telehealth, face-to-face) to services via Navigation Enhanced Case Management (NCM).
干预措施: Tech-mediated Training and Service Delivery (Behavioral)
TechMPower Implementation Strategies
TechMPower applies evidence-based Implementation Strategies, including:
A) data-driven, Community Coalitions and criminal legal system (CLS) focused workgroup informed by the HEALing Communities Study (HCS) Communities That HEAL(CTH intervention); B) Implementation Team led by champions; C) training on optimal person-centered service delivery for service providers/organizations; and D) tech-mediated service delivery, technical assistance, and training to increase: 1) HIV screening/testing via self-testing; 2) SUD screening, brief interview and referral to treatment (SBIRT); and 3) access to and uptake of biomedical HIV and SUD prevention and treatment (PrEP/PEP/ART); overdose education/naloxone distribution [OEND], opioid use disorder medication [MOUD]) delivered through 4) hybrid linkage (telehealth, face-to-face) to services via Navigation Enhanced Case Management (NCM).
干预措施: Community Coalition CLS Workgroup/Network of Providers (Behavioral)
TechMPower Implementation Strategies
TechMPower applies evidence-based Implementation Strategies, including:
A) data-driven, Community Coalitions and criminal legal system (CLS) focused workgroup informed by the HEALing Communities Study (HCS) Communities That HEAL(CTH intervention); B) Implementation Team led by champions; C) training on optimal person-centered service delivery for service providers/organizations; and D) tech-mediated service delivery, technical assistance, and training to increase: 1) HIV screening/testing via self-testing; 2) SUD screening, brief interview and referral to treatment (SBIRT); and 3) access to and uptake of biomedical HIV and SUD prevention and treatment (PrEP/PEP/ART); overdose education/naloxone distribution [OEND], opioid use disorder medication [MOUD]) delivered through 4) hybrid linkage (telehealth, face-to-face) to services via Navigation Enhanced Case Management (NCM).
干预措施: Multidisciplinary Implementation Team with Champion (Behavioral)
TechMPower Implementation Strategies
TechMPower applies evidence-based Implementation Strategies, including:
A) data-driven, Community Coalitions and criminal legal system (CLS) focused workgroup informed by the HEALing Communities Study (HCS) Communities That HEAL(CTH intervention); B) Implementation Team led by champions; C) training on optimal person-centered service delivery for service providers/organizations; and D) tech-mediated service delivery, technical assistance, and training to increase: 1) HIV screening/testing via self-testing; 2) SUD screening, brief interview and referral to treatment (SBIRT); and 3) access to and uptake of biomedical HIV and SUD prevention and treatment (PrEP/PEP/ART); overdose education/naloxone distribution [OEND], opioid use disorder medication [MOUD]) delivered through 4) hybrid linkage (telehealth, face-to-face) to services via Navigation Enhanced Case Management (NCM).
干预措施: Tech-mediated Peer Navigation Enhanced Case management (NCM) (Behavioral)
结局指标
主要结局
Number of people incarcerated who have received an HIV test
时间窗: Baseline and 3 months follow-up
This is to measure HIV testing (including self-testing) at jail. The number of participants that report in survey at least 1 testing will be tallied. Aggregate reporting on testing from facility will be captured for triangulation.
Number of people detained screened for SBIRT
时间窗: Baseline and 3 months follow-up
This is to measure the feasibility, efficacy of Screening, Brief Intervention and Referral to treatment (SBIRT) for SUD at jail. The number of participants that report in survey receiving SBIRT will be tallied. Aggregate reporting on SBIRT from facility will be captured for triangulation.
HIV care access & utilization/ART Use/adherence/viral load/CD4 count
时间窗: 3-month following pos test result, pre- post release
Service Use Measure: at least one visit to HIV-focused medical at clinic post release. The number of participants that report in surveys receiving HIV treatment will be tallied. Aggregate reporting on HIV treatment from facility referrals will be captured for triangulation.
Average PrEP oral daily/injectable/episodic PrEP captured in records/chart review; ACASI self-report
时间窗: Baseline and 3 months follow-up
This is to measure PrEP use, adherence \& discontinuation
PEP uptake rate
时间窗: Baseline and 3 months follow-up
This is to measure PEP use by seeing the uptake: starter pack \& full treatment provision/fulfillment and adherence, PEP to PrEP transition
次要结局
- Number of clients referred and assessed for NCM(Baseline and 6 months)
- Number of people incarcerated receiving OEND(Baseline and 3 months follow-up)
- Number of staff receiving training on TechMPower integrated SUD/HIV service delivery(Baseline and 6 months follow up)
研究者
Timothy Hunt
Associate Research Scientist in the Faculty of Social Work
Columbia University