TechMPower: Advancing HIV/SUD Care and Service Delivery for People in Re-entry (TMP Project)

Columbia University

Status: Active, not recruiting

Conditions: HIV (Human Immunodeficiency Virus); Substance Abuse Disorder

Treatments: Behavioral: Community Coalition CLS Workgroup/Network of Providers; Behavioral: Tech-mediated Peer Navigation Enhanced Case management (NCM); Behavioral: Multidisciplinary Implementation Team with Champion; Behavioral: Tech-mediated Training and Service Delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07088770

AAAV1468

1R61DA060620-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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:

1. 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?
2. 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)?
3. What are the preliminary cost estimates for the implementation strategies and EBPs to inform the larger trial to follow in NY and NJ?
4. 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)

Full description

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:

1. Complete baseline and 3-month follow-up surveys on HIV/SUD behaviors and care engagement
2. Participate in up to 60-minute qualitative interviews (subset N=8)
3. Receive potential HIV/STI testing, referrals to prevention/treatment, and linkage services including peer navigation enhanced case management (NCM)
4. Receive HIV self-test kit and Naloxone upon release

Stakeholder participants (N=20) will:

1. Complete baseline and 3-month follow-up surveys on HIV/SUD behaviors and care engagement
2. Participate in up to 60-minute qualitative interviews (subset N=8)
3. Receive training in HIV and SUD screening and treatment referral (SBIRT), HST and OEND, person-centered approach to care linkage; tech-mediated training and service delivery; and in NCM
4. Participate in coalition workgroup, implementation team and implementation of NCM

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

TechMPower Implementation Strategies

Experimental group

Description:

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).

Treatment:

Behavioral: Tech-mediated Training and Service Delivery

Behavioral: Multidisciplinary Implementation Team with Champion

Behavioral: Tech-mediated Peer Navigation Enhanced Case management (NCM)

Behavioral: Community Coalition CLS Workgroup/Network of Providers