Clinical Trials Directory

Trials / Completed

CompletedNCT07088770

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

TechMPower: Advancing HIV/SUD Care and Service Delivery for People Involved in the Criminal Legal System

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
65 (actual)
Sponsor
Columbia University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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)

Detailed 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

Conditions

Interventions

TypeNameDescription
BEHAVIORALCommunity Coalition CLS Workgroup/Network of ProvidersCommunity Coalition/Network of Providers TechMPower forms the foundation of community engagement in this approach, with membership including PLWH and SUD, sheriffs, within-jail staff, community service providers or other partners who are able to advance the adoption of EBPs within jail and service settings. All coalitions are trained and prepared to drive a planning process at the local level for efficient identification and allocation of resources needed to link people from CLS to a network of community providers for HIV and SUD care and retention. Community coalitions integrate evidence-based (ERIC) strategies: Build coalition; Promote network weaving; Identify/train champions; Conduct consensus discussions that support needed services.
BEHAVIORALTech-mediated Training and Service DeliveryResearchers will train all staff, healthcare providers and peer navigators to recognize and reduce stigma in CLS and healthcare settings using a training program informed by MPI Frye and colleagues in the CHHANGE (MH102182-01) intervention, which developed an anti-intersectional stigma training program for CBOs and offers comprehensive training to healthcare and social service organizations. Additionally, researchers will train staff and support protocol enhancements as needed to utilize tech mediated service delivery for NCM in-reach and services coordination in the community. These integrate 5 evidence-based (ERIC) implementation strategies: promote consultation; provide clinical/technical supervision; centralize technical assistance; change physical structure and equipment.
BEHAVIORALMultidisciplinary Implementation Team with ChampionThe multidisciplinary Implementation Team will be comprised of a correctional health nurse, social worker and discharge planner or counselor and corrections officer from the jail. A representative from the community coalition and peer and case manager from NCM will join the team using a tech-mediated platform for conducting the training and for on-going weekly case conferencing addressing system and client level barriers and service planning. The role of the champion from the correctional setting will be to convene meetings focused on fidelity to the intervention components, engagement in shared problem-solving and mediation of administrative issues that may inhibit effective implementation of TechMPower. The champion and implementation team may request technical assistance (TA) or implementation facilitation at any point during implementation. This TA may be provided by the investigative team or outside providers from federal programs.
BEHAVIORALTech-mediated Peer Navigation Enhanced Case management (NCM)Navigation-Enhanced Case Management (NCM) uses Project START, a CDC best evidence intervention as its HIV risk reduction framework. Prior to release, a case manager and peer navigator via telehealth and in-person provide discharge planning and patient education and serves as a liaison to the courts. After release, patient navigators facilitate reentry into community care and provide referrals to HIV medical and SUD care as appropriate (e.g., ART, PrEP, MOUD) and assistance with food, housing, transportation, employment, substance dependence, mental health treatment, and legal issues. TechMPower planned to enhance tracking of linkage during NCM services by integrating reporting along with a web-based platform that tracks assignment of providers and peers and follows for 6 months to capture PRISM linkage and retention in MOUD, HIV and ancillary care.

Timeline

Start date
2024-11-22
Primary completion
2025-09-30
Completion
2025-09-30
First posted
2025-07-28
Last updated
2026-02-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07088770. Inclusion in this directory is not an endorsement.