TechMPower: Advancing HIV/SUD Care and Service Delivery for People in Re-entry
- Conditions
- HIV (Human Immunodeficiency Virus)Substance Abuse Disorder
- Registration Number
- NCT07088770
- Lead Sponsor
- Columbia University
- Brief 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 65
Participants incarcerated are eligible if:
- they are ≥18 years old; AND
- speaks and understands English (for the pilot study); AND
- report using any illicit drug, in the six months prior to incarceration; AND
- 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+) AND
- are likely to be released in the next 1-3 months.
Participants will be excluded if:
- 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; or
- are not fluent in English as determined during informed consent for this pilot study, R61.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of people incarcerated who have received an HIV test 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 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 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 Baseline and 3 months follow-up This is to measure PrEP use, adherence \& discontinuation
PEP uptake rate 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
- Secondary Outcome Measures
Name Time Method Number of clients referred and assessed for NCM Baseline and 6 months This is to measure the feasibility of Navigation Enhanced Case Management (NCM). The number of participants that report in survey receiving NCM will be tallied. Aggregate reporting on NCM service delivery will be captured for triangulation.
Number of people incarcerated receiving OEND Baseline and 3 months follow-up This is to measure the Overdose education and Naloxone Distribution (OEND) feasibility at jail. The number of participants that report in survey receiving OEND will be tallied. Aggregate reporting on OEND service delivery from facility will be captured for triangulation.
Number of staff receiving training on TechMPower integrated SUD/HIV service delivery Baseline and 6 months follow up This is to measure the feasibility of TechMPower techmediated training and HIV/SUD integrated service delivery. This is reported on surveys and aggregate reporting on techmediated training attendance logs for triangulation.
Trial Locations
- Locations (1)
Ulster County Jail
🇺🇸Kingston, New York, United States
Ulster County Jail🇺🇸Kingston, New York, United States