Clinical trial NCT06679751: Infectious Disease (ID) Testing OUtreach in Carceral Hubs
Official title: Massachusetts HIV and Justice Involved Populations Research Network
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
Opioid Use Disorder
Keywords: Carceral system
HIV testing
Pre-exposure prophylaxis (PrEP)
Justice Community Opioid Innovation Network (JCOIN)
End HIV Epidemic (EHE)
HIV Services
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: South Bay House of Corrections
name: Nashua Street Jail
First posted: 2024-11-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are currently incarcerated in either South Bay Correctional Facility or Nashua Street Jail. To be considered eligible they must have opioid use disorder (OUD), be older than 18 years of age, and by self-report say that they will be released from the jail within about one month of the day of study enrollment.

Brief summary: This pilot feasibility study represents part 3 of a larger R61 study, where the investigators will follow a cohort about their experiences with human immunodeficiency virus (HIV) testing.

This project aims to assess the effectiveness of an intervention at two jail sites in the Boston area: South Bay House of Corrections and Nashua Street Jail implemented in January of 2025 that is aimed at improving HIV testing practices and HIV treatment in those carceral facilities. This implementation was developed independently of the investigators' study activities. The jails worked to develop changes in their electronic health record to offer HIV testing at various points in their intake and physical exam process. HIV care was not well-integrated with the jails' existing intake and healthcare administration systems and medications for opioid use disorder (MOUD) program. The investigators will evaluate the intervention the jails developed to address these issues. The outcomes of interest are more implementation than effectiveness outcomes.

The primary goal of this study is to identify existing barriers in the carceral healthcare setting that prevent the improvement of HIV testing and treatment.


Eligibility criteria: Inclusion Criteria:

* Incarcerated at South Bay House of Corrections or Nashua Street Jail
* Participant Report that they will be leaving jail within 1 month.
* Participant must be comfortable speaking in the English Language
* Has Opioid Use Disorder (OUD) indicated by participation in Medications for Opioid Use Disorder (MOUD) program and/or self-report

Exclusion Criteria:

* Cognitive ability that prevents obtained consent or completion of study activities (defined through Research Assistant (RA) determination)

Primary outcomes:
measure: Number of participants that use HIV services while incarcerated
timeFrame: on average 4-6 weeks
measure: Number of participants that use of PrEP if HIV negative
timeFrame: 1 week, 3 months post incarceration
measure: Number of participants that have HIV testing in the community if unknown status during incarceration
timeFrame: 1 week, 3 months post incarceration
Secondary outcomes:
measure: Number of participants that demonstrate HIV knowledge
timeFrame: 1 week, 3 months post incarceration
measure: Number of participants that have Risk Behaviors for HIV
timeFrame: 1 week, 3 months post incarceration
measure: Number of participants that have substance use
timeFrame: 1 week, 3 months post incarceration
measure: Number of participants with Sexually Transmitted infections (STIs)
timeFrame: 1 month, 3 months post incarceration
measure: Number of participants with PrEP Awareness
timeFrame: 1 week, 3 months post incarceration
measure: Number of participants with acute healthcare utilization
timeFrame: 1 week, 3 months post incarceration
Other outcomes:
Locations:
Study officials:
affiliation: BU Chobanian & Avedisian School of Medicine
name: Alysse Wurcel, MD MS
role: PRINCIPAL_INVESTIGATOR
References: