NCT06679751

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

November 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

November 4, 2024

Last Update Submit

July 28, 2026

Conditions

Keywords

Carceral systemHIV testingPre-exposure prophylaxis (PrEP)Justice Community Opioid Innovation Network (JCOIN)End HIV Epidemic (EHE)HIV Services

Outcome Measures

Primary Outcomes (3)

  • Number of participants that use HIV services while incarcerated

    This will be assessed from a review of information abstracted from study questionnaires and interviews with study staff and recorded as a binary 'Yes or No'. If there is any mention of HIV services of any type such as testing, obtaining information. or counseling related to HIV while incarcerated, the participant will be categorized as using HIV services/Yes.

    on average 4-6 weeks

  • Number of participants that use of PrEP if HIV negative

    This will be assessed from a review of information abstracted from study questionnaires and interviews with study staff and recorded as a binary 'Yes or No'. For participants who are HIV negative, if there is any mention of PrEP being used the participant will be categorized as using PrEP/Yes.

    1 week, 3 months post incarceration

  • Number of participants that have HIV testing in the community if unknown status during incarceration

    This will be assessed from a review of information abstracted from study questionnaires and interviews with study staff and recorded as a binary 'Yes or No'. Participants with unknown HIV status during incarceration who are tested for HIV in the community, will be categorized as Yes.

    1 week, 3 months post incarceration

Secondary Outcomes (6)

  • Number of participants that demonstrate HIV knowledge

    1 week, 3 months post incarceration

  • Number of participants that have Risk Behaviors for HIV

    1 week, 3 months post incarceration

  • Number of participants that have substance use

    1 week, 3 months post incarceration

  • Number of participants with Sexually Transmitted infections (STIs)

    1 month, 3 months post incarceration

  • Number of participants with PrEP Awareness

    1 week, 3 months post incarceration

  • +1 more secondary outcomes

Study Arms (1)

ID-TOUCH Program

Participants will receive the ID-TOUCH intervention while incarcerated and meet with the study team three times for data collection: once before release, once one week after release, and once three months after release. Information collected will include: utilization of HIV services while in jail and while in the community and an exploration of self-reported high-risk behavior, perceived stigma and discrimination, and medical mistrust.

Behavioral: ID-TOUCH

Interventions

ID-TOUCHBEHAVIORAL

ID TOUCH is a multi-pronged intervention to increase HIV testing and PrEP linkage that includes jail-based HIV care process improvements with post-incarceration outreach and linkage to community services.

ID-TOUCH Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Bay House of Corrections

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

HIV InfectionsOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alysse Wurcel, MD MS

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 7, 2024

Study Start

June 23, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations