- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06679751
Infectious Disease (ID) Testing OUtreach in Carceral Hubs (ID-TOUCH)
Massachusetts HIV and Justice Involved Populations Research Network
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alysse Wurcel, MD MS
- Phone Number: 617-414-5951
- Email: Alysse.Wurcel@bmc.org
Study Contact Backup
- Name: Brindet Socrates, BS
- Phone Number: 617-414-5951
- Email: brindet.socrates@bmc.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Recruiting
- South Bay House of Corrections
-
Contact:
- Alysse Wurcel, MD MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants that use HIV services while incarcerated
Time Frame: on average 4-6 weeks
|
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
Time Frame: 1 week, 3 months post 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'.
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
Time Frame: 1 week, 3 months post 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants that demonstrate HIV knowledge
Time Frame: 1 week, 3 months post 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 who demonstrate HIV knowledge will be categorized as Yes.
|
1 week, 3 months post incarceration
|
|
Number of participants that have Risk Behaviors for HIV
Time Frame: 1 week, 3 months post 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 who have rsk behaviors for HIV will be categorized as Yes.
|
1 week, 3 months post incarceration
|
|
Number of participants that have substance use
Time Frame: 1 week, 3 months post 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 who report they use substances [eg smoking cigarettes, drinking alcohol, or using any illicit drugs] will be categorized as Yes.
|
1 week, 3 months post incarceration
|
|
Number of participants with Sexually Transmitted infections (STIs)
Time Frame: 1 month, 3 months post 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 who report that they were tested and told they have any STI other than HIV [eg syphilis, gonorrhea, hepatitis C virus (HCV)] will be categorized as Yes.
|
1 month, 3 months post incarceration
|
|
Number of participants with PrEP Awareness
Time Frame: 1 week, 3 months post 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 who demonstrate awareness about PrEP will be categorized as Yes.
|
1 week, 3 months post incarceration
|
|
Number of participants with acute healthcare utilization
Time Frame: 1 week, 3 months post 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 who report they were either hospitalized or received care in an emergency room will be categorized as Yes.
|
1 week, 3 months post incarceration
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alysse Wurcel, MD MS, Boston Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-45426
- 1R61DA060588-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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