Infectious Disease (ID) Testing OUtreach in Carceral Hubs (ID-TOUCH)

July 28, 2025 updated by: Boston Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • South Bay House of Corrections
        • Contact:
          • Alysse Wurcel, MD MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
South Bay House of Corrections
Nashua Street Jail

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alysse Wurcel, MD MS, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-45426
  • 1R61DA060588-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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