HIV InfectionsID-TOUCHNCT06679751
Infectious Disease (ID) Testing OUtreach in Carceral Hubs
An observational study of HIV Infections and Opioid Use Disorder, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Opioid Use Disorder
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cognitive ability that prevents obtained consent or completion of study activities (defined through Research Assistant (RA) determination)
Trial locations and contacts
1 site in 1 country.
United States1 site
South Bay House of Corrections
Boston, Massachusetts, 02118
About this study
Official title: 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.
- 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
- Medical subject headings
- HIV Infections, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 week, 3 months post incarceration
Secondary outcomes (6)
Number of participants that demonstrate HIV knowledge
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.
Measured: 1 week, 3 months post incarceration
Number of participants that have Risk Behaviors for HIV
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.
Measured: 1 week, 3 months post incarceration
Number of participants that have substance use
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.
Measured: 1 week, 3 months post incarceration
Number of participants with Sexually Transmitted infections (STIs)
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.
Measured: 1 month, 3 months post incarceration
Number of participants with PrEP Awareness
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.
Measured: 1 week, 3 months post incarceration
Number of participants with acute healthcare utilization
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.
Measured: 1 week, 3 months post incarceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start23 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), South Bay House of Corrections, Nashua Street Jail
- Responsible party
- Sponsor
- Investigators
- Alysse Wurcel, MD MS, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679751
- Sponsor's protocol ID
- H-45426
- Other IDs
- 1R61DA060588-01
- Acronym
- ID-TOUCH
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massachusetts HIV and Justice Involved Populations Research Network
- ClinicalTrials.gov ID
- NCT06679751
- Acronym / sponsor ID
- ID-TOUCH / H-45426
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), South Bay House of Corrections, Nashua Street Jail
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive ability that prevents obtained consent or completion of study activities (defined through Research Assistant (RA) determination)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
6 secondary outcomes
Number of participants that demonstrate HIV knowledge
Time frame: 1 week, 3 months post incarceration
Number of participants that have Risk Behaviors for HIV
Time frame: 1 week, 3 months post incarceration
Number of participants that have substance use
Time frame: 1 week, 3 months post incarceration
Number of participants with Sexually Transmitted infections (STIs)
Time frame: 1 month, 3 months post incarceration
Number of participants with PrEP Awareness
Time frame: 1 week, 3 months post incarceration
Number of participants with acute healthcare utilization
Time frame: 1 week, 3 months post incarceration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alysse Wurcel, MD MS principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Opioid Use Disorder, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that use HIV services while incarcerated (time frame: on average 4-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.