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Giving people a choice in HIV care may boost treatment uptake after jail

NCT ID NCT06439329

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests two approaches to help people recently involved with the justice system start HIV prevention or treatment and substance use care. One group gets standard patient navigation; the other can choose from a menu of services including in-person clinics, a mobile health unit, or telehealth. Researchers will measure how many people begin PrEP, ART, or substance use treatment, and whether offering choices improves engagement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patient navigation with a choice of community-based health services (brick-and-mortar, mobile health unit, or telehealth)
What this could lead to
If successful, this could show that offering a choice of how to receive care helps more people with justice involvement start and stay on HIV prevention or treatment and substance use treatment.
What could go wrong
This is a small, early feasibility study with only 40 participants, so results may not apply broadly. It measures attitudes and service use, not health outcomes like HIV transmission or viral suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * able to provide written informed consent in English or Spanish; * living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well); * Those with current justice involvement (with in the past 6 months) (e.g., prison, jail, community supervision); * willing to have HIV testing to determine negative or positive status; * persons with HIV who report not currently taking ART and have a viral load \>200 copies/mL in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and; * Having a history of opioid and/or stimulant use within 12 months prior to being in a controlled setting and/or in the last 6 months within the community Implementation portion/CAB members: * able to provide written informed consent in English or Spanish; * working with persons with a history of justice involvement and substance use in the areas targeted for this project PN Participants: * able to provide written informed consent in English or Spanish; * be employed at a project research site as a Patient Navigator Exclusion Criteria: * severe medical or psychiatric disability making participation unsafe; * unable to provide consent. * persons self-reporting pregnancy Implementation portion/CAB members: * persons self-reporting pregnancy

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Conditions

The condition(s) this trial relates to.

HIV infectious disease substance-related disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Substance use disorders

Contacts and locations

Locations

  • 135 College St., Suite 280

    New Haven, Connecticut, 06510, United States

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