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New eHealth tool aims to cut HIV and opioid risks for Justice-Involved women

NCT ID NCT05547048

Prevention 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a digital health program to help women involved in the criminal justice system start PrEP (a daily pill to prevent HIV) and get treatment for opioid use disorder. Researchers will compare the program to a simpler decision aid alone. The goal is to reduce stigma and improve access to care for 250 women in Connecticut and Alabama.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

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

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * woman * have access to a working mobile or landline phone * Lifetime CJ-involvement (probation, parole, intensive pretrial or community supervision, or release from prison/jail) * are confirmed HIV-negative by point-of-care 3rd generation HIV antibody test * meet clinical criteria for PrEP * have opioid use disorder (regardless of baseline treatment status) Exclusion Criteria: * unable or unwilling to provide informed consent * pregnant or breast-feeding * currently taking PrEP at the time of study enrollment * not comfortable conversing in English or Spanish.

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Conditions

The condition(s) this trial relates to.

opiate dependence HIV infectious disease prevention target

As listed by the trial registrant

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

Ehealth HIV Opioid-use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Alabama in Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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