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RECRUITING Phase 4

Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women

NCT05547048 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ). This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.

Interventions

  • BEHAVIORAL Decision Aid
  • COMBINATION_PRODUCT Athena strategy

Study Locations (2)

Alabama

  • University of Alabama in Birmingham — Birmingham

Connecticut

  • Yale University — New Haven

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2023-07-25
Est. Completion 2027-04-01
Phase Phase 4

Sponsor

Yale University

1,283 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05547048

The ClinicalTrials.gov registry entry for NCT05547048 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions — of which Decision Aid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05547048 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Alabama, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05547048 about?

NCT05547048 is a clinical study titled "Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women". The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ). This study evaluates a newly validated PrEP decision ai...

What is the current status of trial NCT05547048?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2023-07-25. Estimated completion is 2027-04-01.

What conditions does trial NCT05547048 study?

This clinical trial studies the following conditions: HIV, Opioid Use Disorder, eHealth. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05547048?

The interventions under investigation include: Decision Aid (BEHAVIORAL), Athena strategy (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05547048?

This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05547048 being conducted?

This trial has 2 study locations across Alabama, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial