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Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)
NCT07223398 · View on ClinicalTrials.gov ↗
Study Summary
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
Conditions Studied
Interventions
- BEHAVIORAL Standard PN
- BEHAVIORAL Patient Choice
Study Locations (4)
Texas
- University of Texas Southwestern Medical Center (UTSW) — Dallas
- Texas Christian University's (TCU) School of Medicine — Fort Worth
Connecticut
- Yale School of Medicine — New Haven
Kentucky
- College of Medicine at the University of Kentucky — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-11-24 |
| Est. Completion | 2028-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07223398
The ClinicalTrials.gov registry entry for NCT07223398 describes a study currently listed as recruiting. It is categorized as NA, 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 400 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 1 condition, with Substance Use Disorders appearing as the primary indexed condition, and to 2 interventions — of which Standard PN 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: NCT07223398 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Texas, Connecticut, Kentucky. 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 NCT07223398 about?
NCT07223398 is a clinical study titled "Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)". This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the ...
What is the current status of trial NCT07223398?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2025-11-24. Estimated completion is 2028-06.
What conditions does trial NCT07223398 study?
This clinical trial studies the following conditions: Substance Use Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07223398?
The interventions under investigation include: Standard PN (BEHAVIORAL), Patient Choice (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07223398?
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 NCT07223398 being conducted?
This trial has 4 study locations across Connecticut, Kentucky, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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