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Recruiting NCT07223398

Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)

No phase Interventional Substance Use Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard PN, Patient Choice.
Who it may be relevant to
Registry conditions: Substance Use Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations

Overview

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.

Detailed description

This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.

The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.

Interventions

  • Behavioral Standard PN
    Standard of care
  • Behavioral Patient Choice
    Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Primary outcome measures

  • Percentage of participants who initiate or re-initiate PrEP [Time frame: 6 months]
  • Percentage of participants who initiate or re-initiate ART [Time frame: 6 months]
Secondary outcome measures (12)
  • Percentage of participants that adhere to PrEP [Time frame: 6 and 12 months]
  • Percentage of participants retaining on PrEP [Time frame: 6 and 12 months]
  • HIV incidence [Time frame: 6 and 12 months]
  • Percentage of participants that adhere to ART [Time frame: 6 and 12 months]
  • ART retention [Time frame: 6 and 12 months]
  • Substance use treatment [Time frame: 6 and 12 months]
  • HIV viral suppression [Time frame: 6 months]
  • Retention in HIV PrEP/ART [Time frame: 6 months]
  • Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior [Time frame: 6 and 12 months]
  • Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior [Time frame: 6 and 12 months]
  • Days of using opioids [Time frame: 6 and 12 months]
  • Number of participants with with overdose events [Time frame: 6 and 12 months]

Eligibility criteria

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 12 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 in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 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 in the last 12 months within the community.

Exclusion criteria

  • severe medical or psychiatric disability making participation unsafe;
  • unable to provide consent.
  • persons self-reporting pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Yale School of Medicine — New Haven
  • College of Medicine at the University of Kentucky — Lexington
  • University of Texas Southwestern Medical Center (UTSW) — Dallas
  • Texas Christian University's (TCU) School of Medicine — Fort Worth

Identifiers

NCT: NCT07223398 · 2000037052_a · 4R33DA060625-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗