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N/A N=31 Randomized Other

HIV+ Substance Users Released From Jail

HIV/AIDS · Substance Use Disorders

Enrolled (actual)
31
Serious AEs
58.1%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participants With Undetectable HIV Viral Load — 2; 3 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
DOORS-CHW Intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Apr 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Undetectable HIV Viral Load
2; 3
SECONDARY
Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen
4; 8; 5; 1

Summary

The long-term goal of this project is to improve HIV and substance use outcomes and reduce recidivism for HIV+ substance users released from jail. The overall objective of the proposed R34 project is to develop and pilot test a multi-sector community-clinic collaborative intervention that can subsequently be implemented on a larger scale (as part of a future R01) to achieve this goal. Our central hypothesis is that HIV+ substance users released from jail can successfully overcome obstacles to re-entry and continuity of HIV care with individualized, culturally competent assistance in navigating both social and medical services. Aim 1: Develop and refine a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Aim 2: Conduct a pilot randomized controlled trial comparing the collaborative intervention (n=40) compared to treatment as usual (n=40) in HIV+ substance users released from jail.

Eligibility Criteria

Inclusion Criteria

  • HIV-infected AND
  • ≥18 years old AND
  • report or have medical records documenting any opioid (illicit or prescription misuse), stimulant (cocaine, ecstasy, or amphetamines), or heavy alcohol use (as determined by the 3-item Alcohol Use Disorders Identification Test (AUDIT-C) within the past 12 months
  • Provide two forms of contact information (address, phone number, email, other locator info) AND
  • HIV VL >200 copies/mL within past 90 days OR
  • No HIV visit in 6 months OR Self-reported non-adherence to medications

Exclusion Criteria

  • Unwilling to participate
  • Unable to consent
  • Does not speak English
  • Unwilling to participate
  • Unable to consent
  • Does not plan to remain in greater Dallas area after release Sentenced to prison or other court-mandated program for ≥6 months
  • Does not speak English
  • Have an acute medical or psychiatric disorder that would, in the judgment of the PI, make participation difficult or unsafe.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03834779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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