HIV+ Substance Users Released From Jail

NCT03834779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-02-13

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

DOORS-CHW Intervention

The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Ank E Nijhawan, M.D. · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2021-04-29
Completion
2021-08-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834779 on ClinicalTrials.gov