HIV+ Substance Users Released From Jail

NCT03834779 | Completed Results DMC

• 2 other identifiers: STU 082017-0221R34DA045592-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS; Substance Use Disorders

Keywords

HIV; AIDS; Substance Use

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Undetectable HIV Viral Load

  Number of participants with an undetectable HIV viral load (\<200 copies/mL) is assessed via blood work.

  At 6 months after enrollment

Secondary Outcomes (1)

• Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen

  At 6 months after enrollment

Other Outcomes (2)

• Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire

  Baseline and 6 months after enrollment

• Number of Participants Who Experienced Recidivism

  at 12 months after enrollment

Study Arms (2)

DOORS-CHW Intervention

OTHER

The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.

Behavioral: DOORS-CHW Intervention

Treatment As Usual

NO INTERVENTION

TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.

Interventions

DOORS-CHW Intervention BEHAVIORAL

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).

DOORS-CHW Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Amelia Court, HIV Research Unit

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Limitations: This study (1) was initiated just before the COVID-19 pandemic which limited recruitment and decreased opportunities for in-person interaction between participants and staff. However, efforts were made to connect with participants outdoors or through virtual methods whenever possible. (2) is a single center study localized in a large Southern city with a focus on both substance use - primarily stimulants - and HIV and therefore may not be applicable to other locations/populations.

Results Point of Contact

• Title: Dr. Ank Nijhawan
• Organization: UT Southwestern Medical Center

ank.nijhawan@utsouthwestern.edu

214-648-2777

Study Officials

• Ank E Nijhawan, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 8, 2019
• Study Start: May 29, 2019
• Primary Completion: April 29, 2021
• Study Completion: August 25, 2021
• Last Updated: February 13, 2023
• Results First Posted: February 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)