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HIV+ Substance Users Released From Jail

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ClinicalTrials.gov Identifier: NCT03834779
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ank Nijhawan, University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Substance Use Disorders Behavioral: DOORS-CHW Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Community-Clinic Collaboration to Improve Outcomes in HIV+ Substance Users Released From Jail
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
DOORS-CHW Intervention

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

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).


No Intervention: Treatment As Usual
TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.



Primary Outcome Measures :
  1. HIV viral load [ Time Frame: At 6 months after enrollment ]
    Proportion of individuals with an undetectable viral load (<200 copies/mL)


Secondary Outcome Measures :
  1. Substance use- biological testing [ Time Frame: At 6 months after enrollment ]
    Substance use as measured by urine toxicology screen


Other Outcome Measures:
  1. Substance use- questionnaire [ Time Frame: From enrollment to 6 months after enrollment ]

    Change in ASSIST (World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test v3.1) score from baseline to 6 months. For the participant's reported drug of choice, the score on the relevant subscale will be used: (A) ASSIST risk score for tobacco (range 0-31); (B) alcohol (range 0-39); (C) cannabis (range 0-39); (D) cocaine (range 0-39); (E) amphetamine-type stimulants (range 0-39); (F) inhalants (range 0-39); (G) for sedatives or sleeping pills (range 0-39); (H) hallucinogens (range 0-39); (I) opioids (range 0-39); (J) 'other' drugs (range 0-39); High values indicate a worse outcome. Subscales are not combined;

    Score interpretation:

    Lower Risk: Alcohol (0-10), All other substances (0-3); Moderate Risk: Alcohol (11-26), All other substances (4-26); High risk: Alcohol (26+), All other substances (27+);


  2. Recidivism [ Time Frame: From enrollment to 12 months after enrollment ]
    Re-incarceration in jail or prison



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834779


Contacts
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Contact: Ank E Nijhawan, M.D. 214-648-2777 Ank.Nijhawan@UTSouthwestern.edu
Contact: Laura A Hansen, M.A. 214-590-0608 Laura.Hansen@UTSouthwestern.edu

Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ank E Nijhawan, M.D. University of Texas Southwestern Medical Center

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Responsible Party: Ank Nijhawan, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03834779     History of Changes
Other Study ID Numbers: STU 082017-022
1R34DA045592-01 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ank Nijhawan, University of Texas Southwestern Medical Center:
HIV
AIDS
Substance Use

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders