HIV+ Substance Users Released From Jail
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03834779|
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 11, 2019
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- HIV viral load [ Time Frame: At 6 months after enrollment ]Proportion of individuals with an undetectable viral load (<200 copies/mL)
- Substance use- biological testing [ Time Frame: At 6 months after enrollment ]Substance use as measured by urine toxicology screen
- 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;
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+);
- Recidivism [ Time Frame: From enrollment to 12 months after enrollment ]Re-incarceration in jail or prison
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
|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|
|Principal Investigator:||Ank E Nijhawan, M.D.||University of Texas Southwestern Medical Center|