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 : April 1, 2019
|First Submitted Date ICMJE||February 5, 2019|
|First Posted Date ICMJE||February 8, 2019|
|Last Update Posted Date||April 1, 2019|
|Estimated Study Start Date ICMJE||May 1, 2019|
|Estimated Primary Completion Date||December 2020 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||HIV viral load [ Time Frame: At 6 months after enrollment ]
Proportion of individuals with an undetectable viral load (<200 copies/mL)
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03834779 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Substance use- biological testing [ Time Frame: At 6 months after enrollment ]
Substance use as measured by urine toxicology screen
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures
|Original Other Pre-specified Outcome Measures
|Brief Title ICMJE||HIV+ Substance Users Released From Jail|
|Official Title ICMJE||A Community-Clinic Collaboration to Improve Outcomes in HIV+ Substance Users Released From Jail|
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.
Aim 1 Introduction: This first aim will be critical to successful implementation of the CHW-DOORS intervention. Employing a formerly incarcerated CHW to assist individuals leaving prison in order to connect to healthcare has been successfully implemented in different settings, but it has not been applied specifically to HIV patients or those leaving jail (v. prison), nor has it been integrated into a community based organization. The objective of this aim is to adapt the evidence-based CHW intervention to the HIV population and to the jail setting and to integrate the CHW into existing processes at DOORS and the outpatient HIV clinic system.
Research Design. Aim 1.1: The first step of Aim 1 will be to train the CHW using the transitions clinic approach, add modules on HIV and substance use and familiarize the CHW with DOORS processes and HIV clinic workflow.
Aim 1.2: The second step will be to complete qualitative interviews with stakeholders in three different settings- the jail, the HIV clinic and DOORS. All interviews will be semi-structured, one-on-one interviews, with an estimated 4-7 interviews in each setting.
The structured component of the interview guide will prompt interviewee input on study design (e.g. recruitment, intervention, follow-up visits), content of the intervention (e.g. high demand services) and an open-ended component eliciting possible barriers to study implementation.
Aim 1.3: The final step in Aim 1 will be to complete pilot testing with 5 subjects, which will focus on refining recruitment/enrollment protocols, streamlining study assessments and evaluating the intervention.
Recruitment: In order to protect patient confidentiality, potential subjects will be referred by medical staff who provide clinical care to HIV+ inmates. When an inmate enters the Dallas County Jail, he/she is evaluated by a medical provider within 24 hours (medical assessment program, MAP). At this visit, the inmate can disclose any medical conditions that they have including HIV, in which case he/she will be referred to the jail HIV clinic (scheduled within 1-7 days of jail entry). In addition, HIV testing is offered in an opt-out manner when inmates have blood drawn for any reason (approximately 10% of jail population) and by inmate request, and those with positive test results are referred to jail HIV clinic. Candidates coming through the MAP or HIV clinics who agree to be approached will be contacted by a research assistant (RA). The RA will explain the study to interested individuals, will obtain additional contact information (additional phone numbers, address or location in community where patient could be found) and permission to contact the individual after release. Clinic staff will also routinely request this information from interested individuals in case they are released prior to RA visit in jail. Once released, the research team will contact the individual releasee to schedule an enrollment visit. At this visit, which will occur as soon as possible after jail release (maximum within 30 days of release), the research team will obtain informed consent and enroll the participant into the study. The enrollment may occur at the UT Southwestern HIV research unit (located above the main HIV clinic) or in the community as per participant preference.
Enrollment: In order to be enrolled, individuals must (a) be ≥18 years old, (b) have a confirmed diagnosis of HIV, (c) have evidence of uncontrolled HIV (viral load >200 copies/mL within 90 days of enrollment, self-reported non-adherence to HIV medications or no community clinic visit in the 6 months preceding incarceration), (d) 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, and (e) provide at least 2 forms of contact information. They will also be asked to provide a release of information for their medical records at the jail and community clinics/ hospitals. No randomization will occur in Aim 1 as all 5 participants in the pilot testing phase will be assigned to the intervention. Baseline assessments will occur after informed consent is obtained and enrollment is complete. These assessments will focus on variables in the conceptual model, with collection of demographics (age, race/ethnicity, gender, HIV risk factor) and social variables (marital status, housing, education, employment/income, insurance, benefits, social support). Subjects will also be asked about HIV care (engagement in care, antiretroviral therapy, adherence to medications (using visual analog scale), barriers to care), mental illness, and substance use (using ASSIST questionnaire).
Intervention: The first meeting with the CHW will occur at the time of enrollment if possible, depending on availability of the participant and CHW, otherwise it may occur anytime within 14 days of enrollment. After release from jail, the CHW will help the participant navigate to DOORS, where they will meet with a "broker", someone who helps the client/participant arrange and negotiate referrals to services within the extensive partner/provider network. The first broker meeting will typically occur within 2-4 weeks after release, as this is a critical window for re-engagement in care, underscored by the fact that this is also a high-risk period for increased unprotected sex and return to substance use. Per DOORS' standard practice, the broker will complete a comprehensive needs assessment with the participant. Based on these assessments, together with the participant, the broker will develop a personalized re-entry plan with a detailed list of referrals and calendar of scheduled visits with relevant agencies within the DOORS network.
Follow-up visits and assessments: Research visits will be scheduled at 3 months, 6 months and 12 months. A 4-week window before and 8-week window after the target follow-up dates will be permitted for study assessments. Assessments will be completed at each follow-up visit, including substance use, adherence, healthcare utilization and recidivism, with blood draw for HIV viral load collected at the 6-month visit. In order to maximize efficient utilization of resources, for baseline and other follow-up visits, HIV viral load will be abstracted from medical records. In order to have sufficient time to enroll and complete 12 month study visits for the 80 participants in Aim 2, the 5 pilot participants from Aim 1.3 need to reach at least the 3 month time point but not 6 or 12-month visits before beginning study enrollment for Aim 2. Pilot participants will complete through 12-month visits as this will provide insight as to how best to conduct these later follow-up visits. All participants will receive financial reimbursement for study visits ($25 for each visit), unless they are incarcerated at the time of the visit. Jail inmates are not permitted to receive any financial incentives during incarceration.
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.
Introduction. In this aim, we will test the CHW-DOORS intervention that was refined in Aim 1 in a randomized fashion. The goal of this aim is to establish feasibility of a randomized controlled trial in this setting, to determine preliminary efficacy of the intervention and to inform sample size calculations for a fully powered trial. In addition, this aim will provide data regarding key factors involved in HIV+ substance users accessing substance use treatment and HIV care after jail release. Our working hypothesis is that from the stakeholder input and pilot testing completed in Aim 1, we will be able to successfully conduct a pilot randomized controlled trial and gain valuable insight into key predisposing and enabling factors influencing healthcare needs and utilization in this population, and how these may impact HIV viral load, substance use and recidivism.
Research Design. Potential participants will be referred to the research study by Dallas County jail medical providers as described in Aim 1.3. Candidates who agree to be approached will be contacted by a RA who will recruit, and review eligibility criteria (see Aim 1.3). After release, potential participants will be contacted in order to complete informed consent, study enrollment and randomization (to be completed within 30 days of release from jail). All participants will provide 2 specific forms of locator information (telephone number for themselves, friend/family member, address, email, specific location where they may be located to aid in retention efforts). Participants will complete baseline assessments and will then be randomized to the intervention CHW-DOORS versus treatment as usual (TAU). Randomization will occur by random assignment using a computer program, without block randomization given the small sample size. TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
Intervention. Participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS as outlined in Aim 1.3. Any modifications to this protocol after pilot testing in Aim 1.3 will be implemented in Aim 2. The general premise will be the same, where the DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. The measurement of the intervention will be as noted in Aim 1.3, with the DOORS broker following routine agency processes for referrals and measurement using the PIECES technology program and the CHW will record specifics (where, when, duration) of each visit and what was addressed during these intervention visits.
Study Assessments. All participants will complete baseline assessments prior to randomization and will have follow-up visits at 3, 6 and 12 months as noted in Aim 1.3. A blood draw will be performed for 6-month HIV viral load. Follow-up visits will assess HIV viral load (abstracted from medical record for all visits other than 6 month), substance use (using ASSIST), healthcare utilization including attendance of HIV clinic visits, emergency room visits, hospitalizations and reincarceration. If individuals are reincarcerated at the Dallas County Jail at the time of the follow-up visits, an attempt will be made to complete study visits at the jail.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
|Intervention ICMJE||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).
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||March 31, 2021|
|Estimated Primary Completion Date||December 2020 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years to 89 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT03834779|
|Other Study ID Numbers ICMJE||STU 082017-022
1R34DA045592-01 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Ank Nijhawan, University of Texas Southwestern Medical Center|
|Study Sponsor ICMJE||University of Texas Southwestern Medical Center|
|PRS Account||University of Texas Southwestern Medical Center|
|Verification Date||March 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP