HIV+ Substance Users Released From Jail
Condition: HIV/AIDS; Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): DOORS-CHW Intervention
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV; AIDS; Substance Use