xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027671</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00386911</org_study_id>
      <nct_id>NCT06027671</nct_id>
    </id_info>
    <brief_title>Structured Peer-delivered ART and Reentry Community Strategy</brief_title>
    <acronym>SPARCS</acronym>
    <official_title>Structured Peer-delivered Antiretroviral Therapy (ART) and Reentry Community Strategy to Overcome Barriers to HIV Care Continuity During Community Re-entry From Incarceration in South Africa</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aurum Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Seoul National University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overarching goal of this study is to implement both a transition community adherence club&#xD;
        strategy (Group-SPARCS) and an ART provision strategy (ART-SPARCS) for HIV-positive&#xD;
        individuals transitioning from correctional to community settings in South Africa. The&#xD;
        current proposal will allow for a fully powered effectiveness randomized clinical trial&#xD;
        (RCT).&#xD;
  &#xD;
          -  To compare the effectiveness of Full-SPARCS, ART-SPARCS, and Group-SPARCS to care as&#xD;
             usual and to each other to achieve HIV RNA suppression 6 months following correctional&#xD;
             facility release&#xD;
  &#xD;
          -  To assess determinants of implementation of Full-SPARCS, ART-SPARCS, and Group-SPARCS.&#xD;
  &#xD;
          -  To assess the scalability through costing and cost effectiveness analysis of&#xD;
             Full-SPARCS, ART-SPARCS, and Group-SPARCS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The South African government has devoted resources towards HIV care in&#xD;
        correctional facilities that have resulted in antiretroviral therapy (ART) coverage of &gt;90%&#xD;
        and viral load (VL) suppression of &gt;80% among incarcerated people living with HIV (PLWH).&#xD;
        However, despite free post-release care, the investigators previously observed that only an&#xD;
        estimated 34% were in care three months post-release. The investigators developed, tested,&#xD;
        and manualized the Structured Peer-delivered ART and Re-entry Community Strategy (SPARCS) to&#xD;
        overcome post-incarceration barriers specific to PLWH returning to the community.8-10 In the&#xD;
        investigators randomized controlled pilot of SPARCS, 6-month post-release, continuity of care&#xD;
        was 61% in the intervention arm compared to 36% in the usual care arm (p=0.001),&#xD;
        demonstrating effectiveness. Full-SPARCS, has two distinct components spanning six months&#xD;
        post-release: direct provision of ART (ART-SPARCS) and 12 biweekly peer facilitator-led group&#xD;
        sessions (Group-SPARCS). ART-SPARCS is designed to overcome clinic-level barriers through&#xD;
        bimonthly distribution of ART without a group component. Group-SPARCS is designed to increase&#xD;
        self-efficacy, social support, and life skills through facilitated group discussion and&#xD;
        curriculum including planning, problem solving, financial literacy, and living with HIV&#xD;
        without ART distribution. The current usual care is a supply of ART and a referral letter at&#xD;
        the time of release from incarceration.&#xD;
  &#xD;
        Methods: This research study will be conducted in Gauteng Province. Recruitment will occur&#xD;
        within correctional facilities of the Department of Correctional Services (DCS) - Modderbee,&#xD;
        Kgosi Mampuru II, and Johannesburg. All study interventions will occur following release in&#xD;
        either Ekurhuleni District, Tshwane District or Johannesburg District. The study population&#xD;
        will be comprised of adult (≥18 years old) corrections inmates, either male or female, with&#xD;
        known HIV infection and are receiving ART within the correctional facility and are expected&#xD;
        to be released back into the community within 3 months of study enrollment Participants will&#xD;
        be randomized 1:1:1:1 to either the standard of care, Full-SPARCS, Group-SPARCS, or&#xD;
        ART-SPARCS using sequential envelopes with study arm determination sealed inside. Study staff&#xD;
        will contact participants to ascertain care status and update contact information at one&#xD;
        week, one month, three months, six months, nine months, and twelve months from release.&#xD;
        Participants assigned to Group-SPARCS or ART-SPARCS will be asked to attend biweekly&#xD;
        sessions. Group-SPARCS activities will include - structured curriculum, symptom screening,&#xD;
        and routine laboratory monitoring. ART-SPARCS will include the distribution of pre-packed&#xD;
        medication and routine laboratory monitoring. Full-SPARCS includes all components of&#xD;
        Group-SPARCS and ART-SPARCS.&#xD;
  &#xD;
        Study sample: A total of 640 participants will be randomized to one of the four arms. Sixty&#xD;
        of the participants will be selected for participation in qualitative in-depth interviews. An&#xD;
        additional 25 staff involved in Transition community adherence club (TCAC) referral, ART&#xD;
        provision, implementation, coordination will be enrolled for qualitative in-depth interviews.&#xD;
  &#xD;
        Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research&#xD;
        and the South African National Strategic Plan on HIV, Tuberculosis (TB), and Sexually&#xD;
        Transmitted Infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research&#xD;
        Priority of &quot;retention and engagement in these services, and achievement and maintenance of&#xD;
        optimal prevention and treatment responses.&quot; It also addresses &quot;health disparities&quot; through a&#xD;
        focus on recently released inmates, a marginalized population. The proposal also fits with&#xD;
        the South African National Strategic Plan prioritizing inmates as a key population for HIV&#xD;
        services.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">August 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>This is a hybrid type 1 effectiveness-implementation study with a factorial design to compare care as usual, Full-SPARCS, ART-SPARCS, or Group-SPARCS. We will recruit participants from correctional facilities in the Department of Correctional Services (DCS) Gauteng Region, South Africa. Study activities for the intervention arm will be delivered in community venues near to where participants live in Tshwane District, Ekurhuleni District, and City of Johannesburg.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>We will perform individual randomization blocked by the correctional facility. Study staff will open numbered envelopes with the allocation following enrolment. Participants will be randomized 1:1:1:1 to one of the study arms using sequential envelopes with study arm determination sealed inside. Randomization will be stratified by study site and by sex. The randomization lists for each site/sex combination will be generated through randomly permuted blocks of four and eight study assignments with an equal number of group assignments within each block. Study assignments will be masked to staff performing outcome assessments (in-person and telephonic interviews) and the investigators until all outcome data have been collected.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>HIV RNA (viral load) suppression at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>HIV RNA suppression will be defined as a viral load &lt;1000 copies/mL. Participants without viral load data will be assumed to have a viral load &gt;1000 c/mL.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>HIV RNA (viral load) suppression at 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>HIV RNA suppression will be defined as a viral load &lt;1000 copies/mL. Participants without viral load data will be assumed to have a viral load &gt;1000 c/mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-effectiveness</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Cost effectiveness will be measured by combining standardized data collection tools and an analytic framework developed from prior studies to document and classify resources used (e.g. direct human resources, consumables, capital assets) for all intervention-related activities from design, coordination, to direct delivery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants receiving ART at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Participants receiving ART by 6 months post-release.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants receiving ART at 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>Participants receiving ART by 12 months post-release.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">640</enrollment>
    <condition>Retention in Care</condition>
    <arm_group>
      <arm_group_label>Care-as-usual (CAU) arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Per DCS routine, at release, participants will receive a referral letter form the DCS health services and, in most cases, will be provided with a 28-day supply of ART.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-SPARCS intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Group-SPARCS component comprises one individual pre-release session, one individual post-release session, and 12 every-other-week (every two weeks) post-release group sessions extending six months post-release. Each session will be led by two trained individuals: a peer (history of criminal justice involvement and living with HIV) and a social worker.30 Within 14 days of release, participants will have one-on-one contact with a facilitator to update locator information, continue rapport building, review disclosure plans, provide a reminder of SPARCS logistics, and assign or remind the participant to a SPARCS group based on their location of residence and timing of release (depending on whether this occurred pre-release). Each Group-SPARCS meeting lasts approximately 2 hours, and the sessions occur in a private space in a community venue (e.g., community centre or church).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ART-SPARCS intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ART delivery will follow Department of Health (DoH) procedures for differentiated models of care, in particular the Community Adherence Club model. Similar to community adherence clubs, the ART provision in SPARCS will be affiliated with a 'home clinic&quot; that will provide ART supplies for the participants. Routine community adherence club activities include:&#xD;
  ART will be provided every two months from correctional facility release to 6 months post-release (months 2, 4, and 6). Participants with less than two months of ART at release will receive a top-off to reach two months. ART will be pre-packaged by the DoH &quot;home clinic&quot;, collected by the facilitators, and distributed to the participants. At the time of distribution, the facilitators will conduct a standard DoH differentiated care symptom screen. Participants who report specific symptoms will be referred to the &quot;home clinic&quot; for further assessment per routine with Community Adherence Clubs.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Full-SPARCS arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Full-SPARCS combines Group-SPARCS and ART-SPARCS with ART delivery during SPARCS group meetings.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Structured Peer-delivered ART and Reentry Community Strategy</intervention_name>
      <description>The intervention aims to circumvent clinic barriers by directly providing ART and build behavioral skills (planning, self-efficacy) through peer-facilitator led group sessions to improve care continuity following release from incarceration.</description>
      <arm_group_label>ART-SPARCS intervention arm</arm_group_label>
      <arm_group_label>Full-SPARCS arm</arm_group_label>
      <arm_group_label>Group-SPARCS intervention arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Incarcerated at one of the participating study enrolment sites, awaiting trial&#xD;
               (un-sentenced) and sentenced individuals.&#xD;
  &#xD;
            -  Diagnosed with HIV and ART at the time of enrolment.&#xD;
  &#xD;
            -  Anticipated release or trial date within three months of study enrolment.&#xD;
  &#xD;
            -  Self-report expected to reside in an unrestricted environment within Ekurhuleni,&#xD;
               Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of&#xD;
               the SPARCS intervention sites (i.e., within 20km, 45-minute travel time, or two local&#xD;
               taxi minibus rides)&#xD;
  &#xD;
            -  Willing to participate in study post-release follow-up activities and provide contact&#xD;
               information for post-release follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years of age.&#xD;
  &#xD;
            -  Condition (severe cognitive dysfunction or mental illness) rendering the individual&#xD;
               unable to provide informed consent.&#xD;
  &#xD;
            -  Unable to provide informed consent to participate in the study.&#xD;
  &#xD;
            -  Assessment by DCS health staff indicating that the individual requires a high&#xD;
               intensity of care exceeding that which can be provided in a differentiated model of&#xD;
               care setting.&#xD;
  &#xD;
            -  Not released from the correctional facility during the period of intervention&#xD;
               delivery.&#xD;
  &#xD;
            -  Release to a region outside of Gauteng.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christopher Hoffmann</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christopher Hoffmann</last_name>
      <phone>4106144257</phone>
      <email>choffmann@jhmi.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tonderai Mabuto</last_name>
      <email>tmabuto@auruminstitute.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Viral Load Suppression</keyword>
    <keyword>Prison</keyword>
    <keyword>Transition</keyword>
    <keyword>Care continuity</keyword>
    <keyword>HIV</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027671
  org study id: IRB00386911
  nct id: NCT06027671
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The overarching goal of this study is to implement both a transition community adherence club
        strategy (Group-SPARCS) and an ART provision strategy (ART-SPARCS) for HIV-positive
        individuals transitioning from correctional to community settings in South Africa. The
        current proposal will allow for a fully powered effectiveness randomized clinical trial
        (RCT).
  
          -  To compare the effectiveness of Full-SPARCS, ART-SPARCS, and Group-SPARCS to care as
             usual and to each other to achieve HIV RNA suppression 6 months following correctional
             facility release
  
          -  To assess determinants of implementation of Full-SPARCS, ART-SPARCS, and Group-SPARCS.
  
          -  To assess the scalability through costing and cost effectiveness analysis of
             Full-SPARCS, ART-SPARCS, and Group-SPARCS.
  Background: The South African government has devoted resources towards HIV care in
        correctional facilities that have resulted in antiretroviral therapy (ART) coverage of >90%
        and viral load (VL) suppression of >80% among incarcerated people living with HIV (PLWH).
        However, despite free post-release care, the investigators previously observed that only an
        estimated 34% were in care three months post-release. The investigators developed, tested,
        and manualized the Structured Peer-delivered ART and Re-entry Community Strategy (SPARCS) to
        overcome post-incarceration barriers specific to PLWH returning to the community.8-10 In the
        investigators randomized controlled pilot of SPARCS, 6-month post-release, continuity of care
        was 61% in the intervention arm compared to 36% in the usual care arm (p=0.001),
        demonstrating effectiveness. Full-SPARCS, has two distinct components spanning six months
        post-release: direct provision of ART (ART-SPARCS) and 12 biweekly peer facilitator-led group
        sessions (Group-SPARCS). ART-SPARCS is designed to overcome clinic-level barriers through
        bimonthly distribution of ART without a group component. Group-SPARCS is designed to increase
        self-efficacy, social support, and life skills through facilitated group discussion and
        curriculum including planning, problem solving, financial literacy, and living with HIV
        without ART distribution. The current usual care is a supply of ART and a referral letter at
        the time of release from incarceration.
  
        Methods: This research study will be conducted in Gauteng Province. Recruitment will occur
        within correctional facilities of the Department of Correctional Services (DCS) - Modderbee,
        Kgosi Mampuru II, and Johannesburg. All study interventions will occur following release in
        either Ekurhuleni District, Tshwane District or Johannesburg District. The study population
        will be comprised of adult (≥18 years old) corrections inmates, either male or female, with
        known HIV infection and are receiving ART within the correctional facility and are expected
        to be released back into the community within 3 months of study enrollment Participants will
        be randomized 1:1:1:1 to either the standard of care, Full-SPARCS, Group-SPARCS, or
        ART-SPARCS using sequential envelopes with study arm determination sealed inside. Study staff
        will contact participants to ascertain care status and update contact information at one
        week, one month, three months, six months, nine months, and twelve months from release.
        Participants assigned to Group-SPARCS or ART-SPARCS will be asked to attend biweekly
        sessions. Group-SPARCS activities will include - structured curriculum, symptom screening,
        and routine laboratory monitoring. ART-SPARCS will include the distribution of pre-packed
        medication and routine laboratory monitoring. Full-SPARCS includes all components of
        Group-SPARCS and ART-SPARCS.
  
        Study sample: A total of 640 participants will be randomized to one of the four arms. Sixty
        of the participants will be selected for participation in qualitative in-depth interviews. An
        additional 25 staff involved in Transition community adherence club (TCAC) referral, ART
        provision, implementation, coordination will be enrolled for qualitative in-depth interviews.
  
        Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research
        and the South African National Strategic Plan on HIV, Tuberculosis (TB), and Sexually
        Transmitted Infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research
        Priority of "retention and engagement in these services, and achievement and maintenance of
        optimal prevention and treatment responses." It also addresses "health disparities" through a
        focus on recently released inmates, a marginalized population. The proposal also fits with
        the South African National Strategic Plan prioritizing inmates as a key population for HIV
        services.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: This is a hybrid type 1 effectiveness-implementation study with a factorial design to compare care as usual, Full-SPARCS, ART-SPARCS, or Group-SPARCS. We will recruit participants from correctional facilities in the Department of Correctional Services (DCS) Gauteng Region, South Africa. Study activities for the intervention arm will be delivered in community venues near to where participants live in Tshwane District, Ekurhuleni District, and City of Johannesburg.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: We will perform individual randomization blocked by the correctional facility. Study staff will open numbered envelopes with the allocation following enrolment. Participants will be randomized 1:1:1:1 to one of the study arms using sequential envelopes with study arm determination sealed inside. Randomization will be stratified by study site and by sex. The randomization lists for each site/sex combination will be generated through randomly permuted blocks of four and eight study assignments with an equal number of group assignments within each block. Study assignments will be masked to staff performing outcome assessments (in-person and telephonic interviews) and the investigators until all outcome data have been collected.
  measure: HIV RNA (viral load) suppression at 6 months
  time frame: 6 months
  description: HIV RNA suppression will be defined as a viral load <1000 copies/mL. Participants without viral load data will be assumed to have a viral load >1000 c/mL.
  measure: HIV RNA (viral load) suppression at 12 months
  time frame: 12 months
  description: HIV RNA suppression will be defined as a viral load <1000 copies/mL. Participants without viral load data will be assumed to have a viral load >1000 c/mL.
  measure: Cost-effectiveness
  time frame: up to 12 months
  description: Cost effectiveness will be measured by combining standardized data collection tools and an analytic framework developed from prior studies to document and classify resources used (e.g. direct human resources, consumables, capital assets) for all intervention-related activities from design, coordination, to direct delivery.
  measure: Percentage of participants receiving ART at 6 months
  time frame: 6 months
  description: Participants receiving ART by 6 months post-release.
  measure: Percentage of participants receiving ART at 12 months
  time frame: 12 months
  description: Participants receiving ART by 12 months post-release.
  arm group label: Care-as-usual (CAU) arm
  arm group type: No Intervention
  description: Per DCS routine, at release, participants will receive a referral letter form the DCS health services and, in most cases, will be provided with a 28-day supply of ART.
  arm group label: Group-SPARCS intervention arm
  arm group type: Experimental
  description: The Group-SPARCS component comprises one individual pre-release session, one individual post-release session, and 12 every-other-week (every two weeks) post-release group sessions extending six months post-release. Each session will be led by two trained individuals: a peer (history of criminal justice involvement and living with HIV) and a social worker.30 Within 14 days of release, participants will have one-on-one contact with a facilitator to update locator information, continue rapport building, review disclosure plans, provide a reminder of SPARCS logistics, and assign or remind the participant to a SPARCS group based on their location of residence and timing of release (depending on whether this occurred pre-release). Each Group-SPARCS meeting lasts approximately 2 hours, and the sessions occur in a private space in a community venue (e.g., community centre or church).
  arm group label: ART-SPARCS intervention arm
  arm group type: Experimental
  description: ART delivery will follow Department of Health (DoH) procedures for differentiated models of care, in particular the Community Adherence Club model. Similar to community adherence clubs, the ART provision in SPARCS will be affiliated with a 'home clinic" that will provide ART supplies for the participants. Routine community adherence club activities include:
  ART will be provided every two months from correctional facility release to 6 months post-release (months 2, 4, and 6). Participants with less than two months of ART at release will receive a top-off to reach two months. ART will be pre-packaged by the DoH "home clinic", collected by the facilitators, and distributed to the participants. At the time of distribution, the facilitators will conduct a standard DoH differentiated care symptom screen. Participants who report specific symptoms will be referred to the "home clinic" for further assessment per routine with Community Adherence Clubs.
  arm group label: Full-SPARCS arm
  arm group type: Experimental
  description: Full-SPARCS combines Group-SPARCS and ART-SPARCS with ART delivery during SPARCS group meetings.
  intervention type: Behavioral
  intervention name: Structured Peer-delivered ART and Reentry Community Strategy
  description: The intervention aims to circumvent clinic barriers by directly providing ART and build behavioral skills (planning, self-efficacy) through peer-facilitator led group sessions to improve care continuity following release from incarceration.
  arm group label: ART-SPARCS intervention arm
  arm group label: Full-SPARCS arm
  arm group label: Group-SPARCS intervention arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Christopher Hoffmann
  role: Principal Investigator
  affiliation: Johns Hopkins School of Medicine
  last name: Christopher Hoffmann
  phone: 4106144257
  email: choffmann@jhmi.edu
  last name: Tonderai Mabuto
  email: tmabuto@auruminstitute.org
  responsible party type: Sponsor