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Birmingham Access to Care Study (BA2C)

Primary Purpose

HIV Infection, HIV Care Loss to Followup

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, Reengagement in HIV Care, ARTAS

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV patient with at least one primary care appointment since 1/1/10 but currently lost to follow-up defined as 1) currently out of care for greater than 7 months or 2) does NOT have two or more completed clinic visits separated by three or more months in time during a 12-month observation period (HRSA-HAB measure of retention in care) or 3) has 2 or more "no shows" - scheduled visits for which the patient has not arrived or canceled - in the past 12 months.
  • 19 years or older
  • Be able and willing to provide informed consent
  • Be willing to provide locator information
  • Be willing to sign a HIPAA authorization form/medical record release form to facilitate medical record abstraction
  • Report living in the vicinity
  • Be able to communicate in English.

Exclusion Criteria:

  • Not meeting one of the above inclusion criteria
  • Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
  • Incarcerated at the time of potential enrollment
  • Are terminated via site PI decision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Usual Care

    Arm Description

    Patients randomized to the intervention arm receive intensive social work case management based on the ARTAS (Antiretroviral Treatment and Access to Services) model. Patients may participate in 6-12 visits over a six-month period aimed at addressing barriers to re-engagement in HIV care. Participants complete a battery of research questions at Baseline, 6-months, and 12-months and HIV-1 viral load and CD4 count labwork at Baseline and at 12-months post enrollment.

    Patients randomized to the usual care arm are provide contact information for an HIV primary care clinic and for local AIDS service organizations. Patients are then encouraged to contact these organizations to re-establish care. Participants complete a battery of research questions at Baseline, 6-months, and 12-months and HIV-1 viral load and CD4 count labwork at Baseline and at 12-months post enrollment. Patients in the usual care arm are offered the intensive casework intervention after their 12-month followup is complete.

    Outcomes

    Primary Outcome Measures

    Change in HIV-1 Viral Load from Baseline to 12-month Followup
    HIV-1 viral load is obtained via study-specific lab work done at Baseline and at the 12-month followup session.

    Secondary Outcome Measures

    Re-Engagement in Care: Post-Enrollment Linkage Visit + Meeting HRSA-HAB Guidelines for Retention in Care
    Using HIV primary care clinic attendance records, participants are assessed as to 1) whether or not an HIV Primary Care visit was completed post study enrollment and 2) following that visit, whether the participant made and kept appointments as necessary to meet HRSA-HAB guidelines constituting retention in HIV care. BOTH conditions must be present in order for participant to be considered "re-engaged" in care.

    Full Information

    First Posted
    August 1, 2015
    Last Updated
    August 7, 2016
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    Birmingham AIDS Outreach, Johns Hopkins University, AIDS United
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02525146
    Brief Title
    Birmingham Access to Care Study
    Acronym
    BA2C
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    Birmingham AIDS Outreach, Johns Hopkins University, AIDS United

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether a modified form of the ARTAS (Antiretroviral Treatment and Access to Services) intervention, adapted for HIV patients who have fallen out of care, can be successful in re-engaging patients in care and reducing HIV-1 viral load.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection, HIV Care Loss to Followup
    Keywords
    HIV, Reengagement in HIV Care, ARTAS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    170 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Patients randomized to the intervention arm receive intensive social work case management based on the ARTAS (Antiretroviral Treatment and Access to Services) model. Patients may participate in 6-12 visits over a six-month period aimed at addressing barriers to re-engagement in HIV care. Participants complete a battery of research questions at Baseline, 6-months, and 12-months and HIV-1 viral load and CD4 count labwork at Baseline and at 12-months post enrollment.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to the usual care arm are provide contact information for an HIV primary care clinic and for local AIDS service organizations. Patients are then encouraged to contact these organizations to re-establish care. Participants complete a battery of research questions at Baseline, 6-months, and 12-months and HIV-1 viral load and CD4 count labwork at Baseline and at 12-months post enrollment. Patients in the usual care arm are offered the intensive casework intervention after their 12-month followup is complete.
    Intervention Type
    Other
    Intervention Name(s)
    Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention
    Primary Outcome Measure Information:
    Title
    Change in HIV-1 Viral Load from Baseline to 12-month Followup
    Description
    HIV-1 viral load is obtained via study-specific lab work done at Baseline and at the 12-month followup session.
    Time Frame
    Baseline and 12-month Followup
    Secondary Outcome Measure Information:
    Title
    Re-Engagement in Care: Post-Enrollment Linkage Visit + Meeting HRSA-HAB Guidelines for Retention in Care
    Description
    Using HIV primary care clinic attendance records, participants are assessed as to 1) whether or not an HIV Primary Care visit was completed post study enrollment and 2) following that visit, whether the participant made and kept appointments as necessary to meet HRSA-HAB guidelines constituting retention in HIV care. BOTH conditions must be present in order for participant to be considered "re-engaged" in care.
    Time Frame
    12-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV patient with at least one primary care appointment since 1/1/10 but currently lost to follow-up defined as 1) currently out of care for greater than 7 months or 2) does NOT have two or more completed clinic visits separated by three or more months in time during a 12-month observation period (HRSA-HAB measure of retention in care) or 3) has 2 or more "no shows" - scheduled visits for which the patient has not arrived or canceled - in the past 12 months. 19 years or older Be able and willing to provide informed consent Be willing to provide locator information Be willing to sign a HIPAA authorization form/medical record release form to facilitate medical record abstraction Report living in the vicinity Be able to communicate in English. Exclusion Criteria: Not meeting one of the above inclusion criteria Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent Incarcerated at the time of potential enrollment Are terminated via site PI decision
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James L Raper, PhD, CRNP, JD
    Organizational Affiliation
    University of Alabama at Birmingham, 1917 HIV Clinic
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michael J Mugavero, MD, MHSc
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    David S Batey, PhD, MSW, LCSW
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Birmingham Access to Care Study

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