Birmingham Access to Care Study (BA2C)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; HIV Care Loss to Followup
• Intervention / Treatment: Other: Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 12-month Followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-month

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Johns Hopkins University; Birmingham AIDS Outreach; AIDS United
• Investigators: Principal Investigator: James L Raper, PhD, CRNP, JD, University of Alabama at Birmingham, 1917 HIV Clinic; Study Director: Michael J Mugavero, MD, MHSc, University of Alabama at Birmingham; Study Director: David S Batey, PhD, MSW, LCSW, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 1, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: HIV; Reengagement in HIV Care; ARTAS
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents
• Other Study ID Numbers: F130522004