Birmingham Access to Care Study

Not Applicable

Completed

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

• Registration Number: NCT02525146
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-08-01
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-17
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-08-07
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Modified ARTAS (Antiretroviral Treatment and Access to Services) 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.

Primary Outcome Measures

Name	Time	Method
Change in HIV-1 Viral Load from Baseline to 12-month Followup	Baseline and 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

Name	Time	Method
Re-Engagement in Care: Post-Enrollment Linkage Visit + Meeting HRSA-HAB Guidelines for Retention in Care	12-month	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.