Birmingham Access to Care Study

HIV Infection Clinical Trial

— BA2C  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525146
• Other study ID #: F130522004
• Status: Completed
• Phase: N/A
• First received: August 1, 2015
• Last updated: August 7, 2016
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Care Loss to Followup
• HIV Infection
• HIV Infections

Intervention

Other:
• Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	AIDS United, Birmingham AIDS Outreach, Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No