Birmingham Access to Care Study

NCT ID: NCT02525146

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

HIV Infection; HIV Care Loss to Followup

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention

Intervention Type: OTHER

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.

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Birmingham AIDS Outreach

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

AIDS United

UNKNOWN

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James L Raper, PhD, CRNP, JD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham, 1917 HIV Clinic

Michael J Mugavero, MD, MHSc

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

David S Batey, PhD, MSW, LCSW

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Other Identifiers

F130522004

Identifier Type: -

Identifier Source: org_study_id