Birmingham Access to Care Study (BA2C)

The University of Alabama at Birmingham

Status: Completed

Conditions: HIV Infection; HIV Care Loss to Followup

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02525146

F130522004

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

170 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

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

Usual Care

No Intervention group

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.