Birmingham Access to Care Study

NCT02525146 | Completed

• 1 other identifier: F130522004
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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

Keywords

HIV; Reengagement in HIV Care; ARTAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Re-Engagement in Care: Post-Enrollment Linkage Visit + Meeting HRSA-HAB Guidelines for Retention in Care

  12-month

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention OTHER

Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Birmingham AIDS Outreach: collaborator
• Johns Hopkins University: collaborator
• AIDS United: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Methods

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• James L Raper, PhD, CRNP, JD

  University of Alabama at Birmingham, 1917 HIV Clinic

  PRINCIPAL INVESTIGATOR

• Michael J Mugavero, MD, MHSc

  University of Alabama at Birmingham

  STUDY DIRECTOR

• David S Batey, PhD, MSW, LCSW

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2015
• First Posted: August 17, 2015
• Study Start: September 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-07