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OpenTrials
Completed

NCT Number: NCT02525146

Birmingham Access to Care Study

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Care Loss to Followup HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention

Other

Primary outcomes

  1. Change in HIV-1 Viral Load from Baseline to 12-month Followup

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • AIDS United
  • Birmingham AIDS Outreach
  • Johns Hopkins University

Registry information

Acronym: BA2C

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2015
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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