HIV InfectionBA2CNCT02525146
Birmingham Access to Care Study
A study testing Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention in people with HIV Infection and HIV Care Loss to Followup, run by University of Alabama at Birmingham.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV Infection, HIV Care Loss to Followup
- What is being tested?
- Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this 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.
- Conditions
- HIV Infection, HIV Care Loss to Followup
- Being tested
- Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention
- Keywords
- HIV, Reengagement in HIV Care, ARTAS
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ARTAS (Antiretroviral Treatment and Access to Services) interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12-month Followup
Secondary outcomes (1)
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.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham AIDS Outreach, Johns Hopkins University, AIDS United
- Responsible party
- Sponsor
- Investigators
- James L Raper, PhD, CRNP, JD, Principal investigator, University of Alabama at Birmingham, 1917 HIV ClinicMichael J Mugavero, MD, MHSc, Study director, University of Alabama at BirminghamDavid S Batey, PhD, MSW, LCSW, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525146
- Sponsor's protocol ID
- F130522004
- Acronym
- BA2C
- Status last verified
- Jul 2016
- First submitted
- 1 Aug 2015
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birmingham Access to Care Study
- ClinicalTrials.gov ID
- NCT02525146
- Acronym / sponsor ID
- BA2C / F130522004
- Conditions
- HIV Infection, HIV Care Loss to Followup
- Keywords
- HIV, Reengagement in HIV Care, ARTAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Birmingham AIDS Outreach, Johns Hopkins University, AIDS United
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Modified ARTAS (Antiretroviral Treatment and Access to Services) interventionPatients 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. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention | Other | Intervention |
Primary outcome
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.
1 secondary outcome
Re-Engagement in Care: Post-Enrollment Linkage Visit + Meeting HRSA-HAB Guidelines for Retention in Care
Time frame: 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L Raper, PhD, CRNP, JD principal investigator
University of Alabama at Birmingham, 1917 HIV Clinic
Michael J Mugavero, MD, MHSc study director
University of Alabama at Birmingham
David S Batey, PhD, MSW, LCSW study director
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention in people with HIV Infection and HIV Care Loss to Followup, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV-1 Viral Load from Baseline to 12-month Followup (time frame: Baseline and 12-month Followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.