Impact of Rapid ART Initiation on Retention in Care in the Southern US

HIV-1-infection Clinical Trial

— RAPID  

Official title:

Impact of Rapid ART Initiation on Retention in Care in the Southern US

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04266938
• Other study ID #: 20.0017
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: July 2023
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Impact of Rapid ART Initiation on Retention in Care in the Southern US

Specific Goals and Aims:

The major goal for this study is to determine if rapid start of antiretroviral (ART) therapy increases retention in HIV medical care. The investigators hypothesize that there will be an increase in retention in care with rapid start, by removing barriers that would normally delay enrollment in a treatment program and enforce the importance of linkage to care and ART initiation from diagnosis.

In order to test this hypothesis, the investigators have the following specific aims for their proposed study:

1. Study retention in care after rapid ART start in comparison to standard of care.

2. Analyze risk factors for decreased retention in care, with focus on high-risk populations.

3. Analyze potential demographic and geographic determinants of retention in care.

4. Generate retention in care data in a Southern US state.

The investigators hypothesize the introduction of rapid start ART, as well as the introduction of care navigators, will lead to improved clinical outcomes, including retention in care at one year, viral suppression at one year, time to viral suppression, and time to first missed appointment. In the event rapid start ART fails to have a positive impact on clinical outcomes, the results of this study will still positively contribute to the knowledge gap, since there is a scarcity of data in the Southern United States, specifically in high-risk populations, such as racial and ethnic minorities, youth, and patients co-infected with hepatitis C.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 258
• Est. completion date: May 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prospective arms: Human subjects =18 years old, newly diagnosed with HIV who are establishing care at the 550 Clinic.

• Retrospective arm: Human subjects =18 years old, newly diagnosed with HIV who established care at the 550 Clinic and were treated with ART between 2012-2019.

Exclusion Criteria:

• Pregnancy

• Prior HIV diagnosis or exposure to ART

• Medical necessity for therapy with ART agent other than bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), such as drug allergy, drug-drug interactions, creatinine clearance <30.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Behavioral:
• Rapid start of antiretrovirals
Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days
• Retrospective analysis
Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.
• Non- RAPID start
Review of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care.

Locations

Country	Name	City	State
United States	550 Clinic	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in Care	Retention in HIV care at one year after initiation of rapid ART start, defined as 1) keeping at least 3 visits within the first 12 months of care and 2) attending a clinic visit between months 9-15 of the 12-month mark and 3) experiencing no gaps in care greater than 6 months.	12 months