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

NCT04266938 | Completed

• 1 other identifier: 20.0017
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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. 1.Study retention in care after rapid ART start in comparison to standard of care.
2. 2.Analyze risk factors for decreased retention in care, with focus on high-risk populations.
3. 3.Analyze potential demographic and geographic determinants of retention in care.
4. 4.Generate retention in care data in a Southern US state.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Prospective RAPID

ACTIVE COMPARATOR

The prospective RAPID arm will include all patients who meet inclusion criteria and who start BIC/F/TAF within 7 days of HIV diagnos

Behavioral: Rapid start of antiretrovirals

Prospective Non- RAPID

ACTIVE COMPARATOR

The prospective non-RAPID arm will include all patients identified as having new HIV diagnosis per health department records, but who failed to establish care at the 550 Clinic and begin BIC/F/TAF within one week of diagnosis

Behavioral: Non- RAPID start

Retrospective Non- RAPID

ACTIVE COMPARATOR

The retrospective Non-RAPID arm will include historic controls who enrolled in the treatment program from 2012, when universal ART guidelines were implemented, until prior to the implementation of RAPID start of ART.

Behavioral: Retrospective analysis

Interventions

Rapid start of antiretrovirals BEHAVIORAL

Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days

Prospective RAPID

Retrospective analysis BEHAVIORAL

Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.

Retrospective Non- RAPID

Non- RAPID start BEHAVIORAL

Review of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care.

Prospective Non- RAPID

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

550 Clinic

Louisville, Kentucky, 40202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 12, 2020
• Study Start: June 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: May 30, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)