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

University of Louisville (UOFL)

Status: Completed

Conditions: HIV-1-infection

Treatments: Behavioral: Non- RAPID start; Behavioral: Rapid start of antiretrovirals; Behavioral: Retrospective analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04266938

20.0017

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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258 participants in 3 patient groups

Prospective RAPID

Active Comparator group

Description:

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

Treatment:

Behavioral: Rapid start of antiretrovirals

Prospective Non- RAPID

Active Comparator group

Description:

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

Treatment:

Behavioral: Non- RAPID start

Retrospective Non- RAPID

Active Comparator group

Description:

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.

Treatment:

Behavioral: Retrospective analysis