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

Study Overview
=================
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: Study retention in care after rapid ART start in comparison to standard of care. Analyze risk factors for decreased retention in care, with focus on high-risk populations. Analyze potential demographic and geographic determinants of retention in care. 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.

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

Conditions
-----------------
HIV-1-infection

Intervention / Treatment
-----------------
* Behavioral: Rapid start of antiretrovirals
* Behavioral: Retrospective analysis
* Behavioral: Non- RAPID start


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prospective RAPID<br>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<br>* Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days<br>|
| Active Comparator: Prospective Non- RAPID<br>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<br>* Review of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care.<br>|
| Active Comparator: Retrospective Non- RAPID<br>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<br>* Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |