Impact of Rapid ART Initiation on Retention in Care in the Southern US
NCT ID: NCT04266938
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
258 participants
INTERVENTIONAL
2021-06-01
2024-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)
NCT06541028
Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
NCT03897725
Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South
NCT06487390
Increasing PrEP Among African Americans in Louisville KY
NCT03559595
Supportive Therapy for Adherence to ART(STAART)
NCT00212940
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prospective RAPID
The prospective RAPID arm will include all patients who meet inclusion criteria and who start BIC/F/TAF within 7 days of HIV diagnos
Rapid start of antiretrovirals
Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days
Prospective Non- RAPID
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
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.
Retrospective Non- RAPID
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.
Retrospective analysis
Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Louisville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bailey Benidir, PharmD
Clinical Pharmacist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
550 Clinic
Louisville, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20.0017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.