HIV-1-infectionRAPIDNCT04266938
Impact of Rapid ART Initiation on Retention in Care in the Southern US
A study testing Rapid start of antiretrovirals, Retrospective analysis and Non- RAPID start in people with HIV-1-infection, run by University of Louisville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Rapid start of antiretrovirals, Retrospective analysis and Non- RAPID start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Impact of Rapid ART Initiation on Retention in Care in the Southern US
Specific Goals and Aims:
Read more
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.
- Conditions
- HIV-1-infection
- Being tested
- Rapid start of antiretrovirals, Retrospective analysis, Non- RAPID start
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid start of antiretroviralsBehavioural
Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days
Retrospective analysisBehavioural
Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.
Non- RAPID startBehavioural
Review of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Behavioral: Retrospective analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jun 2021
- Primary completion31 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bailey Benidir, PharmD, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266938
- Sponsor's protocol ID
- 20.0017
- Acronym
- RAPID
- Status last verified
- Jul 2025
- First submitted
- 7 Feb 2020
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rapid ART Initiation on Retention in Care in the Southern US
- ClinicalTrials.gov ID
- NCT04266938
- Acronym / sponsor ID
- RAPID / 20.0017
- Conditions
- HIV-1-infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective RAPID | Active comparator | Behavioral: Rapid start of antiretroviralsThe prospective RAPID arm will include all patients who meet inclusion criteria and who start BIC/F/TAF within 7 days of HIV diagnos |
| Prospective Non- RAPID | Active comparator | Behavioral: Non- RAPID startThe 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 |
| Retrospective Non- RAPID | Active comparator | Behavioral: Retrospective analysisThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid start of antiretroviralsUtilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days | Behavioural | Prospective RAPID |
| Retrospective analysisReview historical standard of care relative to time to start antiretrovirals and impact on retention in care. | Behavioural | Retrospective Non- RAPID |
| Non- RAPID startReview of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care. | Behavioural | Prospective Non- RAPID |
Primary outcome
Retention in Care
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid start of antiretrovirals, Retrospective analysis and Non- RAPID start in people with HIV-1-infection, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in Care (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.