HIV InfectionsPhase 4ACCELERATENCT06374758
Accelerated ART Initiation for PWHIV Who Are Out of Care
A Phase 4 study testing The Accelerate model of care and bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg in people with HIV Infections and ART, run by University of Missouri-Columbia at 4 sites in United States.
Trial summary
The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, ART, Noncompliance, Patient
- What is being tested?
- The Accelerate model of care and bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Apr 2024to 9 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
PLWH Inclusion criteria: Participants must meet ALL the following inclusion criteria
- 18 years or older at the time of obtaining the informed consent
- Speaks English
- Able to give consent which includes the ability to understand and comply with study requirements and instructions as judged by clinic or study staff
- HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA)
- Out of care, defined as not had a medical visit with an HIV care provider with prescribing privileges for ≥6 months AND not receiving ART for ≥1 month (by self-report)
Site Staff Inclusion criteria:
Participants must meet ALL the following inclusion criteria
- 18 years or older at the time of obtaining the informed consent
- HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites
- Understand the long-term commitment to the study and be willing to participate
- Have adequate resources to complete assessments for the duration of the study
Exclusion criteria PLWH Exclusion criteria: Participants who meet ANY of the following criteria are excluded
- Biktarvy (B/F/TAF) contraindicated or not recommended
- Known history of chronic kidney disease (creatinine clearance <30 mL/min) using Cockcroft-Gault formula AND not on chronic dialysis
- Known history of allergy to B/F/TAF components
- Known history of intermediate-high level resistance to B/F/TAF components (score ≥30 on Stanford HIV Drug Resistance Algorithm) in the available medical record (not having a prior genotype or having M184V/I mutation is NOT an exclusion criterion)
- Concomitant use of contraindicated medications: using drug interaction database either Lexicomp® Drug Interactions (category X Avoid combination) or Liverpool HIV Interactions Checker (category Do not Co-administer) or study drug label (USPI) as reference for list of contraindicated meds.
- Pregnant (by self-report) or planning to become pregnant while enrolled in the study
- HIV-2 infection
- PLWH who are breastfeeding and are not on ART or taking ART without virologic suppression since breastfeeding will not be recommended.
- Active opportunistic infections that would require a delay of ART as judged by the HIV care provider and based on current Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV: such as cryptococcal and Tuberculous meningitis, and CMV retinitis.16
- Not residing in the state of Missouri at the time of the study or planning to relocate during the study period
- Incarcerated at the time of the study enrollment.
Site Staff Exclusion criteria:
- Moving practice location or job relocation within 1 year
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Missouri-Columbia
Columbia, Missouri, 65212
KC Care Health Center
Kansas City, Missouri, 64124
AIDS Project of the Ozarks
Springfield, Missouri, 65804
NOVUS Health
St Louis, Missouri, 63111
About this study
Official title: ACCELERATE a Multisite Prospective Hybrid (Effectiveness-implementation) Type 2 Design, Single-arm, Mixed-methods Study of a Simplified Accelerated ART Initiation Protocol for People With HIV Who Are Out of Care.
The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care.
Read the detailed description
This is a multisite prospective hybrid (effectiveness-implementation) type 2 design, single-arm, mixed-methods study of a simplified accelerated ART initiation protocol for People with HIV who are out of care.
The investigators will assess the effectiveness of achieving HIV viral suppression defined as HIV RNA < 200 copies/mL at week 24 with B/F/TAF (Biktarvy) as a rapid start for PWH who are out of care.
The investigators will also study the acceptability, feasibility, and sustainability of an innovative model of care that combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved ART regimen, a mailed free starter, and re-linkage to care As an implementation science study, the investigators will explore the methods and factors influencing the successful integration of evidence-based practices across diverse settings.
This study will also ask the staff implementing the ACCELERATE approach about its ease of use, feasibility, compliance, and possible obstacles to its application.
- Conditions
- HIV Infections, ART, Noncompliance, Patient
- Being tested
- The Accelerate model of care, bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Accelerate model of careOther
Contact is established by the study team
The patient is provided with a telehealth appointment with an HIV care provider within 24 business hours of contact
At the time of enrollment/initial clinic visit, patients who meet the inclusion and exclusion criteria will be enrolled in the study
The HIV care provider will prescribe B/F/TAF to their pharmacy of choice.
B/F/TAF is dispensed by the designated study pharmacist and mailed to the patient as a free 30-day starter pack to allow time for benefits verification.
A telephone follow-up call by the study team will be conducted within 2 - 4 weeks from the initial clinical visit to assess any adverse events, tolerability, and adherence.
Hand-off to HIV clinic to establish care within 4 weeks. Lab results will be drawn during clinic per HIV care provider which might include CBC, CMP, HIV-1 RNA, CD4, and genotype resistance testing when clinically indicated by the HIV care provider.
bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mgDrug
Same as above, it is the same intervetion
| Study group | Role | What they receive |
|---|---|---|
| Accelerate Model of Care | Experimental | Contact is established by the study team
The patient is provided with a telehealth appointment with an HIV care provider within 24 business hours of contact
At the time of enrollment/initial clinic visit, patients who meet the inclusion and exclusion criteria will be enrolled in the study
The HIV care provider will prescribe B/F/TAF to their pharmacy of choice.
B/F/TAF is dispensed by the designated study pharmacist and mailed to the patient as a free 30-day starter pack to allow time for benefits verification.
A telephone follow-up call by the study team will be conducted within 2 - 4 weeks from the initial clinical visit to assess any adverse events, tolerability, and adherence.
Hand-off to HIV clinic to establish care within 4 weeks. Lab results will be drawn during clinic per HIV care provider which might include CBC, CMP, HIV-1 RNA, CD4, and genotype resistance testing when clinically indicated by the HIV care provider. Receives: Other: The Accelerate model of care; Drug: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
Proportion of participants who have plasma HIV RNA <200 c/mL at Week 24 (observed analysis)
Measured: 24 weeks
To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants.
Quantitative Change in the mean scores of the Acceptability of Intervention Measure (AIM) scores at Weeks 24, and 48 by PLWH Change in the mean scores of the Acceptability of Intervention Measure (AIM)scores from baseline at Week 48 by Staff participants.
Min score: 4 (worst) Max score: 20 (best)
Measured: 1 year
To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants
Quantitative Change in the mean scores of the Intervention Appropriateness Measure (IAM) scores at Weeks 24, and 48 by PLWH Change in the mean scores of the Intervention Appropriateness Measure (IAM) scores from baseline at Week 48 by Staff participants.
Min score: 4 (worst) Max score: 20 (best)
Measured: 1 year
To study the change over time in feasibility of the ACCELERATE model of care in staff participants
Quantitative Change in the mean scores of the Feasibility of Intervention Measure (FIM) scores from baseline at Weeks 24, and 48 by PLWH Change in the mean scores of the Feasibility of Intervention Measure (FIM) scores from baseline at Week 48 by Staff participants.
Min score: 4 (worst) Max score: 20 (best)
Measured: 1 year
To study the change over time in sustainability of the ACCELERATE model of care in staff participants
Quantitative Mean overall score of Clinical Sustainability Assessment Tool (CSAT) and change from baseline at Week 48 by Staff participants.
Min score: 0 (worst) Max score: 147 (best)
Measured: 1 year
Qualitative data
One-on-one Semi-structured interviews with PLWH and Staff Participants at end of study.
Measured: 1 year
Secondary outcomes (10)
To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care.
The proportion of participants who
- Have HIV RNA <50 c/mL at Week 24 and 48 (observed analysis)
- Have HIV RNA <50 c/mL at Week 24 and 48 using Intent-to-treat (ITT) analysis, including all participants who have received at least one dose of B/F/TAF.
Measured: 1 year
To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care
Change from baseline in overall Consumer Assessment of Healthcare Providers and Systems-Clinician and Group (CAHPS®-CG)19 at Weeks 24, and 48.
The CG-CAHPS Adult Visit Survey contains 42 items, of which 13 are used to create three composites which assess Access to Care (five items), Doctor Communication (six items), and Courteous/Helpful Staff (two items). The survey also includes two questions that ask respondents (1) to rate their doctor, and (2) report if they would recommend the doctor's office to family and friends. In addition, respondents are asked about their overall health, age, gender, and education.
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3480671/
Measured: 1 year
To assess change in health-related quality of life (HRQoL)
Change from baseline in Physical Component Summary (PCS) score and \& Mental Component Summary (MCS) of the Short Form (SF-36®)20 at Weeks 24, and 48.
Min score: 0 (worst) Max score: 3600 (best) source: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html
Measured: 1 year
To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF
Change from week 4 in the overall score of the treatment Satisfaction Questionnaire21 at Weeks 24, and 48. To account for a potential ceiling effect that may occur due to the baseline, the appropriate version of the HIV treatment satisfaction questionnaire (HIVTSQ) (status or change) will be used.
Min score: 0 (worst) Max score: 60 (best)
Measured: 1 year
To measure Retention in Care
- The proportion of participants who completed their Week 24 and Week 48 visit
- The proportion of participants who met the definition of the Health Resources \& Services Administration (HRSA) HIV/AIDS Bureau Annual RIC22 at Week 48 (had at least 2 encounters within the 12-month measurement year).
Measured: 1 year
To assess the adherence to the study treatment
Using the 3-item self-reported adherence measure Weeks 4, 24, and 48.
The 3 items are:
- Number of days of missed treatment
- In the last 30 days, how good a job did you do at taking your HIV medicines in the way that you were supposed to?
- In the last 30 days how often did you take your HIV medicines in the way that you were supposed to?
For analyses item responses for the three adherence items will be linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. Therefore:
Min score: 0 (worst) Max score: 300 (best) source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5071118/
Measured: 1 year
To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.
Incidence of treatment-emergent genotypic resistance to B/F/TAF or any other ART, in participants meeting confirmed virologic failure (inability to achieve HIV RNA <200 c/mL at week 24 or to maintain HIV RNA <200 c/mL after virologic suppression).
Measured: 1 year
To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.
Change from baseline/week 4 in CD4 cell counts at Weeks 24 and 48.
Measured: 1 year
To assess staff impact of ACCELERATE model of care on staff satisfaction
Using the staff questionnaire at baseline and week 48 min score: 5 (worst) max score: 25 (best)
Measured: 1 year
To assess staff impact of ACCELERATE model of care on staff burnout
Using the staff questionnaire at baseline and week 48 Min score: 10 (best) Max score: 70 (worst)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start29 Apr 2024
- Primary completion9 Aug 2026 (estimated)
- Study completion9 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Dima Dandachi, University of Missouri-Columbia
- Investigators
- Dima Dandachi, MD, MPH, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374758
- Sponsor's protocol ID
- MU-2096449
- Acronym
- ACCELERATE
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Unauthorized disclosure of personal information could lead to damage to the subjects' reputation. Subjects may experience embarrassment and social stigmatization if private details about their health conditions, behaviors, or personal history become known to others in their community or social circles. The loss of privacy may lead to psychological distress, anxiety, or emotional harm, can expose individuals to discrimination or prejudice. Fear of privacy breaches may result in reduced willingness of individuals to participate in future research studies, impacting the scientific community's ability to conduct meaningful research. To mitigate these risks, we incorporated robust privacy protection measures, including secure data storage and de-identification of data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCELERATE a Multisite Prospective Hybrid (Effectiveness-implementation) Type 2 Design, Single-arm, Mixed-methods Study of a Simplified Accelerated ART Initiation Protocol for People With HIV Who Are Out of Care.
- ClinicalTrials.gov ID
- NCT06374758
- Acronym / sponsor ID
- ACCELERATE / MU-2096449
- Conditions
- HIV Infections, ART, Noncompliance, Patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 9 Aug 2026 (estimated)
- Study completion
- 9 Aug 2027 (estimated)
- First posted
- 19 Apr 2024 (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.
The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care.
Detailed description
This is a multisite prospective hybrid (effectiveness-implementation) type 2 design, single-arm, mixed-methods study of a simplified accelerated ART initiation protocol for People with HIV who are out of care.
The investigators will assess the effectiveness of achieving HIV viral suppression defined as HIV RNA < 200 copies/mL at week 24 with B/F/TAF (Biktarvy) as a rapid start for PWH who are out of care.
The investigators will also study the acceptability, feasibility, and sustainability of an innovative model of care that combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved ART regimen, a mailed free starter, and re-linkage to care As an implementation science study, the investigators will explore the methods and factors influencing the successful integration of evidence-based practices across diverse settings.
This study will also ask the staff implementing the ACCELERATE approach about its ease of use, feasibility, compliance, and possible obstacles to its application.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerate Model of Care | Experimental | Other: The Accelerate model of care, Drug: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mgContact is established by the study team The patient is provided with a telehealth appointment with an HIV care provider within 24 business hours of contact At the time of enrollment/initial clinic visit, patients who meet the inclusion and exclusion criteria will be enrolled in the study The HIV care provider will prescribe B/F/TAF to their pharmacy of choice. B/F/TAF is dispensed by the designated study pharmacist and mailed to the patient as a free 30-day starter pack to allow time for benefits verification. A telephone follow-up call by the study team will be conducted within 2 - 4 weeks from the initial clinical visit to assess any adverse events, tolerability, and adherence. Hand-off to HIV clinic to establish care within 4 weeks. Lab results will be drawn during clinic per HIV care provider which might include CBC, CMP, HIV-1 RNA, CD4, and genotype resistance testing when clinically indicated by the HIV care provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| The Accelerate model of careContact is established by the study team The patient is provided with a telehealth appointment with an HIV care provider within 24 business hours of contact At the time of enrollment/initial clinic visit, patients who meet the inclusion and exclusion criteria will be enrolled in the study The HIV care provider will prescribe B/F/TAF to their pharmacy of choice. B/F/TAF is dispensed by the designated study pharmacist and mailed to the patient as a free 30-day starter pack to allow time for benefits verification. A telephone follow-up call by the study team will be conducted within 2 - 4 weeks from the initial clinical visit to assess any adverse events, tolerability, and adherence. Hand-off to HIV clinic to establish care within 4 weeks. Lab results will be drawn during clinic per HIV care provider which might include CBC, CMP, HIV-1 RNA, CD4, and genotype resistance testing when clinically indicated by the HIV care provider. | Other | Accelerate Model of Care |
| bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mgSame as above, it is the same intervetion | Drug | Accelerate Model of Care |
Primary outcome
The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
Time frame: 24 weeks
Proportion of participants who have plasma HIV RNA <200 c/mL at Week 24 (observed analysis)
To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants.
Time frame: 1 year
Quantitative Change in the mean scores of the Acceptability of Intervention Measure (AIM) scores at Weeks 24, and 48 by PLWH Change in the mean scores of the Acceptability of Intervention Measure (AIM)scores from baseline at Week 48 by Staff participants. Min score: 4 (worst) Max score: 20 (best)
To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants
Time frame: 1 year
Quantitative Change in the mean scores of the Intervention Appropriateness Measure (IAM) scores at Weeks 24, and 48 by PLWH Change in the mean scores of the Intervention Appropriateness Measure (IAM) scores from baseline at Week 48 by Staff participants. Min score: 4 (worst) Max score: 20 (best)
To study the change over time in feasibility of the ACCELERATE model of care in staff participants
Time frame: 1 year
Quantitative Change in the mean scores of the Feasibility of Intervention Measure (FIM) scores from baseline at Weeks 24, and 48 by PLWH Change in the mean scores of the Feasibility of Intervention Measure (FIM) scores from baseline at Week 48 by Staff participants. Min score: 4 (worst) Max score: 20 (best)
To study the change over time in sustainability of the ACCELERATE model of care in staff participants
Time frame: 1 year
Quantitative Mean overall score of Clinical Sustainability Assessment Tool (CSAT) and change from baseline at Week 48 by Staff participants. Min score: 0 (worst) Max score: 147 (best)
Qualitative data
Time frame: 1 year
One-on-one Semi-structured interviews with PLWH and Staff Participants at end of study.
10 secondary outcomes
To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care.
Time frame: 1 year
To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care
Time frame: 1 year
To assess change in health-related quality of life (HRQoL)
Time frame: 1 year
To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF
Time frame: 1 year
To measure Retention in Care
Time frame: 1 year
To assess the adherence to the study treatment
Time frame: 1 year
To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.
Time frame: 1 year
To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.
Time frame: 1 year
To assess staff impact of ACCELERATE model of care on staff satisfaction
Time frame: 1 year
To assess staff impact of ACCELERATE model of care on staff burnout
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Unauthorized disclosure of personal information could lead to damage to the subjects' reputation. Subjects may experience embarrassment and social stigmatization if private details about their health conditions, behaviors, or personal history become known to others in their community or social circles. The loss of privacy may lead to psychological distress, anxiety, or emotional harm, can expose individuals to discrimination or prejudice. Fear of privacy breaches may result in reduced willingness of individuals to participate in future research studies, impacting the scientific community's ability to conduct meaningful research. To mitigate these risks, we incorporated robust privacy protection measures, including secure data storage and de-identification of data.
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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.
Dima Dandachi, MD, MPH principal investigator
University of Missouri-Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The Accelerate model of care and bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg in people with HIV Infections and ART, run by University of Missouri-Columbia at 4 sites 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?
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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. (time frame: 24 weeks). The study lists 6 primary outcomes in all. 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 5 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.