Accelerated ART Initiation for PWHIV Who Are Out of Care
ACCELERATE
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.
1 other identifier
interventional
120
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Apr 2024
Typical duration for phase_4 hiv-infections
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedStudy Start
First participant enrolled
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedApril 20, 2025
April 1, 2025
2 years
March 27, 2024
April 18, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
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)
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)
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)
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)
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)
1 year
Qualitative data
One-on-one Semi-structured interviews with PLWH and Staff Participants at end of study.
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.
1 year
To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care
1 year
To assess change in health-related quality of life (HRQoL)
1 year
To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF
1 year
To measure Retention in Care
1 year
- +5 more secondary outcomes
Study Arms (1)
Accelerate Model of Care
EXPERIMENTALContact 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.
Interventions
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.
Same as above, it is the same intervetion
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
- 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.
- \) Moving practice location or job relocation within 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Missouri-Columbialead
- Gilead Sciencescollaborator
Study Sites (4)
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
KC Care Health Center
Kansas City, Missouri, 64124, United States
AIDS Project of the Ozarks
Springfield, Missouri, 65804, United States
NOVUS Health
St Louis, Missouri, 63111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dima Dandachi, MD, MPH
University of Missouri-Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Medical Director of HIV treatment and prevention, Columbia/Boone County Health and Human Services
Study Record Dates
First Submitted
March 27, 2024
First Posted
April 19, 2024
Study Start
April 29, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
April 20, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
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.