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.
Overview
- Phase
- Phase 4
- Intervention
- The Accelerate model of care
- Conditions
- HIV Infections
- Sponsor
- University of Missouri-Columbia
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Dima Dandachi
Assistant Professor, Medical Director of HIV treatment and prevention, Columbia/Boone County Health and Human Services
University of Missouri-Columbia
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Accelerate Model of Care
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.
Intervention: The Accelerate model of care
Accelerate Model of Care
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.
Intervention: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg
Outcomes
Primary Outcomes
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 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)
Qualitative data
Time Frame: 1 year
One-on-one Semi-structured interviews with PLWH and Staff Participants at end of study.
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 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)
Secondary Outcomes
- 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 staff impact of ACCELERATE model of care on staff satisfaction(1 year)
- To assess staff impact of ACCELERATE model of care on staff burnout(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)
- To assess the adherence to the study treatment(1 year)
- To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.(1 year)
- To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.(1 year)