Accelerated ART Initiation for PWHIV Who Are Out of Care
- Conditions
- HIV InfectionsARTNoncompliance, Patient
- Interventions
- Other: The Accelerate model of careDrug: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg
- Registration Number
- NCT06374758
- Lead Sponsor
- University of Missouri-Columbia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Accelerate Model of Care bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg 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. Accelerate Model of Care The 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.
- Primary Outcome Measures
Name Time Method The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. 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 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 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. 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 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 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 Outcome Measures
Name Time Method To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care. 1 year 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.To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care 1 year 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/To assess staff impact of ACCELERATE model of care on staff satisfaction 1 year Using the staff questionnaire at baseline and week 48 min score: 5 (worst) max score: 25 (best)
To assess staff impact of ACCELERATE model of care on staff burnout 1 year Using the staff questionnaire at baseline and week 48 Min score: 10 (best) Max score: 70 (worst)
To assess change in health-related quality of life (HRQoL) 1 year 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.htmlTo measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF 1 year 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)To measure Retention in Care 1 year * 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).To assess the adherence to the study treatment 1 year Using the 3-item self-reported adherence measure Weeks 4, 24, and 48.
The 3 items are:
1. Number of days of missed treatment
2. 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?
3. 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/To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. 1 year 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).
To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. 1 year Change from baseline/week 4 in CD4 cell counts at Weeks 24 and 48.
Trial Locations
- Locations (4)
AIDS Project of the Ozarks
🇺🇸Springfield, Missouri, United States
University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States
KC Care Health Center
🇺🇸Kansas City, Missouri, United States
NOVUS Health
🇺🇸Saint Louis, Missouri, United States