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.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •1) Moving practice location or job relocation within 1 year
研究组 & 干预措施
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.
干预措施: The Accelerate model of care (Other)
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.
干预措施: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg (Drug)
结局指标
主要结局
The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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 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)
- To assess change in health-related quality of life (HRQoL)(1 year)
研究者
Dima Dandachi
Assistant Professor, Medical Director of HIV treatment and prevention, Columbia/Boone County Health and Human Services
University of Missouri-Columbia