IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas: Addressing Adherence Barriers Through Learning and Evidence-Informed Strategies (IM-CAPABLE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Patient participants determination of acceptability of CAB+RPV LA implementation
研究概览
简要总结
The goal of this implementation science study is to learn about the experience of receiving and providing cabotegravir + rilpivirine long-acting (CAB+RPV LA) injections as treatment for human immunodeficiency virus (HIV) for people who live a significant distance from an HIV provider. The main questions it aims to answer are:
- Is CAB+RPV LA feasible and acceptable to patients and staff?
- What barriers and supports exist and have the most impact on receiving and providing CAB+RPV LA?
- How does CAB+RPV LA affect HIV stigma, treatment satisfaction, medication adherence and viral suppression?
People living with HIV who reside outside of the Omaha, Nebraska metro area and are starting CAB+RPV LA as part of regular medical care for HIV will be invited to participate in this study which involves completing questionnaires and an interview over 15 months. Clinic staff who are involved in providing HIV care and CAB+RPV LA will also provide input through questionnaires and interviews.
详细描述
The UNMC Specialty Care Center (SCC) in Omaha, Nebraska is the only dedicated HIV care facility in the region and serves patients from across the state of Nebraska as well as southwest Iowa. It also provides the sole comprehensive CAB+RPV LA program in the area with highly trained staff, established protocols and workflows for drug acquisition, and more than 75 patients receiving CAB+RPV LA to date.
Although individuals who have transitioned to this new treatment modality report many benefits, including relief at not taking a daily pill (often seen as an unwanted daily reminder of HIV infection), some individuals still face barriers to access this treatment, which must be administered in a medical facility on a monthly or every two month dosing schedule.
For the patients of the UNMC Specialty Care Center (SCC) who live in 79 rural counties in central and eastern Nebraska and 11 counties in Southwest Iowa, some extra barriers might include transportation, bad weather, time away from work to travel, and privacy concerns surrounding receipt of injections. In an effort to improve access, the SCC has partnered with several rural facilities acting as satellite locations for patients to receive CAB+RPV LA injections: 1) the Nebraska Medicine Internal Medicine Clinic in Grand Island, Nebraska (located approximately 150 miles west of Omaha); 2) the Myrtue Medical Center in Harlan, Iowa (approximately 60 miles northeast of Omaha); and 3) the Shenandoah Medical Center in Shenandoah, Iowa (approximately 65 miles southeast of Omaha).
The IM-CAPABLE study aims to evaluate these partnerships and the best ways to provide CAB+RPV LA to patients who live a significant distance from an HIV provider and/or live in rural areas. People living with HIV who reside outside of the Omaha, Nebraska metro area and are starting CAB+RPV LA as part of regular medical care for HIV will be invited to participate in this study which involves completing questionnaires and an interview over 15 months. Clinic staff who are involved in providing HIV care and CAB+RPV LA will also provide input through questionnaires and interviews.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Age ≥ 19 years old (as per Nebraska's adult age definition) with documented HIV infection
- •Receiving care for the management of HIV disease by a provider at the Nebraska Medicine/UNMC Specialty Care Center ( UNMC SCC)
- •Deemed a clinically eligible candidate for CAB+RPV LA per HIV treatment guidelines and through shared medical decision-making by provider and patient
- •Resides outside of the Omaha, Nebraska metropolitan area
排除标准
- •Does not meet the clinical guidelines eligibility criteria for CAB+RPV LA
- •Currently receiving CAB+RPV LA
- •Currently incarcerated
- •Unable to give informed consent for participation
- •Pregnant or planning to become pregnant during the study period
- •Intends to move from their current residence to the Omaha metropolitan area or intend to move out of the Specialty Care Center service area within 12 months after enrollment
- •Staff Inclusion Criteria:
- •Age ≥ 19 years old (as per Nebraska's adult age definition)
- •Staff member of the UNMC SCC, the Nebraska Medicine Grand Island Clinic, the Myrtue Medical Center, or the Shenandoah Medical Center who is providing HIV-related care to patients and has a dedicated role in the IM-CAPABLE study
- •Able to provide written and/or oral feedback as outlined in the implementation method
研究组 & 干预措施
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12) (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: HIV Stigma Scale Questionnaire (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12) (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: Needs and Barriers Assessment (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: Pre-visit Outreach (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: Acceptability of Intervention Measure (AIM) (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: Intervention Appropriateness Measure (IAM) (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: Feasibility of Intervention Measure (FIM) (Behavioral)
Staff
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study.
干预措施: Acceptability of Intervention Measure (AIM) (Behavioral)
Staff
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study.
干预措施: Intervention Appropriateness Measure (IAM) (Behavioral)
Staff
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study.
干预措施: Feasibility of Intervention Measure (FIM) (Behavioral)
Staff
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study.
干预措施: Staff education (Behavioral)
Staff
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study.
干预措施: Staff Month 7 and 15 Survey - Staff Burden and Engagement (Behavioral)
Participants
Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
干预措施: Qualitative interview - patient participants (Behavioral)
Staff
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study.
干预措施: Qualitative interview - staff (Behavioral)
结局指标
主要结局
Patient participants determination of acceptability of CAB+RPV LA implementation
时间窗: 15 months (baseline, month 7 & month 15)
Proportion of patient participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Acceptability of Intervention Measure (AIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
Staff participants determination of the acceptability of CAB+RPV LA implementation
时间窗: 15 months (baseline, month 7 & month 15)
Proportion of staff participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Acceptability of Intervention Measure (AIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
Staff participants determination of the feasibility of CAB+RPV LA implementation
时间窗: 15 months (baseline, month 7 & month 15)
Proportion of staff participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Feasibility of Intervention Measure (FIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
Patient participants determination of feasibility of CAB+RPV LA implementation
时间窗: 15 months (baseline, month 7 & month 15)
Proportion of patient participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Feasibility of Intervention Measure (FIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
次要结局
- CAB+RPV LA effect on patient participants reported treatment satisfaction(15 months (Baseline, Month 7 & Month 15))
- Patient participants' reported change in treatment satisfaction between previous oral treatment and CAB+RPV LA(Month 15)
- Reasons for CAB+RPV LA discontinuation(15 months)
- Site-specific reach of CAB+RPV LA implementation(15 months)
- Site-specific barriers for CAB+RPV LA implementation(16 months)
- Site-specific facilitators for CAB+RPV LA implementation(16 months)
- Virologically suppressed patient participants (plasma HIV RNA <50 copies/mL)(15 months (Baseline, Month 1, Month 3, Month 9 and Month 15))
- Injection Visit Show Rate(15 months)
- CAB+RPV LA effect on patient participants reported stigma(15 months (Baseline, Month 7 & Month 15))
- Site-specific barriers for CAB+RPV LA implementation(16 months)
- Site-specific reach of CAB+RPV LA implementation(15 months)
- Site-specific facilitators for CAB+RPV LA implementation(16 months)
- Injection Visit Show Rate(15 months)
- Virologically suppressed patient participants (plasma HIV RNA <50 copies/mL)(15 months (Baseline, Month 1, Month 3, Month 9 and Month 15))
- Reasons for CAB+RPV LA discontinuation(15 months)
- Patient participants' reported change in treatment satisfaction between previous oral treatment and CAB+RPV LA(Month 15)
- CAB+RPV LA effect on patient participants reported stigma(15 months (Baseline, Month 7 & Month 15))
- CAB+RPV LA effect on patient participants reported treatment satisfaction(15 months (Baseline, Month 7 & Month 15))