IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
IM-CAPABLE
1 other identifier
observational
55
1 country
2
Brief Summary
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 an interview.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2024
Typical duration for all trials
2 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
May 20, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 15, 2026
October 1, 2025
2.8 years
May 20, 2024
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Patient participants determination of acceptability of CAB+RPV LA implementation
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.
15 months (baseline, month 7 & month 15)
Patient participants determination of feasibility of CAB+RPV LA implementation
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.
15 months (baseline, month 7 & month 15)
Staff participants determination of the acceptability of CAB+RPV LA implementation
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.
15 months (baseline, month 7 & month 15)
Staff participants determination of the feasibility of CAB+RPV LA implementation
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.
15 months (baseline, month 7 & month 15)
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Other Outcomes (1)
Describe patient reported barriers to receiving CAB+RPV LA
15 months (Baseline, Month 7 and Month 15)
Study Arms (2)
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.
Staff
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center or the Nebraska Medicine Grand Island clinic who provide HIV-related care and are involved in this study.
Interventions
The HIV Treatment Satisfaction Questionnaire was developed to evaluate treatments for HIV and patient satisfaction. The original 10 item HIVTSQ, which underwent two stages of psychometric validation, has been adapted to include questions regarding injectable treatment for HIV. Two versions of the HIVTSQ are being used. The status version (HIVTSQs12) will assess change in treatment satisfaction over time, and the change version (HIVTSQc12) will assess the change in treatment satisfaction between a patient participant's previous and current treatment. The status version will be administered at Baseline, Month 7 and Month 15.
The Needs and Barriers Assessment is a questionnaire designed to assess patient participant barriers and social determinants of health, emotional challenges related to antiretroviral therapy, and the impact of switching to CAB+RPV LA treatment. This will be administered at Baseline, Month 7 and Month 15.
Patient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment.
Qualitative interviews will be conducted within thirty days after study completion at Month 15 to further evaluate the participant's experience with the implementation of CAB+RPV LA treatment.
Staff participants will participate in Extension for Community Healthcare Outcomes (Project ECHO) educational sessions with topics such as fundamentals of HIV treatment and care, HIV outcomes, delivery of antiretroviral therapies (ART) including long-acting ART, cultural sensitivity, and social determinants of health in rural areas.
The Staff Burden and Engagement survey is a questionnaire designed to assess staff participant perceptions of engagement, burden, facilitators, barriers, communication, resources and challenges related to the implementation of long-acting injectable therapy at their clinic. This will be administered at Month 7 and Month 15.
The Intervention Appropriateness Measure (IAM) questionnaire will be administered at Baseline to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a "leading indicator" of implementation success. The IAM will measure the extent to which participants believe CAB+RPV LA implementation is appropriate.
The Feasibility of Intervention Measure (FIM) questionnaire will be administered at Baseline, Month 7 and Month 15 to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a "leading indicator" of implementation success. The FIM will measure the extent to which participants believe CAB+RPV LA implementation is feasible.
The Acceptability of Intervention Measure (AIM) questionnaire will be administered at Baseline, Month 7 and Month 15 to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a "leading indicator" of implementation success. The AIM will measure the extent to which participants believe CAB+RPV LA implementation is acceptable.
The HIV Stigma Scale Questionnaire used in this study is a shortened version of the validated 40-item HIV stigma scale. This 12-item questionnaire measures the same four stigma subscales measured in the original version, for a streamlined approach to collecting this data on personalized stigma, disclosure concerns, concerns with public attitudes and negative self-image. This will be administered at Baseline, Month 7 and Month 15.
The HIV Treatment Satisfaction Questionnaire was developed to evaluate treatments for HIV and patient satisfaction. The original 10 item HIVTSQ, which underwent two stages of psychometric validation, has been adapted to include questions regarding injectable treatment for HIV. Two versions of the HIVTSQ are being used. The status version (HIVTSQs12) will assess change in treatment satisfaction over time, and the change version (HIVTSQc12) will assess the change in treatment satisfaction between a patient participant's previous and current treatment. The change version will be administered at Month 15.
Eligibility Criteria
HIV+ patients at the University of Nebraska Medical Center Specialty Care Clinic (UNMC SCC) who reside outside the Omaha metropolitan area and/or in rural areas who meet eligibility criteria. They are identified through the Human Immunodeficiency Virus (HIV) registry. Clinical staff involved in HIV care at either UNMC SCC or at Nebraska Medicine Grand Island Clinic who meet eligibility criteria. They will be contacted by email or phone for possible participation.
You may qualify if:
- 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
You may not qualify if:
- 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
- Age ≥ 19 years old (as per Nebraska's adult age definition)
- Staff member of the UNMC SCC or the Grand Island clinic 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraskalead
- ViiV Healthcarecollaborator
Study Sites (2)
Nebraska Medicine Grand Island Clinic
Grand Island, Nebraska, 68803, United States
University of Nebraska Specialty Care Center
Omaha, Nebraska, 68106, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nada Fadul, MD
University of Nebraska
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2024
First Posted
June 11, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 15, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share