IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
NCT ID: NCT06451341
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
55 participants
OBSERVATIONAL
2024-07-01
2027-04-30
Brief Summary
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* 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.
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Detailed Description
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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 the Nebraska Medicine Internal Medicine Clinic in Grand Island, Nebraska (a rural facility located approximately 150 miles from Omaha) to provide a satellite location for patients to receive CAB+RPV LA injections.
The IM-CAPABLE study aims to evaluate this partnership 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 an interview.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Acceptability of Intervention Measure (AIM)
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.
Intervention Appropriateness Measure (IAM)
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.
Feasibility of Intervention Measure (FIM)
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.
HIV Stigma Scale Questionnaire
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.
HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12)
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.
HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12)
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.
Needs and Barriers Assessment
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.
Pre-visit Outreach
Patient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment.
Qualitative interview
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
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.
Acceptability of Intervention Measure (AIM)
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.
Intervention Appropriateness Measure (IAM)
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.
Feasibility of Intervention Measure (FIM)
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.
Qualitative interview
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 education
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.
Staff Month 7 and 15 Survey - Staff Burden and Engagement
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.
Interventions
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Acceptability of Intervention Measure (AIM)
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.
Intervention Appropriateness Measure (IAM)
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.
Feasibility of Intervention Measure (FIM)
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.
HIV Stigma Scale Questionnaire
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.
HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12)
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.
HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12)
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.
Needs and Barriers Assessment
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.
Pre-visit Outreach
Patient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment.
Qualitative interview
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 education
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.
Staff Month 7 and 15 Survey - Staff Burden and Engagement
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Nada Fadul, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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Nebraska Medicine Grand Island Clinic
Grand Island, Nebraska, United States
University of Nebraska Specialty Care Center
Omaha, Nebraska, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0277-24-EP
Identifier Type: -
Identifier Source: org_study_id
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