IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas (IM-CAPABLE)
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Details and patient eligibility
About
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.
Full description
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 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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
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
Patient Exclusion Criteria:
- 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 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
Trial design
55 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Jennifer O'Neill, BSN, RN; Maureen Kubat, BSN, RN
Data sourced from clinicaltrials.gov
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