IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas (NCT06451341) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
United States55 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient participants determination of acceptability of CAB+RPV LA implementation