Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451341
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-20
Brief Title:
IMplementation of CABRPV LA for People With HIV in Non-Metropolitan Areas
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
IMplementation of CABRPV LA for People With HIV in Non-Metropolitan Areas Addressing Adherence Barriers Through Learning and Evidence-Informed Strategies IM-CAPABLE
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IM-CAPABLE
Brief Summary:
The goal of this implementation science study is to learn about the experience of receiving and providing cabotegravir rilpivirine long-acting CABRPV 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 CABRPV LA feasible and acceptable to patients and staff
What barriers and supports exist and have the most impact on receiving and providing CABRPV LA
How does CABRPV 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 CABRPV LA as part of regular medical care for HIV will be invited to participate in this study by completing questionnaires and an interview over 15 months Clinic staff who are involved in providing HIV care and CABRPV LA will also provide input through questionnaires and an interview
Is CABRPV LA feasible and acceptable to patients and staff
What barriers and supports exist and have the most impact on receiving and providing CABRPV LA
How does CABRPV 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 CABRPV LA as part of regular medical care for HIV will be invited to participate in this study by completing questionnaires and an interview over 15 months Clinic staff who are involved in providing HIV care and CABRPV LA will also provide input through questionnaires and an interview
Detailed 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 CABRPV LA program in the area with highly trained staff established protocols and workflows for drug acquisition and more than 75 patients receiving CABRPV 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 CABRPV LA injections
The IM-CAPABLE study aims to evaluate this partnership and the best ways to provide CABRPV LA to patients who live a significant distance from an HIV provider andor live in rural areas
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 CABRPV LA injections
The IM-CAPABLE study aims to evaluate this partnership and the best ways to provide CABRPV LA to patients who live a significant distance from an HIV provider andor live in rural areas
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None