Clinical trial NCT06451341: IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
Official title: IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas: Addressing Adherence Barriers Through Learning and Evidence-Informed Strategies (IM-CAPABLE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Keywords: CAB
RPV
Cabotegravir
Rilpivirine
Long acting injections
Rural
Antiretroviral therapy
HIV-1
Implementation science
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2024-06-11
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Patient participants determination of acceptability of CAB+RPV LA implementation
timeFrame: 15 months (baseline, month 7 & month 15)
measure: Patient participants determination of feasibility of CAB+RPV LA implementation
timeFrame: 15 months (baseline, month 7 & month 15)
measure: Staff participants determination of the acceptability of CAB+RPV LA implementation
timeFrame: 15 months (baseline, month 7 & month 15)
measure: Staff participants determination of the feasibility of CAB+RPV LA implementation
timeFrame: 15 months (baseline, month 7 & month 15)
Secondary outcomes:
measure: Site-specific reach of CAB+RPV LA implementation
timeFrame: 15 months
measure: Site-specific barriers for CAB+RPV LA implementation
timeFrame: 16 months
measure: Site-specific facilitators for CAB+RPV LA implementation
timeFrame: 16 months
measure: Virologically suppressed patient participants (plasma HIV RNA <50 copies/mL)
timeFrame: 15 months (Baseline, Month 1, Month 3, Month 9 and Month 15)
measure: Injection Visit Show Rate
timeFrame: 15 months
measure: CAB+RPV LA effect on patient participants reported stigma
timeFrame: 15 months (Baseline, Month 7 & Month 15)
measure: CAB+RPV LA effect on patient participants reported treatment satisfaction
timeFrame: 15 months (Baseline, Month 7 & Month 15)
measure: Patient participants' reported change in treatment satisfaction between previous oral treatment and CAB+RPV LA
timeFrame: Month 15
measure: Reasons for CAB+RPV LA discontinuation
timeFrame: 15 months
Other outcomes:
measure: Describe patient reported barriers to receiving CAB+RPV LA
timeFrame: 15 months (Baseline, Month 7 and Month 15)
Locations:
city: Grand Island
country: United States
facility: Nebraska Medicine Grand Island Clinic
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Specialty Care Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Nada Fadul, MD
role: PRINCIPAL_INVESTIGATOR
References: