IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
- Conditions
- HIV
- Registration Number
- NCT06451341
- Lead Sponsor
- University of Nebraska
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient participants determination of acceptability of CAB+RPV LA implementation 15 months (baseline, month 7 & month 15) Proportion of patient participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Acceptability of Intervention Measure (AIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
Staff participants determination of the acceptability of CAB+RPV LA implementation 15 months (baseline, month 7 & month 15) Proportion of staff participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Acceptability of Intervention Measure (AIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
Staff participants determination of the feasibility of CAB+RPV LA implementation 15 months (baseline, month 7 & month 15) Proportion of staff participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Feasibility of Intervention Measure (FIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
Patient participants determination of feasibility of CAB+RPV LA implementation 15 months (baseline, month 7 & month 15) Proportion of patient participants that agree/completely agree (average score of 4 or higher) on the acceptability of CAB+RPV LA implementation on the Feasibility of Intervention Measure (FIM) questionnaire (4-item measure of perceived intervention acceptability measured on a Likert scale (1-Completely Disagree to 5-Completely Agree). Score is calculated mean.
- Secondary Outcome Measures
Name Time Method Injection Visit Show Rate 15 months Proportion of patient participants missing clinical injection visits (injection visit show rate collected at the end of study from the electronic medical record for each clinical injection).
Patient participants' reported change in treatment satisfaction between previous oral treatment and CAB+RPV LA Month 15 HIV Treatment Satisfaction Questionnaire change version (12 items rated using a 7-point Likert scale: -3 - much less satisfied now to 3 -much more satisfied now.) Higher scores indicate a greater improvement in treatment satisfaction with the new treatment.
CAB+RPV LA effect on patient participants reported treatment satisfaction 15 months (Baseline, Month 7 & Month 15) HIV Treatment Satisfaction Questionnaire status version (12 items rated using a 7-point Likert scale: 0 - very dissatisfied to 6 -very satisfied). Higher scores indicate a greater level of satisfaction with HIV treatment.
Site-specific barriers for CAB+RPV LA implementation 16 months Qualitative interviews with staff participants within one month of end of study
Virologically suppressed patient participants (plasma HIV RNA <50 copies/mL) 15 months (Baseline, Month 1, Month 3, Month 9 and Month 15) Proportion of patient participants who are virologically suppressed (plasma HIV RNA \<50 copies/mL) as a description of the effectiveness of CAB+RPV LA implementation strategies on viral suppression. Viral load results collected from the electronic medical record for the injection visits.
Site-specific facilitators for CAB+RPV LA implementation 16 months Qualitative interviews with staff participants within one month of end of study
CAB+RPV LA effect on patient participants reported stigma 15 months (Baseline, Month 7 & Month 15) HIV Stigma Questionnaire (12-item measure of perceived stigma using a 4-point Likert scale: 1-Completely Disagree to 4-Completely Agree; higher scores designate a greater level of perceived HIV-related stigma). Total score is the summation of item scores.
Reasons for CAB+RPV LA discontinuation 15 months Collection of reasons from patient participants for discontinuation of CAB+RPV LA will be completed at the end of patient study participation.
Site-specific reach of CAB+RPV LA implementation 15 months Comparison of the number of patients referred to start CAB+RPV LA to the number of patients who were clinically eligible to start CAB+RPV LA at end of study.
This data will be obtained from an electronic medical record generated report indicating the number of patients who meet initial clinical eligibility (virologically suppressed, not pregnant, no Hepatitis B infection, etc).
Trial Locations
- Locations (2)
Nebraska Medicine Grand Island Clinic
🇺🇸Grand Island, Nebraska, United States
University of Nebraska Specialty Care Center
🇺🇸Omaha, Nebraska, United States
Nebraska Medicine Grand Island Clinic🇺🇸Grand Island, Nebraska, United StatesMaureen Kubat, BSN, RNContact402-559-4408mo.kubat@unmc.edu