IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas: Addressing Adherence Barriers Through Learning and Evidence-Informed Strategies (IM-CAPABLE)
University of Nebraska
55 participants
Jul 1, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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
- 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
Exclusion Criteria6
- 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
Interventions
The Acceptability of Intervention Measure (AIM) questionnaire will be administered at Baseline, Month 7 and Month 15 to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a "leading indicator" of implementation success. The AIM will measure the extent to which participants believe CAB+RPV LA implementation is acceptable.
The Intervention Appropriateness Measure (IAM) questionnaire will be administered at Baseline to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a "leading indicator" of implementation success. The IAM will measure the extent to which participants believe CAB+RPV LA implementation is appropriate.
The Feasibility of Intervention Measure (FIM) questionnaire will be administered at Baseline, Month 7 and Month 15 to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a "leading indicator" of implementation success. The FIM will measure the extent to which participants believe CAB+RPV LA implementation is feasible.
The HIV Stigma Scale Questionnaire used in this study is a shortened version of the validated 40-item HIV stigma scale. This 12-item questionnaire measures the same four stigma subscales measured in the original version, for a streamlined approach to collecting this data on personalized stigma, disclosure concerns, concerns with public attitudes and negative self-image. This will be administered at Baseline, Month 7 and Month 15.
The HIV Treatment Satisfaction Questionnaire was developed to evaluate treatments for HIV and patient satisfaction. The original 10 item HIVTSQ, which underwent two stages of psychometric validation, has been adapted to include questions regarding injectable treatment for HIV. Two versions of the HIVTSQ are being used. The status version (HIVTSQs12) will assess change in treatment satisfaction over time, and the change version (HIVTSQc12) will assess the change in treatment satisfaction between a patient participant's previous and current treatment. The status version will be administered at Baseline, Month 7 and Month 15.
The HIV Treatment Satisfaction Questionnaire was developed to evaluate treatments for HIV and patient satisfaction. The original 10 item HIVTSQ, which underwent two stages of psychometric validation, has been adapted to include questions regarding injectable treatment for HIV. Two versions of the HIVTSQ are being used. The status version (HIVTSQs12) will assess change in treatment satisfaction over time, and the change version (HIVTSQc12) will assess the change in treatment satisfaction between a patient participant's previous and current treatment. The change version will be administered at Month 15.
The Needs and Barriers Assessment is a questionnaire designed to assess patient participant barriers and social determinants of health, emotional challenges related to antiretroviral therapy, and the impact of switching to CAB+RPV LA treatment. This will be administered at Baseline, Month 7 and Month 15.
Patient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment.
Qualitative interviews will be conducted within thirty days after study completion at Month 15 to further evaluate the participant's experience with the implementation of CAB+RPV LA treatment.
Staff participants will participate in Extension for Community Healthcare Outcomes (Project ECHO) educational sessions with topics such as fundamentals of HIV treatment and care, HIV outcomes, delivery of antiretroviral therapies (ART) including long-acting ART, cultural sensitivity, and social determinants of health in rural areas.
The Staff Burden and Engagement survey is a questionnaire designed to assess staff participant perceptions of engagement, burden, facilitators, barriers, communication, resources and challenges related to the implementation of long-acting injectable therapy at their clinic. This will be administered at Month 7 and Month 15.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06451341