IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas

HIV Clinical Trial

— IM-CAPABLE  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451341
• Other study ID #: 0277-24-EP
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: University of Nebraska
• Contact: Maureen Kubat, BSN, RN
• Phone: 402-559-4408
• Email: mo.kubat[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 by 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Acceptability of Intervention Measure (AIM)
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.
• Intervention Appropriateness Measure (IAM)
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.
• Feasibility of Intervention Measure (FIM)
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.
• HIV Stigma Scale Questionnaire
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.
• HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12)
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.
• HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12)
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.
• Needs and Barriers Assessment
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.
• Pre-visit Outreach
Patient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment.
• Qualitative interview
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 education
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.

Locations

Country	Name	City	State
United States	Nebraska Medicine Grand Island Clinic	Grand Island	Nebraska
United States	University of Nebraska Specialty Care Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Describe patient reported barriers to receiving CAB+RPV LA	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.	15 months (Baseline, Month 7 and Month 15)
Primary	Patient participants determination of acceptability of CAB+RPV LA implementation	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.	15 months (baseline, month 7 & month 15)
Primary	Patient participants determination of feasibility of CAB+RPV LA implementation	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.	15 months (baseline, month 7 & month 15)
Primary	Staff participants determination of the acceptability of CAB+RPV LA implementation	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.	15 months (baseline, month 7 & month 15)
Primary	Staff participants determination of the feasibility of CAB+RPV LA implementation	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.	15 months (baseline, month 7 & month 15)
Secondary	Site-specific reach of CAB+RPV LA implementation	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).	15 months
Secondary	Site-specific barriers for CAB+RPV LA implementation	Qualitative interviews with staff participants within one month of end of study	16 months
Secondary	Site-specific facilitators for CAB+RPV LA implementation	Qualitative interviews with staff participants within one month of end of study	16 months
Secondary	Virologically suppressed patient participants (plasma HIV RNA <50 copies/mL)	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.	15 months (Baseline, Month 1, Month 3, Month 9 and Month 15)
Secondary	Injection Visit Show Rate	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).	15 months
Secondary	CAB+RPV LA effect on patient participants reported stigma	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.	15 months (Baseline, Month 7 & Month 15)
Secondary	CAB+RPV LA effect on patient participants reported treatment satisfaction	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.	15 months (Baseline, Month 7 & Month 15)
Secondary	Patient participants' reported change in treatment satisfaction between previous oral treatment and CAB+RPV LA	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.	Month 15
Secondary	Reasons for CAB+RPV LA discontinuation	Collection of reasons from patient participants for discontinuation of CAB+RPV LA will be completed at the end of patient study participation.	15 months