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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06451341
Other study ID # 0277-24-EP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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