HIVIM-CAPABLENCT06451341
IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
An observational study of HIV, run by University of Nebraska at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2024to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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, the Nebraska Medicine Grand Island Clinic, the Myrtue Medical Center or the Shenandoah Medical Center who meet eligibility criteria. They will be contacted by email or phone for possible participation.
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, the Nebraska Medicine Grand Island Clinic, the Myrtue Medical Center, or the Shenandoah Medical Center 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Nebraska Medicine Grand Island Clinic
Grand Island, Nebraska, 68803
Myrtue Medical Center
Harlan, Iowa, 51537
University of Nebraska Specialty Care Center
Omaha, Nebraska, 68106
Shenandoah Medical Center
Shenandoah, Iowa, 51601
About this study
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)
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 interviews.
Read the 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 several rural facilities acting as satellite locations for patients to receive CAB+RPV LA injections: 1) the Nebraska Medicine Internal Medicine Clinic in Grand Island, Nebraska (located approximately 150 miles west of Omaha); 2) the Myrtue Medical Center in Harlan, Iowa (approximately 60 miles northeast of Omaha); and 3) the Shenandoah Medical Center in Shenandoah, Iowa (approximately 65 miles southeast of Omaha).
The IM-CAPABLE study aims to evaluate these partnerships 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 interviews.
- Conditions
- HIV
- Being tested
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), HIV Stigma Scale Questionnaire, HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12)
- Keywords
- CAB, RPV, Cabotegravir, Rilpivirine, Long acting injections, Rural, Antiretroviral therapy, HIV-1, Implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptability of Intervention Measure (AIM)Behavioural
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)Behavioural
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)Behavioural
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 QuestionnaireBehavioural
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)Behavioural
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)Behavioural
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 AssessmentBehavioural
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 OutreachBehavioural
Patient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment.
Qualitative interview - patient participantsBehavioural
Qualitative interviews will be conducted for all patient participants 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 educationBehavioural
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.
Staff Month 7 and 15 Survey - Staff Burden and EngagementBehavioural
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.
Qualitative interview - staffBehavioural
Qualitative interviews will be conducted at Baseline for staff at the Myrtue Medical Center and the Shenandoah Medical Center to evaluate participants' knowledge and perceptions about CAB+RPV LA. An interview will be conducted for all staff participants within thirty days after study completion at Month 15 to further evaluate the participant's experience with the implementation of CAB+RPV LA treatment.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care. Receives: Behavioral: Acceptability of Intervention Measure (AIM); Behavioral: Intervention Appropriateness Measure (IAM); Behavioral: Feasibility of Intervention Measure (FIM); Behavioral: HIV Stigma Scale Questionnaire; Behavioral: HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12); Behavioral: HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12); Behavioral: Needs and Barriers Assessment; Behavioral: Pre-visit Outreach; Behavioral: Qualitative interview - patient participants | |
| Staff | Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study. Receives: Behavioral: Acceptability of Intervention Measure (AIM); Behavioral: Intervention Appropriateness Measure (IAM); Behavioral: Feasibility of Intervention Measure (FIM); Behavioral: Staff education; Behavioral: Staff Month 7 and 15 Survey - Staff Burden and Engagement; Behavioral: Qualitative interview - staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months (baseline, month 7 & month 15)
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.
Measured: 15 months (baseline, month 7 & month 15)
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.
Measured: 15 months (baseline, month 7 & month 15)
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.
Measured: 15 months (baseline, month 7 & month 15)
Secondary outcomes (9)
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).
Measured: 15 months
Site-specific barriers for CAB+RPV LA implementation
Staff Burden and Engagement Survey administered at Month 7 and 15. Qualitative interviews with staff participants within one month of end of study.
Measured: 16 months
Site-specific facilitators for CAB+RPV LA implementation
Staff Burden and Engagement Survey administered at Month 7 and 15. Qualitative interviews with staff participants within one month of end of study.
Measured: 16 months
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.
Measured: 15 months (Baseline, Month 1, Month 3, Month 9 and Month 15)
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).
Measured: 15 months
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.
Measured: 15 months (Baseline, Month 7 & Month 15)
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.
Measured: 15 months (Baseline, Month 7 & Month 15)
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.
Measured: Month 15
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jul 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Nada Fadul, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451341
- Sponsor's protocol ID
- 0277-24-EP
- Acronym
- IM-CAPABLE
- Status last verified
- Oct 2025
- First submitted
- 20 May 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06451341
- Acronym / sponsor ID
- IM-CAPABLE / 0277-24-EP
- Conditions
- HIV
- Keywords
- CAB, RPV, Cabotegravir, Rilpivirine, Long acting injections, Rural, Antiretroviral therapy, HIV-1
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 interviews.
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 several rural facilities acting as satellite locations for patients to receive CAB+RPV LA injections: 1) the Nebraska Medicine Internal Medicine Clinic in Grand Island, Nebraska (located approximately 150 miles west of Omaha); 2) the Myrtue Medical Center in Harlan, Iowa (approximately 60 miles northeast of Omaha); and 3) the Shenandoah Medical Center in Shenandoah, Iowa (approximately 65 miles southeast of Omaha).
The IM-CAPABLE study aims to evaluate these partnerships 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 interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Behavioral: Acceptability of Intervention Measure (AIM), Behavioral: Intervention Appropriateness Measure (IAM), Behavioral: Feasibility of Intervention Measure (FIM), Behavioral: HIV Stigma Scale Questionnaire, Behavioral: HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12), Behavioral: HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12), Behavioral: Needs and Barriers Assessment, Behavioral: Pre-visit Outreach, Behavioral: Qualitative interview - patient participantsParticipants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care. |
| Staff | – | Behavioral: Acceptability of Intervention Measure (AIM), Behavioral: Intervention Appropriateness Measure (IAM), Behavioral: Feasibility of Intervention Measure (FIM), Behavioral: Staff education, Behavioral: Staff Month 7 and 15 Survey - Staff Burden and Engagement, Behavioral: Qualitative interview - staffStaff at the University of Nebraska Medical Center (UNMC) Specialty Care Center, the Nebraska Medicine Grand Island clinic, the Myrtue Medical Center or the Shenandoah Medical Center who provide HIV-related care and are involved in this study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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, the Nebraska Medicine Grand Island Clinic, the Myrtue Medical Center or the Shenandoah Medical Center who meet eligibility criteria. They will be contacted by email or phone for possible participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Participants, Staff |
| 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. | Behavioural | Participants, Staff |
| 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. | Behavioural | Participants, Staff |
| HIV Stigma Scale QuestionnaireThe 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. | Behavioural | Participants |
| 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. | Behavioural | Participants |
| 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. | Behavioural | Participants |
| Needs and Barriers AssessmentThe 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. | Behavioural | Participants |
| Pre-visit OutreachPatient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment. | Behavioural | Participants |
| Qualitative interview - patient participantsQualitative interviews will be conducted for all patient participants within thirty days after study completion at Month 15 to further evaluate the participant's experience with the implementation of CAB+RPV LA treatment. | Behavioural | Participants |
| Staff educationStaff 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. | Behavioural | Staff |
| Staff Month 7 and 15 Survey - Staff Burden and EngagementThe 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. | Behavioural | Staff |
| Qualitative interview - staffQualitative interviews will be conducted at Baseline for staff at the Myrtue Medical Center and the Shenandoah Medical Center to evaluate participants' knowledge and perceptions about CAB+RPV LA. An interview will be conducted for all staff participants within thirty days after study completion at Month 15 to further evaluate the participant's experience with the implementation of CAB+RPV LA treatment. | Behavioural | Staff |
Primary outcome
Patient participants determination of acceptability of CAB+RPV LA implementation
Time frame: 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.
Patient participants determination of feasibility of CAB+RPV LA implementation
Time frame: 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.
Staff participants determination of the acceptability of CAB+RPV LA implementation
Time frame: 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
Time frame: 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.
9 secondary outcomes
Site-specific reach of CAB+RPV LA implementation
Time frame: 15 months
Site-specific barriers for CAB+RPV LA implementation
Time frame: 16 months
Site-specific facilitators for CAB+RPV LA implementation
Time frame: 16 months
Virologically suppressed patient participants (plasma HIV RNA <50 copies/mL)
Time frame: 15 months (Baseline, Month 1, Month 3, Month 9 and Month 15)
Injection Visit Show Rate
Time frame: 15 months
CAB+RPV LA effect on patient participants reported stigma
Time frame: 15 months (Baseline, Month 7 & Month 15)
CAB+RPV LA effect on patient participants reported treatment satisfaction
Time frame: 15 months (Baseline, Month 7 & Month 15)
Patient participants' reported change in treatment satisfaction between previous oral treatment and CAB+RPV LA
Time frame: Month 15
Reasons for CAB+RPV LA discontinuation
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada Fadul, MD principal investigator
University of Nebraska
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of Nebraska at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient participants determination of acceptability of CAB+RPV LA implementation (time frame: 15 months (baseline, month 7 & month 15)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.