A Phase 3 interventional study of CAB OLI and CAB LA in HIV Infections, sponsored by ViiV Healthcare. Completed at 18 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants [PSP]) as well as the healthcare providers at the investigator site level (staff study participants [SSP]). SSPs consists of 2 groups: standard and enhanced arm.
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This study's enrollment of 437 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
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A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test at screen and at Day 1), not lactating, and at least one of the following conditions applies:
Non-reproductive potential is defined as:
Pre-menopausal females with one of the following:
Exclusion criteria:
Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows:
Participants with HCV co-infection will be allowed entry into this study if:
In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility:
(Age times Aspartate aminotransferase [AST]) / (Platelets times (square [Alanine aminotransferase]{ALT}).
Treatment with any of the following agents within 28 days of Day 1:
HIV-infected participants will receive CAB LA + RPV LA regimen for a month of oral lead in (OLI) at Day 1 followed by CAB LA + RPV LA injections at Months 1 and 2 and every 2 months (Q2M) thereafter.
Drug: CAB OLI · Drug: CAB LA · Drug: RPV OLI · Drug: RPV LA
Staff study participants will be randomized to receive standard implementation support (Arm-S; through visit(s) with the medication lead in their country, education on the medication, and patient and staff education/support materials) or through enhanced implementation support (Arm-E; through the addition of continuous quality improvement during the study).
Other: Continuous Quality Improvement (CQI) calls
CAB will be available as 30 milligrams (mg) tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
CAB LA 600 mg will be administered as intramuscular (IM) injection.
RPV will be available as 25 mg tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
RPV LA 900 mg will be administered as IM injection.
CQI will be attended by the enhanced arm (Arm-E). The CQI calls will be conducted to identify problems/challenges, generate plans to address the challenges, and identify how to measure the change that results from the plan.
Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12
The AIM-Imp was designed to assess the acceptability of an implementation process (i.e., perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). The measure consists of four items/statements (1. The implementation support thus far meets my approval 2. The implementation support thus far is appealing to me 3. I like the implementation support I have received 4. I welcome implementation support for the CAB + RPV injection treatment), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.
Time frame: Baseline (Month 1) and Month 12
Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12
The IAM-Imp is designed to assess the appropriateness of an implementation process (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer, and the perceived fit of the innovation to address a particular issue or problem). The IAM-Imp is a four-item/statement measure (1. The implementation support thus far seems fitting 2. The implementation support seems suitable for using the CAB + RPV injection treatment 3. The implementation support seems applicable for the CAB + RPV injection treatment 4. The implementation support seems like a good match) with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.
Time frame: Baseline (Month 1) and Month 12
Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12
The FIM-Imp was a four-item/statement measure (1. The implementation support seems implementable in our clinic/practice 2. The implementation support seems possible in our clinic/practice 3. The implementation support seems doable in our clinic/practice 4. The implementation support seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.
Time frame: Baseline (Month 1) and Month 12
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
Time frame: Up to 12 Months
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
Time frame: Up to Month 12
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
Time frame: Up to Month 12
Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs)
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12
The ILS is a 12-item (facilitate implementation, obstacles, clear department standards, knowledge, ability to answer questions, awareness of concept, recognition, support employee efforts to learn, support employee efforts to use intervention, persevere(s) through the ups and downs, carries on through the challenges and reaction to criticial issues) measure that assesses SSP understanding of the degree to which leadership in their clinic/practice setting is proactive, knowledgeable, supportive, and perseverant with regards to implementing the CAB LA + RPV LA injection treatment in their settings. The items are measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less understanding in leadership.
Time frame: Baseline (Month 1) and Month 12
Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12
The ICS is a 9 item (team's main goals, importance of implementation, top priority, workshops, treatment training, training material, staff adaptability, flexibility, openness to new intervention) measure that assesses SSPs' perceptions of their team (i.e., the people that they work with) while using the CAB LA + RPV LA injection treatment in their clinic/practice setting. The items were measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less seriousness for implementation in staff.
Time frame: Month 1 and Month 12
Number of Modifications Reported by SSPs Assessed Via FRAME-IS
The Framework for Reporting Adaptations and Modifications to Evidence-based interventions - Implementation Strategies (FRAME-IS) was a seven-question measure (contained both open and closed categorical questions) used to record details the modifications made to the implementation of the CAB LA + RPV LA injection treatment procedures.
Time frame: Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course
CQI were a 60 minutes calls involved working through a plan to address the identified barriers, optimize processes, and evaluate these efforts. This process of addressing barriers was guided by a series of Plan, Do, Study, Act (PDSA) cycles. Number of PDSA cycles developed are presented.
Time frame: Month 2 to Month 7
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 20 Minutes, Up to 40 Minutes, Up to 60 Minutes, Up to 90 Minutes, More than 90 Minutes and missing. Missing include participants who did not provide a response for the question.
Time frame: Up to Month 12
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 10 Minutes, 11-20 Minutes, 21-30 Minutes, 31-45 Minutes, More than 45 Minutes and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as Whole day annual leave, Half day annual leave, Whole day sick leave, Half day sick leave, Whole day unpaid, Half day unpaid, Other, Not taken time off and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Up to 15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes, More than 60 minutes, and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Yes, No, Not Applicable and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Taxi- Transportation service, Dropped-off, Private vehicle, Bicycle/scooter/ skateboard/ walked, Public transport and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as No, Yes - On the day of receiving the treatment, Yes - One day after receiving the treatment, Yes-Two days after receiving the treatment, Yes-More than two days after receiving the treatment, Not Applicable, Missing and Missing Response for 'Yes'. Missing include participants who did not provide a response for the question. Missing Response for 'Yes' include participants who responded 'Yes' but did not provide duration of time off.
Time frame: Month 12
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The convenience responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, Not applicable; I did not have to reschedule and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely positive, Very positive, Somewhat positive, A little positive, Not at all positive and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely knowledgeable, Very knowledgeable, Somewhat knowledgeable, A little knowledgeable, Not at all knowledgeable and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question.The responses were categorized as Phone calls, Text/SMS messages, Existing clinic app, E-mail, Reminder in the mail, Another reminder and I did not receive reminders. The responses are not mutually exclusive.
Time frame: Month 12
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely helpful, Very helpful, Somewhat helpful, A Little helpful, Not at all helpful and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Completely agree, Agree, Neutral, Disagree, Completely disagree and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Take over-the-counter pain relievers, Use a hot compress, Use a cold compress, Avoid sitting for long periods of time, Light stretching and exercise, None of the above, Other and I don't get sore after my injections.
Time frame: Month 12
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs)
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for acceptability are presented.
Time frame: Up to Month 12
Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for acceptability are presented.
Time frame: Up to Month 12
Number of PSPs That Discussed Facilitators for Appropriateness Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for appropriateness are presented.
Time frame: Up to Month 12
Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs with barriers for appropriateness are presented.
Time frame: Up to Month 12
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for feasibility are presented.
Time frame: Up to Month 12
Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for feasibility are presented.
Time frame: Up to Month 12
Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12
AIM assesses the acceptability of an intervention (i.e., perception among stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). It is a four-item (1. The CAB+RPV injection treatment meets my approval for treating my HIV, 2. The CAB+RPV injection treatment is appealing to me, 3. I like the CAB+RPV injection treatment for my HIV, 4. I welcome the CAB+RPV injection treatment for my HIV) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.
Time frame: Baseline (Month 1) and Month 12
Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12
IAM assesses the appropriateness of an intervention (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and the perceived fit of the innovation to address a particular issue or problem). It is a four-item (1. The CAB+RPV injection treatment is fitting for my life, 2. The CAB+RPV injection treatment is suitable for my life, 3. The CAB+RPV injection treatment is applicable to my life, 4. The CAB+RPV injection treatment is a good match for my life) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.
Time frame: Baseline (Month 1) and Month 12
Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12
The four-item (1. The CAB+RPV injection treatment seems implementable in my life 2. The CAB+RPV injection treatment every 2 months is possible for me to use 3. The CAB+RPV injection treatment every 2 months seems doable in my life 4. The CAB+RPV injection treatment every 2 months seems easy to use in my life). FIM assesses perceived intervention feasibility. The items are measured on a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.
Time frame: Baseline (Month 1) and Month 12
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12
The APCSAT is a 35-item measure that assesses SSP impressions of the data in their clinic. Sustainability refers to the ability to maintain and expand the CAB LA + RPV LA injection treatment and its benefits over time. SSPs were asked to rate their clinic/practice along a range of specific domains that affect sustainability, including: 'Engages Staff \& Leadership,' 'Engaging Stakeholders,' 'Monitoring and Evaluation,' 'Implementation \& Training,' 'Outcomes \& Effectiveness,' 'Workflow Integration,' and 'Organizational Readiness.' Five items were presented to SSPs in each section. The items were measured on a seven-point rating scale (1 = little to no extent to 7 = to a very great extent. Domain total was divided by the total number of items with a score to get average score.
Time frame: Month 12
Percentage of PSP Receiving Injections Within Target Window
The target window for participants to receive injection was from Day -7 to Day 7.
Time frame: Day -7 to Day 7 of Month 2, 4, 6, 8, 10 and 12
Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml)
Plasma samples were collected from the participant at specific time points.
Time frame: Month 1, 2, 4, 8 and 12
Number of Participants With Confirmed Virologic Failure (CVF) Over Time
CVF was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/ml.
Time frame: Month 1, 2, 4, 8, 10 and 12
Number of PSPs With Adverse Events (AEs) And Serious AEs (SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
Time frame: Up to 12 Months
Number of PSPs Discontinuing Treatment Due to AEs
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: Up to 12 Months
Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire
PSPs were asked to think about their experience of using the long-acting injectable medication versus the daily oral HIV medication, and to select their preferred treatment and all the reasons that support their preference. Results are categorized as: 'long-acting injectable HIV medication', 'daily oral HIV medication', 'no preference', Missing and Erroneous. Missing include participants who did not provide a response for the question. PSPs who completed this question incorrectly (i.e., checked reasons without a ticking a leading preference or checked more than one leading preference box) were included in Erroneous.
Time frame: Up to 12 Months
A total of 437 patient study participants (PSPs) \[people living with HIV\] were enrolled. 430 PSP received study treatment and were included in the safety population. Staff Study Participants (SSP) (HIV care providers, nurses/staff performing injections administrators/clinic managers) were not counted as enrolled. SSP were randomized based on implementation strategy - Enhanced (Arm-E) and Standard (Arm -S).
| Milestone | Patient Study Participants |
|---|---|
| Started | 430 |
| Completed | 402 |
| Not completed | 28 |
| Withdrew: Adverse event | 15 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Physician decision | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Protocol deviation | 2 |
The AIM-Imp was designed to assess the acceptability of an implementation process (i.e., perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). The measure consists of four items/statements (1. The implementation support thus far meets my approval 2. The implementation support thus far is appealing to me 3. I like the implementation support I have received 4. I welcome implementation support for the CAB + RPV injection treatment), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.
| Scores on a scale | Staff Study Participants - Enhanced Implementation Arm | Staff Study Participants - Standard Implementation Arm |
|---|---|---|
| Baseline (Month 1) | 3.8 ± 0.76 | 3.9 ± 0.75 |
| Month 12 | 0.28 ± 0.828 | 0.33 ± 0.666 |
The IAM-Imp is designed to assess the appropriateness of an implementation process (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer, and the perceived fit of the innovation to address a particular issue or problem). The IAM-Imp is a four-item/statement measure (1. The implementation support thus far seems fitting 2. The implementation support seems suitable for using the CAB + RPV injection treatment 3. The implementation support seems applicable for the CAB + RPV injection treatment 4. The implementation support seems like a good match) with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.
| Scores on a scale | Staff Study Participants-Enhanced Implementation Arm | Staff Study Participants - Standard Implementation Arm |
|---|---|---|
| Baseline (Month 1) | 3.8 ± 0.78 | 3.9 ± 0.78 |
| Month 12 | 0.22 ± 0.740 | 0.31 ± 0.729 |
The FIM-Imp was a four-item/statement measure (1. The implementation support seems implementable in our clinic/practice 2. The implementation support seems possible in our clinic/practice 3. The implementation support seems doable in our clinic/practice 4. The implementation support seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.
| Scores on a scale | Staff Study Participants - Enhanced Implementation Arm | Staff Study Participants - Standard Implementation Arm |
|---|---|---|
| Baseline (Month 1) | 4.0 ± 0.66 | 4.0 ± 0.64 |
| Month 12 | 0.06 ± 1.047 | 0.34 ± 0.773 |
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Improved Patient's Quality of Life | 0 | 1 |
| Injection pain management | 2 | 0 |
| No commute to clinic | 1 | 3 |
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs | 1 | 1 |
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Patient characteristics | 1 | 2 |
| Patient selection | 0 | 2 |
| Hours of home visit | 1 | 1 |
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs | 0 | 0 |
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Clinic or unit characteristics (e.g., autonomy, size, flexibility) | 2 | 3 |
| Experience with the medication | 0 | 1 |
| Implementation processes | 2 | 2 |
| Medication storage | 2 | 1 |
| Number of patients | 1 | 2 |
| Nursing staff in consultation department | 0 | 1 |
| Pharmacy flexibility | 0 | 1 |
| Room/space characteristics | 1 | 1 |
| Staff availability | 0 | 2 |
| Staff characteristics (e.g., experience, qualification, motivation) | 6 | 8 |
| Training | 1 | 0 |
| ViiV support and materials | 3 | 1 |
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs | 0 | 0 |
The ILS is a 12-item (facilitate implementation, obstacles, clear department standards, knowledge, ability to answer questions, awareness of concept, recognition, support employee efforts to learn, support employee efforts to use intervention, persevere(s) through the ups and downs, carries on through the challenges and reaction to criticial issues) measure that assesses SSP understanding of the degree to which leadership in their clinic/practice setting is proactive, knowledgeable, supportive, and perseverant with regards to implementing the CAB LA + RPV LA injection treatment in their settings. The items are measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less understanding in leadership.
| Scores on a scale | Staff Study Participants - Enhanced Implementation Arm | Staff Study Participants - Standard Implementation Arm |
|---|---|---|
| Baseline (Month 1) | 2.3 ± 0.86 | 2.0 ± 0.81 |
| Month 12 | -0.1 ± 1.19 | 0.2 ± 0.51 |
The ICS is a 9 item (team's main goals, importance of implementation, top priority, workshops, treatment training, training material, staff adaptability, flexibility, openness to new intervention) measure that assesses SSPs' perceptions of their team (i.e., the people that they work with) while using the CAB LA + RPV LA injection treatment in their clinic/practice setting. The items were measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less seriousness for implementation in staff.
| Scores on a scale | Staff Study Participants - Enhanced Implementation Arm | Staff Study Participants - Standard Implementation Arm |
|---|---|---|
| Month 1 | 2.5 ± 0.65 | 2.8 ± 0.80 |
| Month 12 | 2.7 ± 0.72 | 2.6 ± 0.80 |
The Framework for Reporting Adaptations and Modifications to Evidence-based interventions - Implementation Strategies (FRAME-IS) was a seven-question measure (contained both open and closed categorical questions) used to record details the modifications made to the implementation of the CAB LA + RPV LA injection treatment procedures.
| Number of Modifications | Staff Study Participants - Enhanced Implementation Arm | Staff Study Participants - Standard Implementation Arm |
|---|---|---|
| Month 2 | 15 | 7 |
| Month 3 | 10 | 2 |
| Month 4 | 5 | 2 |
| Month 5 | 1 | 1 |
| Month 6 | 3 | 0 |
| Month 7 | 4 | 0 |
| Month 8 | 0 | 0 |
| Month 9 | 3 | 0 |
| Month 10 | 0 | 0 |
| Month 11 | 3 | 1 |
| Month 12 | 0 | 1 |
CQI were a 60 minutes calls involved working through a plan to address the identified barriers, optimize processes, and evaluate these efforts. This process of addressing barriers was guided by a series of Plan, Do, Study, Act (PDSA) cycles. Number of PDSA cycles developed are presented.
| Cycles | Staff Study Participants (SSP) |
|---|---|
| Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course | 23 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 20 Minutes, Up to 40 Minutes, Up to 60 Minutes, Up to 90 Minutes, More than 90 Minutes and missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Up to 20 Minutes | 71 |
| Up to 40 Minutes | 134 |
| Up to 60 Minutes | 99 |
| Up to 90 Minutes | 48 |
| More than 90 Minutes | 19 |
| Missing | 8 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 10 Minutes, 11-20 Minutes, 21-30 Minutes, 31-45 Minutes, More than 45 Minutes and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Up to 10 Minutes | 190 |
| 11-20 Minutes | 100 |
| 21-30 Minutes | 54 |
| 31-45 Minutes | 25 |
| More than 45 Minutes | 5 |
| Missing | 5 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Extremely acceptable | 140 |
| Very acceptable | 151 |
| Somewhat acceptable | 72 |
| A little acceptable | 11 |
| Not at all acceptable | 0 |
| Missing | 5 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Extremely acceptable | 163 |
| Very acceptable | 154 |
| Somewhat acceptable | 51 |
| A little acceptable | 6 |
| Not at all acceptable | 0 |
| Missing | 5 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as Whole day annual leave, Half day annual leave, Whole day sick leave, Half day sick leave, Whole day unpaid, Half day unpaid, Other, Not taken time off and missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Whole day annual leave | 27 |
| Half day annual leave | 20 |
| Whole day sick leave | 5 |
| Half day sick leave | 3 |
| Whole day unpaid | 9 |
| Half day unpaid | 20 |
| Other | 64 |
| Not taken Time Off | 222 |
| Missing | 9 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Up to 15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes, More than 60 minutes, and missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Up to 15 minutes | 66 |
| 16-30 minutes | 138 |
| 31-45 minutes | 87 |
| 46-60 minutes | 44 |
| More than 60 minutes | 39 |
| Missing | 5 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Yes, No, Not Applicable and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Yes | 16 |
| No | 318 |
| Not Applicable | 39 |
| Missing | 6 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Taxi- Transportation service, Dropped-off, Private vehicle, Bicycle/scooter/ skateboard/ walked, Public transport and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Taxi-Transportation service | 13 |
| Dropped-off | 12 |
| Private vehicle | 164 |
| Bicycle/ scooter/ skateboard/ walked | 49 |
| Public transport | 138 |
| Missing | 3 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as No, Yes - On the day of receiving the treatment, Yes - One day after receiving the treatment, Yes-Two days after receiving the treatment, Yes-More than two days after receiving the treatment, Not Applicable, Missing and Missing Response for 'Yes'. Missing include participants who did not provide a response for the question. Missing Response for 'Yes' include participants who responded 'Yes' but did not provide duration of time off.
| Participants | Patient Study Participants |
|---|---|
| No | 294 |
| Yes, on the day of receiving the treatment | 45 |
| Yes, one day after receiving the treatment | 9 |
| Yes, two days after receiving the treatment | 7 |
| Yes, more than two days after receiving the treatment | 5 |
| Not Applicable | 16 |
| Missing | 5 |
| Missing response for 'Yes' | 2 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The convenience responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Extremely convenient | 175 |
| Very convenient | 154 |
| Somewhat convenient | 43 |
| A little convenient | 4 |
| Not at all convenient | 0 |
| Missing | 3 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, Not applicable; I did not have to reschedule and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Extremely convenient | 158 |
| Very convenient | 153 |
| Somewhat convenient | 25 |
| A little convenient | 2 |
| Not at all convenient | 0 |
| Not applicable; I did not have to schedule | 39 |
| Missing | 2 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely positive, Very positive, Somewhat positive, A little positive, Not at all positive and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Extremely positive | 234 |
| Very positive | 112 |
| Somewhat positive | 23 |
| A little positive | 4 |
| Not at all positive | 0 |
| Missing | 6 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely knowledgeable, Very knowledgeable, Somewhat knowledgeable, A little knowledgeable, Not at all knowledgeable and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Extremely knowledgeable | 124 |
| Very knowledgeable | 188 |
| Somewhat knowledgeable | 57 |
| A little knowledgeable | 6 |
| Not at all knowledgeable | 0 |
| Missing | 4 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question.The responses were categorized as Phone calls, Text/SMS messages, Existing clinic app, E-mail, Reminder in the mail, Another reminder and I did not receive reminders. The responses are not mutually exclusive.
| Participants | Patient Study Participants |
|---|---|
| Phone calls | 80 |
| Text/SMS messages | 275 |
| Existing clinic app | 48 |
| 161 | |
| Reminder in the mail | 21 |
| Another reminder | 3 |
| I did not receive reminders | 14 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely helpful, Very helpful, Somewhat helpful, A Little helpful, Not at all helpful and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Extremely helpful | 135 |
| Very helpful | 123 |
| Somewhat helpful | 50 |
| A Little helpful | 38 |
| Not at all helpful | 28 |
| Missing | 5 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Completely agree, Agree, Neutral, Disagree, Completely disagree and Missing. Missing include participants who did not provide a response for the question.
| Participants | Patient Study Participants |
|---|---|
| Completely agree | 283 |
| Agree | 75 |
| Neutral | 15 |
| Disagree | 1 |
| Completely disagree | 1 |
| Missing | 4 |
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Take over-the-counter pain relievers, Use a hot compress, Use a cold compress, Avoid sitting for long periods of time, Light stretching and exercise, None of the above, Other and I don't get sore after my injections.
| Participants | Patient Study Participants |
|---|---|
| Take over-the-counter pain relievers | 139 |
| Use a hot compress | 20 |
| Use a cold compress | 19 |
| Avoid sitting for long periods of time | 87 |
| Light stretching and exercise | 71 |
| None of the above | 61 |
| Other | 31 |
| I don't get sore after my injections | 72 |
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for acceptability are presented.
| Participants | Patient Study Participants |
|---|---|
| Feeling informed about CAB+RPV LA injection | 105 |
| Overall positive experience with CAB+RPV LA | 100 |
| Acceptable overall experience at clinic | 82 |
| In-person communication with HCP | 76 |
| Not thinking and/or worrying about taking medication | 66 |
| Experienced injector | 64 |
| Acceptable clinic hours to receive CAB+RPV LA injections | 51 |
| CAB+RPV LA injection experience met expectations | 43 |
| Patient travel facilitation | 33 |
| CAB+RPV LA injection experience better than expected | 32 |
| Staff responsiveness | 34 |
| Number of visits | 30 |
| Satisfaction with rescheduling process | 29 |
| Distance to clinic | 27 |
| Not being reminded about HIV | 26 |
| Acceptable time spent in clinic | 25 |
| Treatment adherence | 24 |
| Gaining a sense of freedom | 24 |
| Discreet treatment | 23 |
| Communication with staff | 22 |
| Reduced stigma due to CAB+RPV LA injection | 22 |
| Reduction in injection pain | 20 |
| [Patient-perspective] Medication for injection pain management | 19 |
| Reduced stress or worry due to CAB+RPV LA injection | 19 |
| HCP advice on pain management | 18 |
| [Patient-perspective] Activities to avoid for injection pain management | 16 |
| Website and/or internet | 15 |
| Characteristics of HCP communication | 14 |
| Written materials and brochures | 14 |
| Study materials | 14 |
| Time of informing | 13 |
| Medication collection, storage and/or preparation | 12 |
| Fewer side effects | 12 |
| Time-saving approach | 12 |
| [Patient-perspective] Activities to do for injection pain management | 11 |
| Administration in other clinical setting | 11 |
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for acceptability are presented.
| Participants | Patient Study Participants |
|---|---|
| Injection side effects including pain (Topic - Treatment Components Difficult for PSP) | 67 |
| Injection side effects including pain (Topic-Experienced Challenges to Receive CAB+PRV LA Injection) | 33 |
| CAB+RPV LA injection experience worse than expected | 11 |
| Waiting time | 11 |
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for appropriateness are presented.
| Participants | Patient Study Participants |
|---|---|
| Number of PSPs That Discussed Facilitators for Appropriateness Assessed Via SSIs | 0 |
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs with barriers for appropriateness are presented.
| Participants | Patient Study Participants |
|---|---|
| Patient fearing or squeamish about injections | 22 |
| Patients not tolerating intramuscular injection | 12 |
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for feasibility are presented.
| Participants | Patient Study Participants |
|---|---|
| Person to contact during CARISEL study | 102 |
| [Patient-perspective] Calendar, Diary, Notes and/or Reminders | 69 |
| No missed appointment and/or rescheduling | 65 |
| Target date explained | 57 |
| Easy to contact | 57 |
| Contacting clinic staff during CARISEL study | 52 |
| Home administration by HCP | 41 |
| No issues due to transportation and/or parking | 37 |
| No challenges to receive CAB+RPV LA injection | 33 |
| Not contacting clinic staff during CARISEL study | 31 |
| No issues due to work | 28 |
| Clinic Reminder [all types] | 27 |
| Term of target date helpful | 25 |
| [Patient-perspective] Setting reminders | 23 |
| CAB+RPV LA administration at GP office | 22 |
| CAB+RPV LA administration at nurse office and/or healthcare centers | 19 |
| No issues to attend visits due to childcare or family commitments | 16 |
| [Patient-perspective] Arrangements at work | 16 |
| Clinic reminder: Text and/or SMS | 14 |
| [Patient-perspective] Appointment scheduling strategies | 14 |
| No issues due to clinic hours | 13 |
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for feasibility are presented.
| Participants | Patient Study Participants |
|---|---|
| Target date not explained | 38 |
| Missed appointment and/or rescheduling | 23 |
| Issues due to work | 21 |
| Issues due to transportation and/or parking | 14 |
AIM assesses the acceptability of an intervention (i.e., perception among stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). It is a four-item (1. The CAB+RPV injection treatment meets my approval for treating my HIV, 2. The CAB+RPV injection treatment is appealing to me, 3. I like the CAB+RPV injection treatment for my HIV, 4. I welcome the CAB+RPV injection treatment for my HIV) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.
| Scores on a scale | Patient Study Participants |
|---|---|
| Baseline (Month 1) | 4.55 ± 0.666 |
| Month 12 | 0.10 ± 0.834 |
IAM assesses the appropriateness of an intervention (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and the perceived fit of the innovation to address a particular issue or problem). It is a four-item (1. The CAB+RPV injection treatment is fitting for my life, 2. The CAB+RPV injection treatment is suitable for my life, 3. The CAB+RPV injection treatment is applicable to my life, 4. The CAB+RPV injection treatment is a good match for my life) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.
| Scores on a scale | Patient Study Participants |
|---|---|
| Baseline (Month 1) | 4.47 ± 0.762 |
| Month 12 | 0.13 ± 0.928 |
The four-item (1. The CAB+RPV injection treatment seems implementable in my life 2. The CAB+RPV injection treatment every 2 months is possible for me to use 3. The CAB+RPV injection treatment every 2 months seems doable in my life 4. The CAB+RPV injection treatment every 2 months seems easy to use in my life). FIM assesses perceived intervention feasibility. The items are measured on a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.
| Scores on a scale | Patient Study Participants |
|---|---|
| Baseline (Month 1) | 4.51 ± 0.672 |
| Month 12 | 0.07 ± 0.857 |
The APCSAT is a 35-item measure that assesses SSP impressions of the data in their clinic. Sustainability refers to the ability to maintain and expand the CAB LA + RPV LA injection treatment and its benefits over time. SSPs were asked to rate their clinic/practice along a range of specific domains that affect sustainability, including: 'Engages Staff \& Leadership,' 'Engaging Stakeholders,' 'Monitoring and Evaluation,' 'Implementation \& Training,' 'Outcomes \& Effectiveness,' 'Workflow Integration,' and 'Organizational Readiness.' Five items were presented to SSPs in each section. The items were measured on a seven-point rating scale (1 = little to no extent to 7 = to a very great extent. Domain total was divided by the total number of items with a score to get average score.
| Scores on a scale | Staff Study Participants - Enhanced Implementation Arm | Staff Study Participants - Standard Implementation Arm |
|---|---|---|
| Engages Staff & Leadership | 5.57 ± 0.72 | 5.58 ± 0.49 |
| Engaging Stakeholders | 5.00 ± 1.06 | 5.05 ± 0.79 |
| Monitoring and Evaluation | 5.37 ± 0.16 | 5.49 ± 0.11 |
| Implementation & Training | 5.62 ± 0.56 | 5.56 ± 0.43 |
| Outcomes & Effectiveness | 5.39 ± 0.70 | 5.41 ± 0.69 |
| Workflow Integration | 5.46 ± 0.35 | 5.23 ± 0.34 |
| Organizational Readiness | 5.30 ± 0.32 | 5.05 ± 0.36 |
The target window for participants to receive injection was from Day -7 to Day 7.
| Percentage of Participants | Patient Study Participants |
|---|---|
| Month 2 | 99 |
| Month 4 | 93 |
| Month 6 | 91 |
| Month 8 | 91 |
| Month 10 | 94 |
| Month 12 | 91 |
Plasma samples were collected from the participant at specific time points.
| Percentage of Participants | Patient Study Participants |
|---|---|
| Month 1 | 99 (97.0 to 99.5) |
| Month 2 | 96 (93.7 to 97.7) |
| Month 4 | 93 (90.5 to 95.4) |
| Month 8 | 86 (82.7 to 89.4) |
| Month 12 | 87 (83.2 to 89.8) |
CVF was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/ml.
| Participants | Patient Study Participants |
|---|---|
| Month 1 | 0 |
| Month 2 | 0 |
| Month 4 | 0 |
| Month 6 | 0 |
| Month 8 | 0 |
| Month 10 | 1 |
| Month 12 | 0 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
| Participants | Patient Study Participants |
|---|---|
| Any AEs | 420 |
| Any SAEs | 15 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
| Participants | Patient Study Participants |
|---|---|
| Number of PSPs Discontinuing Treatment Due to AEs | 2 |
PSPs were asked to think about their experience of using the long-acting injectable medication versus the daily oral HIV medication, and to select their preferred treatment and all the reasons that support their preference. Results are categorized as: 'long-acting injectable HIV medication', 'daily oral HIV medication', 'no preference', Missing and Erroneous. Missing include participants who did not provide a response for the question. PSPs who completed this question incorrectly (i.e., checked reasons without a ticking a leading preference or checked more than one leading preference box) were included in Erroneous.
| Participants | Patient Study Participants |
|---|---|
| Daily oral HIV medication | 2 |
| Long-acting injectable HIV medication | 275 |
| No preference | 0 |
| Missing | 2 |
| Erroneous | 100 |
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Positive opinion about CAB+RPV LA | 28 | 28 |
| Negative opinion about CAB+RPV LA | 0 | 0 |
| Ambivalent opinion about CAB+RPV LA | 3 | 1 |
| Opinion about CAB+RPV LA did not change | 15 | 14 |
| Opinion about CAB+RPV LA changed | 9 | 11 |
| Treatment and/or its implementation is better than expected | 7 | 11 |
| Treatment and/or its implementation is worse than expected | 2 | 0 |
| Implementation facilitators reported | 16 | 19 |
| Did NOT encounter resistance to using CAB+RPV LA | 8 | 19 |
| ADMINISTRATION OUTSIDE CLINIC: Other clinical settings | 15 | 15 |
| ADMINISTRATION OUTSIDE CLINIC: Self-administered | 20 | 23 |
| What would do differently | 2 | 4 |
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| Implementation facilitators reported | 16 | 19 |
| ADMINISTRATION OUTSIDE CLINIC: Home administration by HCP | 24 | 19 |
| What would do differently | 2 | 4 |
| Recommended strategies to support patient adherence | 20 | 22 |
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
| Participants | Staff Study Participants - Standard Implementation Arm | Staff Study Participants - Enhanced Implementation Arm |
|---|---|---|
| No changes made to accommodate clinic needs | 10 | 7 |
| Changes made to accommodate clinic needs | 22 | 22 |
| Implementation facilitators reported | 16 | 19 |
| Developed supplemental materials for implementation | 3 | 5 |
| Staffing and workload issues was not a challenge | 12 | 7 |
| Staffing and workload issues was a challenge | 18 | 14 |
| Staffing and workload issues: How tried to/overcame this challenge | 7 | 10 |
| Staffing and workload issues: Still a challenge | 7 | 4 |
| Staffing and workload issues: Not a challenge at present | 8 | 5 |
| Availability of rooms and designated space: Was not a challenge | 19 | 15 |
| Availability of rooms and designated space: Was a challenge | 13 | 7 |
| Availability of rooms and designated space: How overcame this challenge | 9 | 7 |
| Availability of rooms and designated space: Still a challenge | 8 | 4 |
| Availability of rooms and designated space: Not a challenge at present | 4 | 3 |
| Coordination between the clinic and pharmacy: Was not a challenge | 23 | 17 |
| Coordination between the clinic and pharmacy: Was a challenge | 4 | 9 |
| Coordination between the clinic and pharmacy: How overcame this challenge | 3 | 6 |
| Coordination between the clinic and pharmacy: Still a challenge | 3 | 3 |
| Coordination between the clinic and pharmacy: Not a challenge at present | 0 | 4 |
| Medication supply and storage: Was not a challenge | 16 | 15 |
| Medication supply and storage: Was a challenge | 9 | 3 |
| Medication supply and storage: How tried to/overcame this challenge | 7 | 2 |
| Medication supply and storage: Still a challenge | 2 | 1 |
| Medication supply and storage: Not a challenge at present | 5 | 2 |
| Being able to administer injections: Was not a challenge | 24 | 17 |
| Being able to administer injections: Was a challenge | 3 | 3 |
| Being able to administer injections: How overcame this challenge | 1 | 3 |
| Being able to administer injections: Still a challenge | 1 | 2 |
| Being able to administer injections: Not a challenge at present | 2 | 1 |
| Being able to administer injections: ViiV not supportive of CAB+RPV LA implementation | 0 | 5 |
| Being able to administer injections: ViiV supportive of CAB+RPV LA implementation | 31 | 23 |
| Being able to administer injections: What would do differently | 2 | 4 |
Collected over Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Study Participants | 0/430 (0%) | 17/430 (4%) | 384/430 (89.3%) |
| Event | Patient Study Participants |
|---|---|
| AppendicitisInfections and infestations | 1/430 |
| COVID-19Infections and infestations | 1/430 |
| PeritonitisInfections and infestations | 1/430 |
| Yersinia infectionInfections and infestations | 1/430 |
| Abdominal painGastrointestinal disorders | 1/430 |
| Appendicitis noninfectiveGastrointestinal disorders | 1/430 |
| Clavicle fractureInjury, poisoning and procedural complications | 1/430 |
| Subdural haematomaInjury, poisoning and procedural complications | 1/430 |
| Subdural haemorrhageInjury, poisoning and procedural complications | 1/430 |
| Major depressionPsychiatric disorders | 1/430 |
| Event | Patient Study Participants |
|---|---|
| Injection site painGeneral disorders | 345/430 |
| COVID-19Infections and infestations | 79/430 |
| Injection site indurationGeneral disorders | 48/430 |
| PyrexiaGeneral disorders | 41/430 |
| HeadacheNervous system disorders | 41/430 |
| Injection site discomfortGeneral disorders | 38/430 |
| Back painMusculoskeletal and connective tissue disorders | 35/430 |
| Injection site noduleGeneral disorders | 32/430 |
| NasopharyngitisInfections and infestations | 30/430 |
| DiarrhoeaGastrointestinal disorders | 30/430 |
| Age, Continuous(Years) | Patient Study Participants |
|---|---|
| Mean | 44.2 ± 10.13 |
| Sex: Female, Male(Participants) | Patient Study Participants |
|---|---|
| Female | 115 |
| Male | 315 |
| Race/Ethnicity, Customized(Participants) | Patient Study Participants |
|---|---|
| American Indian Or Alaska Native | 7 |
| Asian | 9 |
| Black Or African American | 76 |
| White | 336 |
| Multiple | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Sep 2020 to primary completion in Mar 2022, 17 months.
Results were first posted in May 2023, 1 year 2 months after primary completion.
Of 70 industry-sponsored phase 3 interventional studies under HIV Infections, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 27. This study's 17 months is below that.
Counting every sponsor, half of 124 studies reached it within 25 months; a quarter within 18 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cabotegravir