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AzTrials

HIV InfectionsPhase 3NCT04399551

A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

A Phase 3 study testing CAB OLI, CAB LA and RPV OLI in people with HIV Infections, run by ViiV Healthcare at 18 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
CAB OLI, CAB LA and RPV OLI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
437 participants
Where
18 sitesin 5 countries
Study dates
28 Sep 2020to 13 Mar 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants aged 18 years or older at the time of signing the informed consent.
  • HIV-1 infected and must be suppressed on a guideline recommended active Highly active antiretroviral therapy (HAART) regimen for at least 6 months prior to screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for virologic failure (on treatment HIV-1 RNA more than or equal to [>=]200 c/mL).
  • Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: at least one <6 months prior to screening and one 6-12 months prior to screening.
  • Plasma HIV-1 RNA <50 c/mL at screening.
  • 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:
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  • Pre-menopausal females with one of the following:
  • Documented tubal ligation.
  • Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion.
  • Hysterectomy.
  • Documented Bilateral Oophorectomy.
  • Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
  • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written informed consent form before any protocol-specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
  • French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Within 6 months prior to screening, plasma HIV-1 RNA measurement >=50 c/mL.
  • During the previous 12 months, any confirmed HIV-1 RNA measurement >=200 c/mL.
  • Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study.
  • Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy, and historical or current Cluster of Differentiation 4 (CD4)+ counts <200 cells per millimeter cube (cells/mm^3) are not exclusionary.
  • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
  • Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the investigator believes the risk of seizure recurrence is low.
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  • Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
  • The participant has a tattoo, gluteal implant/ enhancements or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
  • 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 positive for HBsAg are excluded.
  • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
  • Participants who are anticipated to require Hepatitis C virus (HCV) treatment within 12 months must be excluded. Asymptomatic individuals with chronic HCV infection will not be excluded; investigators must carefully assess if therapy specific for HCV infection is required. (HCV treatment on study may be permitted, following consultation and approval of the DAA based therapy being considered with the medical monitor).
  • Participants with HCV co-infection will be allowed entry into this study if:
  • Liver enzymes meet entry criteria.
  • HCV disease has undergone appropriate work-up, and is not advanced. Additional information (where available) on participants with HCV coinfection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
  • In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility:
  • Fib-4 score more than (>)3.25 is exclusionary.
  • Fib-4 score 1.45-3.25 requires Medical Monitor consultation Fibrosis 4 score formula:
  • (Age times Aspartate aminotransferase [AST]) / (Platelets times (square [Alanine aminotransferase]{ALT}).
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • History of liver cirrhosis with or without hepatitis viral co-infection.
  • Ongoing or clinically relevant pancreatitis.
  • Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to inclusion.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
  • History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 mg per day) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease
  • Any evidence of primary resistance based on the presence of any major known Integrase inhibitor (INI) or Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation, except for K103N, by any historical resistance test result.
  • ALT >=5 times the upper limit of normal (ULN) or ALT >=3 times ULN and bilirubin >=1.5 times ULN (with >35 percent [%] direct bilirubin).
  • Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.
  • Participant has estimated creatinine clearance <50 milliliters per minute (mL/min)/1.73 m^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.
  • Treatment with any of the following agents within 28 days of Day 1:
  • Radiation therapy.
  • Cytotoxic chemotherapeutic agents.
  • Tuberculosis therapy except for isoniazid (isonicotinylhydrazid [INH]).
  • Anti-coagulation agents.
  • Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
  • Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility.
  • Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
  • A participant with known or suspected active Coronavirus Disease 2019 (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment (World Health Organization [WHO] definitions).

Trial locations and contacts

18 sites in 5 countries.

18 sites in 5 countries

France6 sites

  • GSK Investigational Site

    Bordeaux, 33075

  • GSK Investigational Site

    Orléans, 45067

  • GSK Investigational Site

    Paris, 75004

  • GSK Investigational Site

    Paris, 75010

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Belgium4 sites

  • GSK Investigational Site

    Antwerp, 2000

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Ghent, 9000

Other trials in Belgium

Spain4 sites

  • GSK Investigational Site

    Alicante, 03010

  • GSK Investigational Site

    Cartagena (Murcia), 30202

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Germany2 sites

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Munich, Bavaria, 80337

Other trials in Germany

Netherlands2 sites

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: A Phase IIIb, Open-label, Hybrid Type III Trial Evaluating Implementation Strategies for Long-acting Cabotegravir Plus Long-acting Rilpivirine Every Two Months in HIV-1 Infected, Virologically Suppressed Adults in Select European Healthcare Settings

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.

Conditions
HIV Infections
Being tested
CAB OLI, CAB LA, RPV OLI, RPV LA, Continuous Quality Improvement (CQI) calls
Keywords
Cabotegravir, Rilpivirine, Long-acting injectables, Patient study participants, Staff study participants
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAB OLIDrug

    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 LADrug

    CAB LA 600 mg will be administered as intramuscular (IM) injection.

  • RPV OLIDrug

    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 LADrug

    RPV LA 900 mg will be administered as IM injection.

  • Continuous Quality Improvement (CQI) callsOther

    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.

Study groups in NCT04399551
Study groupRoleWhat they receive
Participants with HIV infectionExperimentalHIV-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.
Receives: Drug: CAB OLI; Drug: CAB LA; Drug: RPV OLI; Drug: RPV LA
Staff study participants (SSP)OtherStaff 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).
Receives: Other: Continuous Quality Improvement (CQI) calls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Month 1) and Month 12

  2. 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.

    Measured: Baseline (Month 1) and Month 12

  3. 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.

    Measured: Baseline (Month 1) and Month 12

  4. 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.

    Measured: Up to 12 Months

  5. 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.

    Measured: Up to Month 12

  6. 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.

    Measured: Up to Month 12

Secondary outcomes (43)

  1. 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.

    Measured: Up to 12 Months

  2. 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.

    Measured: Up to 12 Months

  3. 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.

    Measured: Up to 12 Months

  4. 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.

    Measured: Up to 12 Months

  5. 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.

    Measured: Up to 12 Months

  6. 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.

    Measured: Up to 12 Months

  7. 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.

    Measured: Baseline (Month 1) and Month 12

  8. 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.

    Measured: Month 1 and Month 12

  9. 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.

    Measured: Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

  10. 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.

    Measured: Month 2 to Month 7

  11. 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.

    Measured: Up to Month 12

  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.

    Measured: Month 12

  13. 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.

    Measured: Month 12

  14. 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.

    Measured: Month 12

  15. 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.

    Measured: Month 12

  16. 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.

    Measured: Month 12

  17. 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.

    Measured: Month 12

  18. 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.

    Measured: Month 12

  19. 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.

    Measured: Month 12

  20. 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.

    Measured: Month 12

  21. 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.

    Measured: Month 12

  22. 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.

    Measured: Month 12

  23. 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.

    Measured: Month 12

  24. 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.

    Measured: Month 12

  25. 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.

    Measured: Month 12

  26. 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.

    Measured: Month 12

  27. 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.

    Measured: Month 12

  28. 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.

    Measured: Up to Month 12

  29. 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.

    Measured: Up to Month 12

  30. 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.

    Measured: Up to Month 12

  31. 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.

    Measured: Up to Month 12

  32. 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.

    Measured: Up to Month 12

  33. 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.

    Measured: Up to Month 12

  34. 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.

    Measured: Baseline (Month 1) and Month 12

  35. 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.

    Measured: Baseline (Month 1) and Month 12

  36. 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.

    Measured: Baseline (Month 1) and Month 12

  37. 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.

    Measured: Month 12

  38. Percentage of PSP Receiving Injections Within Target Window

    The target window for participants to receive injection was from Day -7 to Day 7.

    Measured: Day -7 to Day 7 of Month 2, 4, 6, 8, 10 and 12

  39. 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.

    Measured: Month 1, 2, 4, 8 and 12

  40. 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.

    Measured: Month 1, 2, 4, 8, 10 and 12

  41. 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.

    Measured: Up to 12 Months

  42. 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.

    Measured: Up to 12 Months

  43. 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.

    Measured: Up to 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start28 Sep 2020
  3. Primary completion7 Mar 2022
  4. Study completion13 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399551
Sponsor's protocol ID
213199
Status last verified
Apr 2024
First submitted
18 May 2020
Last updated
5 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Jonsson-Oldenbuttel C, Ghosn J, van der Valk M, Florence E, Vera F, De Wit S, Rami A, Bonnet F, Hocqueloux L, Hove K, Ait-Khaled M, DeMoor R, Bontempo G, Latham CL, Gutner CA, Iyer S, Gill M, Czarnogorski M, D'Amico R, van Wyk J. Safety and Effectiveness From the Cabotegravir and Rilpivirine Implementation Study in European Locations Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings. J Acquir Immune Defic Syndr. 2024 Aug 15;96(5):472-480. doi: 10.1097/QAI.0000000000003448. Epub 2024 Jul 9.

    PubMed 38985445

  • Gutner CA, Hocqueloux L, Jonsson-Oldenbuttel C, Vandekerckhove L, van Welzen BJ, Slama L, Crusells-Canales M, Sierra JO, DeMoor R, Scherzer J, Ait-Khaled M, Bontempo G, Gill M, Patel N, D'Amico R, Hove K, Baugh B, Barnes N, Hadi M, Low EL, Anand SB, Hamilton A, Garges HP, Czarnogorski M. Implementation of long-acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations. J Int AIDS Soc. 2024 Jul;27(7):e26243. doi: 10.1002/jia2.26243.

    PubMed 38978405

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CAB OLI, CAB LA and RPV OLI in people with HIV Infections, run by ViiV Healthcare at 18 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 41 exclusion criteria. 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: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Belgium, Spain, Germany, Netherlands. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 (time frame: Baseline (Month 1) and Month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04399551, which also lists 2 linked publications.

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 5 Apr 2024.

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