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Report for Clinical Trial NCT04399551

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

CAB LA + RPV LA is an investigational HIV-1 treatment regimen administered as two individual intramuscular injections every 2 months following an oral lead-in (OLI) period. 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 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. Standard arm represents the traditional provider support by a medical science lead and product materials. Enhanced arm models a higher level of provider support with added face to face meeting, trainings, and additional touchpoints for administration of CAB LA + RPV LA. The study will evaluate both qualitative and quantitative measures across arm, clinic type, provider type and country to determine the most effective implementation strategies and to identify barriers and facilitators (including solutions). Approximately 450 participants will be enrolled in this study and the total duration of the study will be around 12 months.

NCT04399551 HIV Infections
MeSH:HIV Infections

5 Interventions

Name: CAB OLI

Description: CAB will be available as 30 mg tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
Type: Drug
Group Labels: 1

Participants with HIV infection

Name: CAB LA

Description: CAB LA 600 mg will be administered as intramuscular (IM) injection.
Type: Drug
Group Labels: 1

Participants with HIV infection

Name: RPV OLI

Description: 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.
Type: Drug
Group Labels: 1

Participants with HIV infection

Name: RPV LA

Description: RPV LA 600 mg will be administered as intramuscular (IM) injection.
Type: Drug
Group Labels: 1

Participants with HIV infection

Name: Continuous Quality Improvement (CQI) calls

Description: 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.
Type: Other
Group Labels: 1

Staff study participants (SSP)


Primary Outcomes

Description: The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in the acceptability of implementation measure (AIM) score in SSP based on Likert scale

Time: Baseline and up to 12 months

Description: The responses for appropriateness will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in the implementation appropriateness measure (IAM) score in SSP based on Likert scale

Time: Baseline and up to 12 months

Description: The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in the feasibility of implementation measure (FIM) score in SSP based on Likert scale

Time: Baseline and up to 12 months

Description: Acceptability will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for acceptability using SSI in SSP

Time: Baseline and up to 12 months

Description: Appropriateness will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for appropriateness using SSI in SSP

Time: Baseline and up to 12 months

Description: Feasibility will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for feasibility using SSI in SSP

Time: Baseline and up to 12 months

Secondary Outcomes

Description: Implementation Leadership will be assessed through brief self-report measures rated on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in the Implementation Leadership Scale (ILS) in SSP based on Likert scale

Time: Baseline and up to 12 months

Description: Implementation Climate will be assessed through brief self-report measures rated on a 2-point Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in the Implementation climate scale (ICS) in SSP based on Likert scale

Time: Baseline and up to 12 months

Description: The FRAME-IS is a measure that will be completed monthly to provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.

Measure: Change from Baseline in Frame-IS outcome in SSP

Time: Baseline and up to 12 months

Description: The CQI calls will start by helping identify problems/challenges, generate plans to address the challenges, and identify how to measure the change that results from the plan, so that at each call, staff study participants can discuss progress with the CQI leader and get support if are needed. CQI will be attended by enhanced arm. During each call, study staff participants will be asked to identify barriers to implementing CAB LA + RPV LA that they identify and work.

Measure: Number of SSP participating in CQI calls

Time: Up to 12 months

Description: Facilitators will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for facilitators using SSI in SSP

Time: Baseline and up to 12 months

Description: Barriers will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview

Measure: Change from Baseline in theme for barriers using SSI in SSP

Time: Baseline and up to 12 months

Description: Facilitators from the participant's perspective will be evaluated by the usefulness of the patient specific toolkit resources.

Measure: Change from Baseline in the use of patient specific toolkit resources to evaluate facilitators in PSP

Time: Baseline and up to 12 months

Description: Barriers from the participant's perspective will be evaluated by the usefulness of the patient specific toolkit resources.

Measure: Change from Baseline in the use of patient specific toolkit resources to evaluate barriers in PSP

Time: Baseline and up to 12 months

Description: Facilitators effecting time spent in appointments to receive injections will be assessed.

Measure: Facilitators to CAB LA + RPV LA in PSP

Time: Up to 12 months

Description: Barriers effecting time spent in appointments to receive injections will be assessed.

Measure: Barriers to CAB LA + RPV LA in PSP

Time: Up to 12 months

Description: Length of study visit from arrival until departure from clinic will be evaluated. Time of arrival, time of appointment, and departure times will be recorded in the electronic case report form (eCRF).

Measure: Length of PSP visit

Time: Up to 12 months

Description: Facilitators will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for facilitators using SSI in PSP

Time: Baseline and up to 12 months

Description: Barriers will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for barriers using SSI in PSP

Time: Baseline and up to 12 months

Description: The responses for acceptability will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in acceptability of intervention measure (AIM) score in PSP

Time: Baseline and up to 12 months

Description: The responses for appropriateness will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in Intervention appropriateness measure (IAM) score in PSP

Time: Baseline and up to 12 months

Description: The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in Feasibility of intervention measure (FIM) score in PSP

Time: Baseline and up to 12 months

Description: Acceptability will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for acceptability using SSI in PSP

Time: Baseline and up to 12 months

Description: Appropriateness will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for appropriateness using SSI in PSP

Time: Baseline and up to 12 months

Description: Feasibility will be assessed as part of theme emerging from EPIS framework guided semi-structured qualitative interview.

Measure: Change from Baseline in theme for feasibility using SSI in PSP

Time: Baseline and up to 12 months

Description: The CSAT will evaluate the capability of clinics to maintain processes developed to administer CAB LA+RPV LA injections in routine clinical settings after the conclusion of this study.

Measure: Sustainability assessed in SSP using Clinical sustainability assessment tool (CSAT)

Time: Up to 12 months

Description: Fidelity will be assessed to CAB LA + RPV LA injection dosing windows.

Measure: Percentage of participants in PSP receiving injections within target window

Time: Up to 12 months

Description: Plasma samples will be collected from the participant at specific time points.

Measure: Percentage of participants in PSP with plasma HIV-1 Ribonucleic acid (RNA) <50 copies per milliliter (c/mL)

Time: Up to 12 months

Description: CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL

Measure: Percentage of participants in PSP with confirmed virologic failure (CVF)

Time: Up to 12 months

Description: Blood samples will be collected and used for the analysis of genotypic resistance in participants with CVF.

Measure: Number of participants in PSP with treatment-emergent genotypic resistance to CAB

Time: Up to 12 months

Description: Blood samples will be collected and used for the analysis of genotypic resistance in participants with CVF.

Measure: Number of participants in PSP with treatment-emergent genotypic resistance to RPV

Time: Up to 12 months

Description: Blood samples will be collected and used for the analysis of phenotypic resistance in participants with CVF.

Measure: Number of participants in PSP with treatment-emergent phenotypic resistance to CAB

Time: Up to 12 months

Description: Blood samples will be collected and used for the analysis of phenotypic resistance in participants with CVF.

Measure: Number of participants in PSP with treatment-emergent phenotypic resistance to RPV

Time: Up to 12 months

Description: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. Severity of AE/ SAE will be included.

Measure: Number of participants in PSP with adverse events (AEs) and serious AEs (SAEs)

Time: Up to 12 months

Description: An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who will discontinue the treatment due to AEs will be reported. Percentage of participants discontinuing treatment due to AEs will be assessed.

Measure: Percentage of participants in PSP discontinuing treatment due to AEs

Time: Up to 12 months

Description: PSP preference of CAB + RPV LA over daily oral ART medication will be assessed using preference questionnaire.

Measure: Number of participants in PSP preferring CAB + RPV LA over daily oral antiretroviral therapy (ART) medication

Time: Up to 12 months

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 K103N

Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (<=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. --- K103N ---



HPO Nodes