Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CAB OLI · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Participants with HIV infection | EXPERIMENTAL | 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. |
| Staff study participants (SSP) | OTHER | 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). |
| Name | Type | Description |
|---|---|---|
| CAB OLI | DRUG | 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 | DRUG | CAB LA 600 mg will be administered as intramuscular (IM) injection. |
| RPV OLI | DRUG | 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 | DRUG | RPV LA 900 mg will be administered as IM injection. |
| Continuous Quality Improvement (CQI) calls | OTHER | 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. |
Inclusion Criteria: * 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 a...
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CAB OLI is an investigational small molecule being studied for the treatment of HIV infections. It is currently in Phase 3 clinical development. The drug is being evaluated as part of a long-acting injectable regimen for HIV-1 treatment, with a completed clinical trial assessing implementation strategies in European countries.
CAB OLI is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's use in treating HIV infections, with the most recent study focused on implementation strategies for long-acting injectable therapy in Europe.
CAB OLI is in Phase 3 clinical development for the treatment of HIV infections. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation for potential use in HIV-1 treatment.
CAB OLI has one completed Phase 3 clinical trial registered under NCT04399551. This study evaluated implementation strategies for cabotegravir plus rilpivirine long-acting injectables for HIV-1 treatment in European countries, enrolling 437 participants across Belgium, France, Germany, Netherlands, and Spain.
CAB OLI is a small molecule that targets HIV infection. It is designed to be used in combination with rilpivirine as a long-acting injectable regimen for HIV-1 treatment. The drug works by interfering with the HIV virus's ability to replicate, helping to control the infection in patients.
CAB OLI is the drug name used in the clinical trial for cabotegravir, an investigational HIV treatment. The study NCT04399551 evaluates cabotegravir (CAB) plus rilpivirine (RPV) as long-acting injectables for HIV-1 treatment. The drug is being developed by GSK plc and is currently in Phase 3 development.