Trial · NCT04399551
A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
NCT04399551, Phase 3, Completed, ViiV Healthcare; results first posted 2023-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries. Trials, record NCT04399551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04399551
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
- NCT number
- NCT04399551
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 437 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- HIV Infections
- Interventions
- CAB OLI, CAB LA, RPV OLI, RPV LA, Continuous Quality Improvement (CQI) calls
- First posted
- 2020-05-22
- Last updated
- 2024-04-05
- Results first posted
- 2023-05-19
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Baseline (Month 1) and 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. |
| Primary | Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Baseline (Month 1) and 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. |
| Primary | Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Baseline (Month 1) and 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. |
| Primary | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Up to 12 Months | 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. |
| Primary | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | Up to Month 12 | 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. |
| Primary | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Up to Month 12 | 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. |
| Secondary | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Up to 12 Months | 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. |
| Secondary | Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs | Up to 12 Months | 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. |
| Secondary | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Up to 12 Months | 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. |
| Secondary | Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs | Up to 12 Months | 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. |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Baseline (Month 1) and Month 12 | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Scores on a scale | MEAN |
| PRIMARY | Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Baseline (Month 1) and Month 12 | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Scores on a scale | MEAN |
| PRIMARY | Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Baseline (Month 1) and Month 12 | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Up to 12 Months | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs | Up to 12 Months | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Up to 12 Months | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs | Up to 12 Months | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Up to 12 Months | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs | Up to 12 Months | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 | Baseline (Month 1) and Month 12 | Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed. | Scores on a scale | MEAN |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group404
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Staff Study Participants - Enhanced Implementation Arm | Baseline (Month 1) | 3.8 | Standard Deviation 0.76 | Scores on a scale |
| Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Staff Study Participants - Standard Implementation Arm | Baseline (Month 1) | 3.9 | Standard Deviation 0.75 | Scores on a scale |
| Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Staff Study Participants - Enhanced Implementation Arm | Month 12 | 0.28 | Standard Deviation 0.828 | Scores on a scale |
| Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Staff Study Participants - Standard Implementation Arm | Month 12 | 0.33 | Standard Deviation 0.666 | Scores on a scale |
| Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Staff Study Participants-Enhanced Implementation Arm | Baseline (Month 1) | 3.8 | Standard Deviation 0.78 | Scores on a scale |
| Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Staff Study Participants - Standard Implementation Arm | Baseline (Month 1) | 3.9 | Standard Deviation 0.78 | Scores on a scale |
| Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Staff Study Participants-Enhanced Implementation Arm | Month 12 | 0.22 | Standard Deviation 0.740 | Scores on a scale |
| Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Staff Study Participants - Standard Implementation Arm | Month 12 | 0.31 | Standard Deviation 0.729 | Scores on a scale |
| Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Staff Study Participants - Enhanced Implementation Arm | Baseline (Month 1) | 4.0 | Standard Deviation 0.66 | Scores on a scale |
| Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Staff Study Participants - Standard Implementation Arm | Baseline (Month 1) | 4.0 | Standard Deviation 0.64 | Scores on a scale |
1 to 10 of 404Source ClinicalTrials.gov
See all 404 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patient Study Participants | 430 | |
| Overall Study | COMPLETED | Patient Study Participants | 402 | |
| Overall Study | NOT COMPLETED | Patient Study Participants | 28 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | Patient Study Participants | 345 | 430 | 1,632 |
| other | Injection site induration | General disorders | Patient Study Participants | 48 | 430 | 79 |
| other | Injection site discomfort | General disorders | Patient Study Participants | 38 | 430 | 94 |
| other | Pyrexia | General disorders | Patient Study Participants | 41 | 430 | 54 |
| other | Injection site nodule | General disorders | Patient Study Participants | 32 | 430 | 57 |
| other | Injection site swelling | General disorders | Patient Study Participants | 27 | 430 | 38 |
| other | Asthenia | General disorders | Patient Study Participants | 27 | 430 | 32 |
| other | COVID-19 | Infections and infestations | Patient Study Participants | 79 | 430 | 85 |
| other | Nasopharyngitis | Infections and infestations | Patient Study Participants | 30 | 430 | 33 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Patient Study Participants | 35 | 430 | 36 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patient Study Participants | 0 | 430 |
| Total, other adverse events | Patient Study Participants | 384 | 430 |
| Total, serious adverse events | Patient Study Participants | 17 | 430 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Staff Study Participants - Standard Implementation Arm vs Staff Study Participants - Enhanced Implementation Arm: Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs | Trial comparisons |
Staff Study Participants - Standard Implementation Arm vs Staff Study Participants - Enhanced Implementation Arm: Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs | Trial comparisons |
Staff Study Participants - Standard Implementation Arm vs Staff Study Participants - Enhanced Implementation Arm: Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04399551
GET https://conductscience.org/api/trials/v1/NCT04399551/registered?page=2