Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.

Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina as an Optional Therapy in People Living With HIV From Spain.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06643897

Enrollment

Registered

2024-10-16

Start date

2024-07-16

Completion date

2024-10-23

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

Keywords

barriers and facilitators, interview, long acting, out-of-hospital by implementation, cabotegravir + rilpivirine (CAB+RPV), HIV-1

Brief summary

The study will identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the study.

Detailed description

This substudy will use a qualitative descriptive approach based on Consolidated Framework for Implementation Research (CFIR). Data will be collected using semi-structured interviews among HOLA staff participants until achieving data saturation. Data will be analyzed using Braun & Clarke's thematic analysis method.

Interventions

OTHERQualitative Interview

40-50 minute-qualitative interview.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

The substudy is a transversal, one arm, multicentric study including the staff participating in the HOLA study, to identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA following a qualitative descriptive design. All study staff who participate in the substudy will be interviewed through a 40-50 minute-qualitative interview

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Participation throughout the HOLA study until the moment of conducting the interviews and direct involvement in the study procedures in a significant way. 2. Homogeneous sample between the different roles participating in the study. 3. Participants who agree to participate in the substudy and sign the informed consent.

Exclusion criteria

NONE

Design outcomes

Primary

Measure	Time frame	Description
Identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the study.	after the first 6 months of participation in the study	1\. To assess barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the HOLA study, at any time after the first 6 months of participation in the study. These will be assessed through a 40-50 minute-qualitative interview created for the study, which references the following domains: adaptability to the intervention, consideration of the needs of patients, changes in infrastructure, implementation climate (need of change, compatibility), preparation for implementation (leadership engagement and resource availability), individual characteristics, need for external agents, main stakeholders, execution and final considerations.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026