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

Not Applicable

Completed

• Conditions: HIV-1-infection

• Registration Number: NCT06643897
• Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

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.

Study Timeline

• Study Start: 2024-07-16
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-16
• Primary Completion: 2024-10-23
• Study Completion: 2024-10-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

CAP Dr Robert; 🇪🇸 Barcelona, Spain

Hospital Vall D' Hebrón; 🇪🇸 Barcelona, Spain

Germans Trias I Pujol Hospital; 🇪🇸 Badalona, Barcelona, Spain

Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron; 🇪🇸 Barcelona, Spain

BCN CheckPoint; 🇪🇸 Barcelona, Spain

Cs Leganitos; 🇪🇸 Málaga, Spain

Hospital Costa Del Sol; 🇪🇸 Málaga, Spain

Cs San Luis de Sabinillas; 🇪🇸 Málaga, Spain

Cs San Pedro de Alcántara; 🇪🇸 Málaga, Spain