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.

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Other: Qualitative Interview

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d' Hebron
  • Barcelona, Spain, 08015
    • BCN CheckPoint
  • Barcelona, Spain, 08001
    • CAP Dr ROBERT
  • Barcelona, Spain, 08001
    • Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron
  • Málaga, Spain, 29603
    • Hospital Costa Del Sol
  • Málaga, Spain, 29601
    • Cs Leganitos
  • Málaga, Spain, 29692
    • Cs San Pedro de Alcántara
  • Málaga, Spain, 29692
    • Cs San Luis de Sabinillas
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Germans Trias i Pujol Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Qualitative Interview; All study staff who participate in the substudy will be interviewed through a 40-50 minute-qualitative interview.	Other: Qualitative Interview; 40-50 minute-qualitative interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	after the first 6 months of participation in the study

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: HIV-1; long acting; interview; barriers and facilitators; out-of-hospital by implementation; cabotegravir + rilpivirine (CAB+RPV)
• Other Study ID Numbers: Substudy LA CAB+RPV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No