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

NCT ID: NCT06643897

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2024-10-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1-infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Qualitative Interview

All study staff who participate in the substudy will be interviewed through a 40-50 minute-qualitative interview.

Group Type OTHER

Qualitative Interview

Intervention Type OTHER

40-50 minute-qualitative interview.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Qualitative Interview

40-50 minute-qualitative interview.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Germans Trias I Pujol Hospital

Badalona, Barcelona, Spain

Site Status

CAP Dr Robert

Barcelona, , Spain

Site Status

Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron

Barcelona, , Spain

Site Status

BCN CheckPoint

Barcelona, , Spain

Site Status

Hospital Vall D' Hebrón

Barcelona, , Spain

Site Status

Cs Leganitos

Málaga, , Spain

Site Status

Hospital Costa Del Sol

Málaga, , Spain

Site Status

Cs San Luis de Sabinillas

Málaga, , Spain

Site Status

Cs San Pedro de Alcántara

Málaga, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Hernandez-Sanchez D, Leyva-Moral JM, Olalla J, Negredo E, On Behalf Of The Hola Study Group. Barriers and Facilitators of Implementation of the Non-Hospital-Based Administration of Long-Acting Cabotegravir Plus Rilpivirine in People with HIV: Qualitative Data from the HOLA Study. Viruses. 2025 Jul 16;17(7):993. doi: 10.3390/v17070993.

Reference Type DERIVED
PMID: 40733609 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Substudy LA CAB+RPV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.