HIV-1-infectionNCT06643897
Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.
A study testing Qualitative Interview in people with HIV-1-infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 9 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Qualitative Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 9 sitesSpain
- Study dates
- 16 Jul 2024to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation throughout the HOLA study until the moment of conducting the interviews and direct involvement in the study procedures in a significant way.
- Homogeneous sample between the different roles participating in the study.
- Participants who agree to participate in the substudy and sign the informed consent.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Germans Trias I Pujol Hospital
Badalona, Barcelona, 08916
CAP Dr Robert
Barcelona, 08001
Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron
Barcelona, 08001
BCN CheckPoint
Barcelona, 08015
Hospital Vall D' Hebrón
Barcelona, 08035
Cs Leganitos
Málaga, 29601
Hospital Costa Del Sol
Málaga, 29603
Cs San Luis de Sabinillas
Málaga, 29692
Cs San Pedro de Alcántara
Málaga, 29692
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- Qualitative Interview
- Keywords
- barriers and facilitators, interview, long acting, out-of-hospital by implementation, cabotegravir + rilpivirine (CAB+RPV), HIV-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewOther
40-50 minute-qualitative interview.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Interview | Other | All study staff who participate in the substudy will be interviewed through a 40-50 minute-qualitative interview. Receives: Other: Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: after the first 6 months of participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start16 Jul 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643897
- Sponsor's protocol ID
- Substudy LA CAB+RPV
- Status last verified
- Jan 2025
- First submitted
- 8 Oct 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40733609
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06643897
- Acronym / sponsor ID
- Substudy LA CAB+RPV
- Conditions
- HIV-1-infection
- Keywords
- barriers and facilitators, interview, long acting, out-of-hospital by implementation, cabotegravir + rilpivirine (CAB+RPV), HIV-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interview | Other | Other: Qualitative InterviewAll study staff who participate in the substudy will be interviewed through a 40-50 minute-qualitative interview. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation throughout the HOLA study until the moment of conducting the interviews and direct involvement in the study procedures in a significant way.
- Homogeneous sample between the different roles participating in the study.
- Participants who agree to participate in the substudy and sign the informed consent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative Interview40-50 minute-qualitative interview. | Other | Qualitative Interview |
Primary outcome
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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 40733609Hernandez-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.
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Interview in people with HIV-1-infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: after the first 6 months of participation in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06643897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.