HIV-1 InfectionPhase 4HOLANCT06185452

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

A Phase 4 study testing Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration and Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

HOLA is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase IV, double arm, open label, multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CAB+RPV, to evaluate the out-of-hospital… 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?: Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration and Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 9 sitesSpain
Study dates: 26 Sep 2023to 30 May 2025
Phase: Phase 4
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

Patients equal or older than 18 years old
Chronic HIV infection
HIV patients in whom LA CAB+RPV is prescribed
Recommended triple or dual therapy for at least 12 months, including CAB+RPV LA.
Virologically suppression for at least 6 months: 2 consecutive determinations of undetectable viral load (plasma HIV-1 RNA levels < 50 copies/ml ) for ≥ 6 months preceding the study randomization.
Post-menopausal or fertile females that agree to avoid pregnancy during the study. If sexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner) from 14 days prior to the first IMP administration until at least 13 months after the last Investigational Medicinal Product (IMP) administration;all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol.
Patients which have access to an out of hospital center in which can be treated without inconvenience
Patient who agrees to participate in the study and signs the informed consent.

Who cannot join

Hepatitis B infection (section 6.2).
History of virological failure or mutations to INSTI or NNRTI.
Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
Contraindication for intramuscular injections
Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future.
Current use of any concomitant treatment as indicated in section 5.6.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Spain9 sites

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

Other trials in Spain

About this study

Official title: Implementation of Out-of-HOspital Administration of the Long-Acting Combination Cabotegravir+Rilpivirine as an Optional Therapy in HIV-Infected Patients From Spain: Acceptability, Appropriateness, Feasibility and Satisfaction: The HOLA Study

Read the detailed description

Randomized patients will receive Long Acting (LA) cabotegravir (CAB) + rilpivirine (RPV) administration in the hospital (standard of care) or out-of-hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits, routinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12.

Conditions: HIV-1 Infection
Being tested: Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration, Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration
Keywords: HIV-1, long acting, primary center, community center, out-of-hospital by implementation, cabotegravir + rilpivirine (CAB+RPV)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administrationDrug
Also called Administration of LA CAB+RPV in the hospital
Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as standard of care.
Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administrationDrug
Also called Administration of LA CAB+RPV out of hospital
Out of Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as an optional therapy in HIV-Infected patients from Spain.

Study groups in NCT06185452
Study group	Role	What they receive
Hospital Group	Active comparator	Administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg in the hospital (standard of care) Receives: Drug: Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration
Outpatient Group	Experimental	Out-of-hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long -acting Rekambys (rilpivirine) 900 mg Receives: Drug: Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
Number of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires.
To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
Measured: at month 12
Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
Proportion of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires.
To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
Measured: at month 12
Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires.
To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
Measured: at month 12
Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
- Average composite score across the AIM questionnaires.
Measured: at month 12
Assess and compare the CAB + RPV LA - related adverse events (AEs) , all Serious Adverse Events (SAEs), injection site reactions (ISRs) or post injection reactions safety and tolerability of LA CAB+RPV (Safety and Tolerability)
Incidence and severity of CAB + RPV LA - related adverse events (AEs) , all Serious Adverse Events (SAEs), Injection site reactions (ISRs) or post injection reactions
Measured: through study completion, an average of 1 year
Assess and compare the safety and tolerability of LA CAB+RPV.
Proportion of participants who discontinue CAB + RPV LA due to AEs/SAEs
Measured: through study completion, an average of 1 year
Assess and compare the safety and tolerability of LA CAB+RPV.
Comparing between groups number and proportion of patients who withdraw treatment study due to antiretroviral-related adverse events and reasons
Measured: at month 6 and 12
Assess and compare the safety and tolerability of LA CAB+RPV.
Comparing between groups number and proportion of patients who presented grade 3 or 4 antiretroviral-related adverse events
Measured: at month 6 and 12

Secondary outcomes (30)

To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Number of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree) , as perceived by the patient. The higher score means the best outcome.
Measured: at month 1 and 6
To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree) , as perceived by the patient.The higher score means the best outcome.
Measured: at month 1 and 6
To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires
Measured: at month 1 and 6.
To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Average composite score across the AIM questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree) at month 1 and 6. The higher score means the best outcome.
Measured: at month 1 and 6
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Number of participants receiving injections with an average composite score ≥ 4 across the Intervention Appropriateness Measure( IAM) / Feasibility of Intervention Measure (FIM) questionnaires, (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree) as perceived by the patient. The higher score means the best outcome.
Measured: at months 1, 6 and 12
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Proportion of participants receiving injections with an average composite score ≥ 4 across the Intervention Appropriateness Measure( IAM) / Feasibility of Intervention Measure (FIM) questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree), as perceived by the patient.The higher score means the best outcome.
Measured: at months 1, 6 and 12
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the IAM /FIM questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree).The higher score means the best outcome.
Measured: at month 1, 6 and 12.
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Average composite score across the Intervention Appropriateness Measure (IAM) and Feasibility Intervention Measure (FIM) patient questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
Measured: at month 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by Healthcare Professionals (HCP)/non-clinical staff at study month 1 and month 6 and month 12.
Number of HCP and/or non- clinical staff that show an average composite score ≥ 4 across the Acceptability Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility Intervention Measure (FIM) patient questionnaires questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree).The higher score means the best outcome.
.
Measured: at months 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by Healthcare Professionals (HCP)/non-clinical staff at study month 1 and month 6 and month 12.
Proportion of HCP and/or non- clinical staff that show an average composite score ≥ 4 across the AIM / IAM /FIM questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree).The higher score means the best outcome.
.
Measured: at months 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by HCP/non-clinical staff at study month 1 and month 6 and month 12.
Differences among the proportion of HCP/non-clinical staff with an average composite score ≥ 4 across the AIM / IAM /FIM questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree).The higher score means the best outcome.
Measured: at month 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by HCP/non-clinical staff at study month 1 and month 6 and month 12.
Average composite score across the AIM / IAM /FIM questionnaires (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree).The higher score means the best outcome.
Measured: at month 1, 6 and 12.
Patient's satisfaction and expectations
To compare between groups the percentage of patients who report high satisfaction at each study time-points using the HIV Treatment Satisfaction Questionnaire (HIVTSQs12). This scale includes 11 items which are summed to form an 11-item scale score and one item, item 12 (pain/discomfort) is treated as an individual item score.
Measured: baseline and months 1, 6 and 12
Patient's satisfaction and expectations
To assess changes in satisfaction derived from HIV Treatment Satisfaction Questionnaire status (HIVTSQs12), in the overall sample.
Measured: from baseline to months 1, 6 and 12
Patient's satisfaction and expectations
To assess changes in satisfaction derived from HIV Treatment Satisfaction Questionnaire change (HIVTSQc12) in the overall sample.
Measured: from baseline to month 12
Patient's satisfaction and expectations
To assess and compare among groups the expectations of the LA CAB+RPV regarding the following areas: adherence to treatment, follow-up of medical visits, illness perception, physical and emotional quality of life, family and social relationships and work. Expectations will be assessed through 5-likert scales developed ad hoc for the study
Measured: at baseline and month 6 and 12
Patient's satisfaction and expectations
To compare among groups the Patient Reported Outcome Measures (PROMs) at each study time-points using the Patient Reported Outcome Measures HIV Clinic Screening Tool (PROMS-CST- HIV) questionnaire. This questionnaire assesses PRO regarding anticipated stigma, emotional distress, sexuality, social support, material deprivation, sleep and fatigue, cognitive problems, physical symptoms.
Measured: baseline and months 1, 6 and 12
Patient's satisfaction and expectations
To assess changes in the Patient Reported Outcome Measures (PROMs) throughout the time points in each group in the overall sample using the Patient Reported Outcome Measures HIV Clinic Screening Tool (PROMS-CST- HIV) questionnaire. This questionnaire assesses PRO regarding anticipated stigma, emotional distress, sexuality, social support, material deprivation, sleep and fatigue, cognitive problems, physical symptoms.
Measured: from baseline to months 1, 6 and 12
Patient's satisfaction and expectations
To compare changes in the health professionals 'expectations using a Health Professional Expectations Questionnaire.
Measured: through study completion, an average of 1 year
Patient's satisfaction and expectations
To compare the perception of injection, using the perception of injection (PIN) questionnaire.
Measured: month 1, 2,4,6,8,10 and month 12.
Retention, engagement and compliance
To compare among groups number of patients who miss their appointment for the LA CAB+RPV administration (out of the window period ±7 days)
Measured: from baseline to month 6 and 12
Retention, engagement and compliance
To compare among groups proportion of patients who miss their appointment for the LA CAB+RPV administration (out of the window period ±7 days)
Measured: from baseline to month 6 and 12
Retention, engagement and compliance
To compare among groups number of patients who early interrupt LA CAB+RPV every 2 months
Measured: at month 6 and 12.
Retention, engagement and compliance
To compare among groups proportion of patients who early interrupt LA CAB+RPV every 2 months
Measured: at month 6 and 12.
Retention, engagement and compliance
To compare among groups number of patients who withdraw treatment study
Measured: at month 6 and 12.
Retention, engagement and compliance
To compare among groups proportion of patients who withdraw treatment study
Measured: at month 6 and 12.
Retention, engagement and compliance
Time to LA CAB + RPV discontinuation.
Measured: through study completion, an average of 1 year
Retention, engagement and compliance
To compare among groups the number of patients who adopt oral bridging therapy
Measured: during the 12 months of study.
Retention, engagement and compliance
To compare among groups the proportion of patients who adopt oral bridging therapy
Measured: during the 12 months of study.
To identify those patients in which the out-of-hospital administration is more suitable.
To identify those patients in which the out-of-hospital administration is more suitable by comparing the previous endpoints, stratifying according to: age (< vs >50 years old), gender (male vs female), as well as according to if the participant is already receiving or not LA CAB+RPV.
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 202330 May 2025

First posted29 Dec 2023
Study start26 Sep 2023
Primary completion30 May 2025
Study completion30 May 2025

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A 12-months prospective, hybrid type (implementation-effectiveness), phase IV, randomized (1:1), open label, multicentric study.
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06185452
Sponsor's protocol ID: Out-of-hospital LA CAB+RPV
Acronym: HOLA
Status last verified: Jul 2025
First submitted: 22 Sep 2023
Last updated: 14 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Processed study data will be in the EU CT Register DB access code 2023-503963-41-00. The raw and personal data protected by privacy laws. After publishing results, the raw dataset that supports the findings of this study are available from sponsor, but data restricted by license, not publicly available. Raw datasets results are, however, available for other researchers from the authors upon reasonable request for collaborative analyses and with the permission of sponsor. Investigators must show the proposed use of the data has been approved by an independent review committee identified for this purpose, and proposal is methodologically sound. Data sharing subject to the regulations (The Organic Law 3/2018 of 5 December on the Protection of Personal Data and the Guarantee of Digital Rights complementary to the Regulation (EU) 2016/679 of 27 April 2016, on protecting individuals regarding processing personal data and free movement).

Publications

Negredo E, Hernandez-Sanchez D, Alvarez-Lopez P, Falco V, Rivero A, Jusmet J, Cuerda Palomo MA, Flores de la Cruz AB, Pavon JM, Llavero N, Campany D, Faus V, Broto-Cortes C, Bailon L, Aguilar D, Ruiz F, Miranda C, Puig J, Rovira D, Olalla J. Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA study)-a hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study: study protocol. BMJ Open. 2025 Apr 10;15(4):e088514. doi: 10.1136/bmjopen-2024-088514.
PubMed 40216420

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Out-of-HOspital Administration of the Long-Acting Combination Cabotegravir+Rilpivirine as an Optional Therapy in HIV-Infected Patients From Spain: Acceptability, Appropriateness, Feasibility and Satisfaction: The HOLA Study
ClinicalTrials.gov ID: NCT06185452
Acronym / sponsor ID: HOLA / Out-of-hospital LA CAB+RPV
Conditions: HIV-1 Infection
Keywords: HIV-1, long acting, primary center, community center, out-of-hospital by implementation, cabotegravir + rilpivirine (CAB+RPV)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 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: 26 Sep 2023 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 30 May 2025 (actual)
First posted: 29 Dec 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A 12-months prospective, hybrid type (implementation-effectiveness), phase IV, randomized (1:1), open label, multicentric study.

Arm	Type	Receives
Hospital Group	Active comparator	Drug: Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administrationAdministration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg in the hospital (standard of care)
Outpatient Group	Experimental	Drug: Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administrationOut-of-hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long -acting Rekambys (rilpivirine) 900 mg

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients equal or older than 18 years old
Chronic HIV infection
HIV patients in whom LA CAB+RPV is prescribed
Recommended triple or dual therapy for at least 12 months, including CAB+RPV LA.
Virologically suppression for at least 6 months: 2 consecutive determinations of undetectable viral load (plasma HIV-1 RNA levels < 50 copies/ml ) for ≥ 6 months preceding the study randomization.

Key exclusion criteria (6 listed)

Hepatitis B infection (section 6.2).
History of virological failure or mutations to INSTI or NNRTI.
Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
Contraindication for intramuscular injections
Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future.

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
Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administrationAlso: Administration of LA CAB+RPV in the hospitalHospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as standard of care.	Drug	Hospital Group
Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administrationAlso: Administration of LA CAB+RPV out of hospitalOut of Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as an optional therapy in HIV-Infected patients from Spain.	Drug	Outpatient Group

Primary outcome

Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
Time frame: at month 12
Number of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires. To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
Time frame: at month 12
Proportion of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires. To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
Time frame: at month 12
Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires. To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome.
Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections.
Time frame: at month 12
To asses the acceptability we will use the Acceptability Intervention Measure (AIM) questionnaire (item questionnaires that use a 5-point rating scale: 1 = completely disagree to 5 = completely agree). The higher score means the best outcome. - Average composite score across the AIM questionnaires.
Assess and compare the CAB + RPV LA - related adverse events (AEs) , all Serious Adverse Events (SAEs), injection site reactions (ISRs) or post injection reactions safety and tolerability of LA CAB+RPV (Safety and Tolerability)
Time frame: through study completion, an average of 1 year
Incidence and severity of CAB + RPV LA - related adverse events (AEs) , all Serious Adverse Events (SAEs), Injection site reactions (ISRs) or post injection reactions
Assess and compare the safety and tolerability of LA CAB+RPV.
Time frame: through study completion, an average of 1 year
Proportion of participants who discontinue CAB + RPV LA due to AEs/SAEs
Assess and compare the safety and tolerability of LA CAB+RPV.
Time frame: at month 6 and 12
Comparing between groups number and proportion of patients who withdraw treatment study due to antiretroviral-related adverse events and reasons
Assess and compare the safety and tolerability of LA CAB+RPV.
Time frame: at month 6 and 12
Comparing between groups number and proportion of patients who presented grade 3 or 4 antiretroviral-related adverse events

30 secondary outcomes

To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Time frame: at month 1 and 6
To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Time frame: at month 1 and 6
To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Time frame: at month 1 and 6.
To assess and compare the acceptability of the administration of LA CAB + RPV as perceived by patients at intermediate times of the study (month 1 and month 6).
Time frame: at month 1 and 6
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Time frame: at months 1, 6 and 12
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Time frame: at months 1, 6 and 12
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Time frame: at month 1, 6 and 12.
To assess and compare appropriateness and feasibility of the administration of LA CAB + RPV as perceived by patients at month 1, month 6 and month 12.
Time frame: at month 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by Healthcare Professionals (HCP)/non-clinical staff at study month 1 and month 6 and month 12.
Time frame: at months 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by Healthcare Professionals (HCP)/non-clinical staff at study month 1 and month 6 and month 12.
Time frame: at months 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by HCP/non-clinical staff at study month 1 and month 6 and month 12.
Time frame: at month 1, 6 and 12.
To assess and compare the acceptability, appropriateness and feasibility of the administration of LA CAB + RPV as perceived by HCP/non-clinical staff at study month 1 and month 6 and month 12.
Time frame: at month 1, 6 and 12.
Patient's satisfaction and expectations
Time frame: baseline and months 1, 6 and 12
Patient's satisfaction and expectations
Time frame: from baseline to months 1, 6 and 12
Patient's satisfaction and expectations
Time frame: from baseline to month 12
Patient's satisfaction and expectations
Time frame: at baseline and month 6 and 12
Patient's satisfaction and expectations
Time frame: baseline and months 1, 6 and 12
Patient's satisfaction and expectations
Time frame: from baseline to months 1, 6 and 12
Patient's satisfaction and expectations
Time frame: through study completion, an average of 1 year
Patient's satisfaction and expectations
Time frame: month 1, 2,4,6,8,10 and month 12.
Retention, engagement and compliance
Time frame: from baseline to month 6 and 12
Retention, engagement and compliance
Time frame: from baseline to month 6 and 12
Retention, engagement and compliance
Time frame: at month 6 and 12.
Retention, engagement and compliance
Time frame: at month 6 and 12.
Retention, engagement and compliance
Time frame: at month 6 and 12.
Retention, engagement and compliance
Time frame: at month 6 and 12.
Retention, engagement and compliance
Time frame: through study completion, an average of 1 year
Retention, engagement and compliance
Time frame: during the 12 months of study.
Retention, engagement and compliance
Time frame: during the 12 months of study.
To identify those patients in which the out-of-hospital administration is more suitable.
Time frame: through study completion, an average of 1 year

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 14 Jul 2025.
Derived from this study: PubMed 40216420Negredo E, Hernandez-Sanchez D, Alvarez-Lopez P, Falco V, Rivero A, Jusmet J, Cuerda Palomo MA, Flores de la Cruz AB, Pavon JM, Llavero N, Campany D, Faus V, Broto-Cortes C, Bailon L, Aguilar D, Ruiz F, Miranda C, Puig J, Rovira D, Olalla J. Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA study)-a hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study: study protocol. BMJ Open. 2025 Apr 10;15(4):e088514. doi: 10.1136/bmjopen-2024-088514.
Individual participant dataSharing planned: Yes. Processed study data will be in the EU CT Register DB access code 2023-503963-41-00. The raw and personal data protected by privacy laws. After publishing results, the raw dataset that supports the findings of this study are available from sponsor, but data restricted by license, not publicly available. Raw datasets results are, however, available for other researchers from the authors upon reasonable request for collaborative analyses and with the permission of sponsor. Investigators must show the proposed use of the data has been approved by an independent review committee identified for this purpose, and proposal is methodologically sound. Data sharing subject to the regulations (The Organic Law 3/2018 of 5 December on the Protection of Personal Data and the Guarantee of Digital Rights complementary to the Regulation (EU) 2016/679 of 27 April 2016, on protecting individuals regarding processing personal data and free movement).

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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?

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 8 inclusion and 6 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 14 Jul 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Evaluate the acceptability of the administration of LA CAB + RPV in Alternative Injection Facilities (AOF) from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections. (time frame: at month 12). The study lists 8 primary outcomes in all. 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 NCT06185452, 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 14 Jul 2025.