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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06185452

Acronym

HOLA

Enrollment

103

Registered

2023-12-29

Start date

2023-09-26

Completion date

2025-05-30

Last updated

2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection

Keywords

HIV-1, long acting, primary center, community center, out-of-hospital by implementation, cabotegravir + rilpivirine (CAB+RPV)

Brief 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 administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.

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.

Interventions

DRUGHospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration

Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as standard of care.

DRUGOut of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A 12-months prospective, hybrid type (implementation-effectiveness), phase IV, randomized (1:1), open label, multicentric study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Patients equal or older than 18 years old 2. Chronic HIV infection 3. HIV patients in whom LA CAB+RPV is prescribed 4. Recommended triple or dual therapy for at least 12 months, including CAB+RPV LA. 5. 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. 6. 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. 7. Patients which have access to an out of hospital center in which can be treated without inconvenience 8. Patient who agrees to participate in the study and signs the informed consent.

Exclusion criteria

1. Hepatitis B infection (section 6.2). 2. History of virological failure or mutations to INSTI or NNRTI. 3. Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month. 4. Contraindication for intramuscular injections 5. Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future. 6. Current use of any concomitant treatment as indicated in section 5.6.

Design outcomes

Primary

Measure	Time frame	Description
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)	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.	through study completion, an average of 1 year	Proportion of participants who discontinue CAB + RPV LA due to AEs/SAEs
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.	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.

Secondary

Measure	Time frame	Description
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.	at months 1, 6 and 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. .
Patient's satisfaction and expectations	baseline and months 1, 6 and 12	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.
Retention, engagement and compliance	from baseline to month 6 and 12	To compare among groups number of patients who miss their appointment for the LA CAB+RPV administration (out of the window period ±7 days)
To identify those patients in which the out-of-hospital administration is more suitable.	through study completion, an average of 1 year	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.
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.	at month 1, 6 and 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.
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).	at month 1 and 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.
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.	at months 1, 6 and 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.

Other

Measure	Time frame	Description
To assess and compare between groups the virological effectiveness of CAB + RPV LA	at month 6 and 12.	Proportion of subjects who are virologically suppressed (plasma HIV-1 RNA ≤ 50 copies/mL)
To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV and those patients who have never received LA CAB+RPV.	at month 12.	Difference in number and proportion of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires.
To compare the average change at month 12 vs baseline in patient's acceptability, satisfaction and expectations among the subgroup of participants with previous experience with LA CAB + RPV.	from baseline to month 12.	Difference in number of participants receiving injections that show 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).The higher score means the best outcome.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026