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

NCT06185452 | Completed Phase 4

• 1 other identifier: Out-of-hospital LA CAB+RPV
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 9

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.

Conditions

HIV-1 Infection

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  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).

  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).

  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).

  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).

  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.

  at months 1, 6 and 12

Other Outcomes (20)

• To assess and compare between groups the virological effectiveness of CAB + RPV LA

  at month 6 and 12.

• To assess and compare between groups the virological effectiveness of CAB + RPV LA

  at month 6 and 12.

• To assess and compare between groups the virological effectiveness of CAB + RPV LA

  at month 12

Study Arms (2)

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)

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

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

Interventions

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

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

Also known as: Administration of LA CAB+RPV in the hospital

Hospital Group

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

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.

Also known as: Administration of LA CAB+RPV out of hospital

Outpatient Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

Germans Trias I Pujol Hospital

Badalona, BARCELONA, 08916, Spain

Location

CAP Dr ROBERT

Barcelona, Barcelona, 08001, Spain

Location

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

Barcelona, Barcelona, 08001, Spain

Location

BCN CheckPoint

Barcelona, Barcelona, 08015, Spain

Location

Hospital Vall D' Hebrón

Barcelona, Barcelona, 08035, Spain

Location

Hospital Costa Del Sol

Málaga, Malaga, 29603, Spain

Location

Cs Leganitos

Málaga, Málaga, 29601, Spain

Location

Cs San Pedro de Alcántara

Málaga, Málaga, 29692, Spain

Location

Cs San Luis de Sabinillas

San Luis de Sabinillas, Málaga, 29692, Spain

Location

Related Publications (1)

• 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.

  PMID: 40216420 DERIVED

MeSH Terms

Interventions

cabotegravir; Rilpivirine; Organization and Administration

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: December 29, 2023
• Study Start: September 26, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Final data exportation is scheduled for June 2025 and statistical analyses will follow, with complete datasets expected for the first quarter of 2026.
• Access Criteria: Investigators must prove that the proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, and the proposal is methodologically sound. Data sharing is subject to the regulations aforementioned

Locations

ES (9)