Clinical trial NCT06185452: Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HIV-1 Infection
Keywords: HIV-1
long acting
primary center
community center
out-of-hospital by implementation
cabotegravir + rilpivirine (CAB+RPV)
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 12-months prospective, hybrid type (implementation-effectiveness), phase IV, randomized (1:1), open label, multicentric study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: at month 12
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.
timeFrame: at month 12
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.
timeFrame: at month 12
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.
timeFrame: at month 12
measure: 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)
timeFrame: through study completion, an average of 1 year
measure: Assess and compare the safety and tolerability of LA CAB+RPV.
timeFrame: through study completion, an average of 1 year
measure: Assess and compare the safety and tolerability of LA CAB+RPV.
timeFrame: at month 6 and 12
measure: Assess and compare the safety and tolerability of LA CAB+RPV.
timeFrame: at month 6 and 12
Secondary outcomes:
measure: 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).
timeFrame: at month 1 and 6
measure: 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).
timeFrame: at month 1 and 6
measure: 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).
timeFrame: at month 1 and 6.
measure: 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).
timeFrame: at month 1 and 6
measure: 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.
timeFrame: at months 1, 6 and 12
measure: 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.
timeFrame: at months 1, 6 and 12
measure: 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.
timeFrame: at month 1, 6 and 12.
measure: 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.
timeFrame: at month 1, 6 and 12.
measure: 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.
timeFrame: at months 1, 6 and 12.
measure: 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.
timeFrame: at months 1, 6 and 12.
measure: 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.
timeFrame: at month 1, 6 and 12.
measure: 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.
timeFrame: at month 1, 6 and 12.
measure: Patient's satisfaction and expectations
timeFrame: baseline and months 1, 6 and 12
measure: Patient's satisfaction and expectations
timeFrame: from baseline to months 1, 6 and 12
measure: Patient's satisfaction and expectations
timeFrame: from baseline to month 12
measure: Patient's satisfaction and expectations
timeFrame: at baseline and month 6 and 12
measure: Patient's satisfaction and expectations
timeFrame: baseline and months 1, 6 and 12
measure: Patient's satisfaction and expectations
timeFrame: from baseline to months 1, 6 and 12
measure: Patient's satisfaction and expectations
timeFrame: through study completion, an average of 1 year
measure: Patient's satisfaction and expectations
timeFrame: month 1, 2,4,6,8,10 and month 12.
measure: Retention, engagement and compliance
timeFrame: from baseline to month 6 and 12
measure: Retention, engagement and compliance
timeFrame: from baseline to month 6 and 12
measure: Retention, engagement and compliance
timeFrame: at month 6 and 12.
measure: Retention, engagement and compliance
timeFrame: at month 6 and 12.
measure: Retention, engagement and compliance
timeFrame: at month 6 and 12.
measure: Retention, engagement and compliance
timeFrame: at month 6 and 12.
measure: Retention, engagement and compliance
timeFrame: through study completion, an average of 1 year
measure: Retention, engagement and compliance
timeFrame: during the 12 months of study.
measure: Retention, engagement and compliance
timeFrame: during the 12 months of study.
measure: To identify those patients in which the out-of-hospital administration is more suitable.
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: To assess and compare between groups the virological effectiveness of CAB + RPV LA
timeFrame: at month 6 and 12.
measure: To assess and compare between groups the virological effectiveness of CAB + RPV LA
timeFrame: at month 6 and 12.
measure: To assess and compare between groups the virological effectiveness of CAB + RPV LA
timeFrame: at month 12
measure: 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.
timeFrame: from baseline to month 12.
measure: 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.
timeFrame: from baseline to month 12.
measure: 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.
timeFrame: at month 12
measure: 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.
timeFrame: baseline and month 1, 6 and 12
measure: 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.
timeFrame: from baseline to month 1, 6 and 12.
measure: 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.
timeFrame: from baseline to month 12
measure: 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.
timeFrame: at baseline and months 6 and 12
measure: 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.
timeFrame: baseline and months 1, 6 and 12
measure: 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.
timeFrame: from baseline to months 1, 6 and 12.
measure: 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.
timeFrame: at month 12.
measure: 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.
timeFrame: at month 12.
measure: 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.
timeFrame: baseline and month 1, 6 and 12
measure: 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.
timeFrame: from baseline to month 1, 6 and 12.
measure: 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.
timeFrame: from baseline to month 12
measure: 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.
timeFrame: at baseline and months 6 and 12
measure: 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.
timeFrame: baseline and months 1, 6 and 12
measure: 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.
timeFrame: from baseline to months 1, 6 and 12
Locations:
city: Badalona
country: Spain
facility: Germans Trias I Pujol Hospital
state: Barcelona
city: Málaga
country: Spain
facility: Hospital Costa Del Sol
state: Malaga
city: San Luis de Sabinillas
country: Spain
facility: Cs San Luis de Sabinillas
state: Málaga
city: Barcelona
country: Spain
facility: CAP Dr ROBERT
city: Barcelona
country: Spain
facility: Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron
city: Barcelona
country: Spain
facility: BCN CheckPoint
city: Barcelona
country: Spain
facility: Hospital Vall D' Hebrón
city: Málaga
country: Spain
facility: Cs Leganitos
city: Málaga
country: Spain
facility: Cs San Pedro de Alcántara
Study officials:
References: