Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
- Conditions
- HIV-1 Infection
- Interventions
- Drug: Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administrationDrug: Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration
- Registration Number
- NCT06185452
- Lead Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hospital Group Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration Administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg in the hospital (standard of care) Outpatient Group Out 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
- Primary Outcome Measures
Name Time Method 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 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) 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. at month 6 and 12 Comparing between groups number and proportion of patients who presented grade 3 or 4 antiretroviral-related adverse events
- Secondary Outcome Measures
Name Time Method 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 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.
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 month 1, 6 and 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.
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. 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.
.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. 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.
Patient's satisfaction and expectations month 1, 2,4,6,8,10 and month 12. To compare the perception of injection, using the perception of injection (PIN) questionnaire.
Retention, engagement and compliance during the 12 months of study. To compare among groups the proportion of patients who adopt oral bridging therapy
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.
Trial Locations
- Locations (9)
Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron
🇪🇸Barcelona, Spain
BCN CheckPoint
🇪🇸Barcelona, Spain
Cs Leganitos
🇪🇸Málaga, Spain
Germans Trias I Pujol Hospital
🇪🇸Badalona, Barcelona, Spain
Cs San Luis de Sabinillas
🇪🇸San Luis de Sabinillas, Málaga, Spain
Hospital Costa Del Sol
🇪🇸Málaga, Malaga, Spain
CAP Dr ROBERT
🇪🇸Barcelona, Spain
Hospital Vall D' Hebrón
🇪🇸Barcelona, Spain
Cs San Pedro de Alcántara
🇪🇸Málaga, Spain