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

HIV-1 Infection Clinical Trial

— HOLA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185452
• Other study ID #: Out-of-hospital LA CAB+RPV
• Status: Recruiting
• Phase: Phase 4
• Start date: September 26, 2023
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

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.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• Hospital 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.
• 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 as an optional therapy in HIV-Infected patients from Spain.

Locations

Country	Name	City	State
Spain	Germans Trias I Pujol Hospital	Badalona	Barcelona
Spain	BCN CheckPoint	Barcelona
Spain	CAP Dr ROBERT	Barcelona
Spain	Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron	Barcelona
Spain	Hospital Vall D' Hebrón	Barcelona
Spain	Cs Leganitos	Málaga
Spain	Cs San Pedro de Alcántara	Málaga
Spain	Hospital Costa Del Sol	Málaga	Malaga
Spain	Cs San Luis de Sabinillas	San Luis de Sabinillas	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess and compare between groups the virological effectiveness of CAB + RPV LA	Proportion of subjects who are virologically suppressed (plasma HIV-1 RNA < 50 copies/mL)	at month 6 and 12.
Other	To assess and compare between groups the virological effectiveness of CAB + RPV LA	Proportion of participants with confirmed virologic failure/rebound (2 consecutive HIV-1 RNA greater than or equal to 50 c/mL)	at month 6 and 12.
Other	To assess and compare between groups the virological effectiveness of CAB + RPV LA	Proportion of participants with blips	at month 12
Other	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 in the context of a clinical trial	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.	from baseline to month 12.
Other	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 in the context of a clinical trial	Difference in proportion 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.	from baseline to month 12.
Other	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 in the context of a clinical trial	Average composite score across the Acceptability of Intervention Measure (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.	at month 12
Other	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 in the context of a clinical trial	To compare between both groups the percentage of patients who report high satisfaction at each study time-points using the 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.	baseline and month 1, 6 and 12
Other	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 in the context of a clinical trial	To assess and compare changes in satisfaction derived from HIV Treatment Satisfaction Questionnaire status (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.	from baseline to month 1, 6 and 12.
Other	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 in the context of a clinical trial	To assess and compare changes in satisfaction derived from HIVTSQc12.	from baseline to month 12
Other	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 in the context of a clinical trial	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.	at baseline and months 6 and 12
Other	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 in the context of a clinical trial	To compare among groups the Patient Reported Outcome Measures (PROMs) at each study time-points using the 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.	baseline and months 1, 6 and 12
Other	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 in the context of a clinical trial	To assess and compare changes in the PROMs throughout the time points in each group.	from baseline to months 1, 6 and 12.
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	Difference in number and proportion of participants receiving injections that show an average composite score = 4 across the AIM questionnaires.	at month 12.
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	Difference in the average composite score across the Acceptability of Intervention Measure questionnaires (AIM) (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.
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	To compare between groups the percentage of patients who report high satisfaction at each study time-points using the HIVTSQs12.	baseline and month 1, 6 and 12
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	To assess changes in satisfaction derived from HIVTSQs12 .	from baseline to month 1, 6 and 12.
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	To assess changes in satisfaction derived from HIVTSQc12	from baseline to month 12
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	To assess and compare among groups the expectations of the LA CAB+RPV regarding the following areas: adherence to treatment, followup 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..	at baseline and months 6 and 12
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	To compare among groups the PROMs at each study time-points using the PROMS-CST-HIV questionnaire.	baseline and months 1, 6 and 12
Other	To compare patient's acceptability, satisfaction and expectations between patients under prior treatment with LA CAB+RPV in the context of a clinical trial and those patients who have never received LA CAB+RPV.	To assess changes in the PROMs throughout the time points in each group.	from baseline to months 1, 6 and 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	at month 1 and 6
Secondary	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.	at month 1 and 6
Secondary	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	at month 1 and 6.
Secondary	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.	at month 1 and 6
Secondary	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.	at months 1, 6 and 12
Secondary	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.	at months 1, 6 and 12
Secondary	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.	at month 1, 6 and 12.
Secondary	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.	at month 1, 6 and 12.
Secondary	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.; .	at months 1, 6 and 12.
Secondary	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.; .	at months 1, 6 and 12.
Secondary	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.	at month 1, 6 and 12.
Secondary	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.	at month 1, 6 and 12.
Secondary	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.	baseline and months 1, 6 and 12
Secondary	Patient's satisfaction and expectations	To assess changes in satisfaction derived from HIV Treatment Satisfaction Questionnaire status (HIVTSQs12), in the overall sample.	from baseline to months 1, 6 and 12
Secondary	Patient's satisfaction and expectations	To assess changes in satisfaction derived from HIV Treatment Satisfaction Questionnaire change (HIVTSQc12) in the overall sample.	from baseline to month 12
Secondary	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	at baseline and month 6 and 12
Secondary	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.	baseline and months 1, 6 and 12
Secondary	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.	from baseline to months 1, 6 and 12
Secondary	Patient's satisfaction and expectations	To compare changes in the health professionals 'expectations using a Health Professional Expectations Questionnaire.	through study completion, an average of 1 year
Secondary	Patient's satisfaction and expectations	To compare the perception of injection, using the perception of injection (PIN) questionnaire.	month 1, 2,4,6,8,10 and month 12.
Secondary	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)	from baseline to month 6 and 12
Secondary	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)	from baseline to month 6 and 12
Secondary	Retention, engagement and compliance	To compare among groups number of patients who early interrupt LA CAB+RPV every 2 months	at month 6 and 12.
Secondary	Retention, engagement and compliance	To compare among groups proportion of patients who early interrupt LA CAB+RPV every 2 months	at month 6 and 12.
Secondary	Retention, engagement and compliance	To compare among groups number of patients who withdraw treatment study	at month 6 and 12.
Secondary	Retention, engagement and compliance	To compare among groups proportion of patients who withdraw treatment study	at month 6 and 12.
Secondary	Retention, engagement and compliance	Time to LA CAB + RPV discontinuation.	through study completion, an average of 1 year
Secondary	Retention, engagement and compliance	To compare among groups the number of patients who adopt oral bridging therapy	during the 12 months of study.
Secondary	Retention, engagement and compliance	To compare among groups the proportion of patients who adopt oral bridging therapy	during the 12 months of study.
Secondary	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.	through study completion, an average of 1 year