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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Outpatient Group | Experimental | Out-of-hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long -acting Rekambys (rilpivirine) 900 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| To assess and compare between groups the virological effectiveness of CAB + RPV LA |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias I Pujol Hospital | Badalona | BARCELONA | 08916 | Spain | ||
| CAP Dr ROBERT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40216420 | Derived | 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. |
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Processed study data will be in the EU CT Register DB access code 2023-503963-41-00. The raw and personal data protected by privacy laws. After publishing results, the raw dataset that supports the findings of this study are available from sponsor, but data restricted by license, not publicly available. Raw datasets results are, however, available for other researchers from the authors upon reasonable request for collaborative analyses and with the permission of sponsor. Investigators must show the proposed use of the data has been approved by an independent review committee identified for this purpose, and proposal is methodologically sound. Data sharing subject to the regulations (The Organic Law 3/2018 of 5 December on the Protection of Personal Data and the Guarantee of Digital Rights complementary to the Regulation (EU) 2016/679 of 27 April 2016, on protecting individuals regarding processing personal data and free movement).
Final data exportation is scheduled for June 2025 and statistical analyses will follow, with complete datasets expected for the first quarter of 2026.
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
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A 12-months prospective, hybrid type (implementation-effectiveness), phase IV, randomized (1:1), open label, multicentric study.
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|
| 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. |
|
|
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 |
| 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). | 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| Retention, engagement and compliance | To compare among groups number of patients who withdraw treatment study | at month 6 and 12. |
| Retention, engagement and compliance | To compare among groups proportion of patients who withdraw treatment study | at month 6 and 12. |
| Retention, engagement and compliance | Time to LA CAB + RPV discontinuation. | through study completion, an average of 1 year |
| Retention, engagement and compliance | To compare among groups the number of patients who adopt oral bridging therapy | during the 12 months of study. |
| Retention, engagement and compliance | To compare among groups the proportion of patients who adopt oral bridging therapy | during the 12 months of study. |
| 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 |
Proportion of participants with confirmed virologic failure/rebound (2 consecutive HIV-1 RNA greater than or equal to 200 c/mL) |
| at month 6 and 12. |
| To assess and compare between groups the virological effectiveness of CAB + RPV LA | Proportion of participants with blips | at month 12 |
| 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. | 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. |
| 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. | 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. |
| 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. | 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 |
| 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. | 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 |
| 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. | 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. |
| 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. | To assess and compare changes in satisfaction derived from HIVTSQc12. | from baseline to month 12 |
| 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. | 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 |
| 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. | 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 |
| 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. | To assess and compare changes in the PROMs throughout the time points in each group. | from baseline to months 1, 6 and 12. |
| 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. | Difference in number and proportion of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires. | at month 12. |
| 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. | 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. |
| 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. | 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 |
| 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. | To assess changes in satisfaction derived from HIVTSQs12 . | from baseline to month 1, 6 and 12. |
| 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. | To assess changes in satisfaction derived from HIVTSQc12 | from baseline to month 12 |
| 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. | 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 |
| 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. | To compare among groups the PROMs at each study time-points using the PROMS-CST-HIV questionnaire. | baseline and months 1, 6 and 12 |
| 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. | To assess changes in the PROMs throughout the time points in each group. | from baseline to months 1, 6 and 12 |
| Barcelona |
| Barcelona |
| 08001 |
| Spain |
| Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron | Barcelona | Barcelona | 08001 | Spain |
| BCN CheckPoint | Barcelona | Barcelona | 08015 | Spain |
| Hospital Vall D' Hebrón | Barcelona | Barcelona | 08035 | Spain |
| Hospital Costa Del Sol | Málaga | Malaga | 29603 | Spain |
| Cs Leganitos | Málaga | Málaga | 29601 | Spain |
| Cs San Pedro de Alcántara | Málaga | Málaga | 29692 | Spain |
| Cs San Luis de Sabinillas | San Luis de Sabinillas | Málaga | 29692 | Spain |
| ID | Term |
|---|---|
| C584914 | cabotegravir |
| D000068696 | Rilpivirine |
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006298 | Health Services Administration |
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