Skip to main content
OpenTrials
Completed

NCT Number: NCT06185452

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1 Infection

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Germans Trias I Pujol Hospital, Badalona, BARCELONA, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Administration of LA CAB+RPV in the hospital

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.

Other names: Administration of LA CAB+RPV out of hospital

Primary outcomes

  1. 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.

    Time frame: at month 12

    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.

  2. 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.

    Time frame: at month 12

    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.

  3. 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.

    Time frame: at month 12

    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.

  4. 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.

    Time frame: 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.

  5. 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)

    Time frame: 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

  6. Assess and compare the safety and tolerability of LA CAB+RPV.

    Time frame: through study completion, an average of 1 year

    Proportion of participants who discontinue CAB + RPV LA due to AEs/SAEs

  7. Assess and compare the safety and tolerability of LA CAB+RPV.

    Time frame: at month 6 and 12

    Comparing between groups number and proportion of patients who withdraw treatment study due to antiretroviral-related adverse events and reasons

  8. Assess and compare the safety and tolerability of LA CAB+RPV.

    Time frame: at month 6 and 12

    Comparing between groups number and proportion of patients who presented grade 3 or 4 antiretroviral-related adverse events

Secondary outcomes

  1. 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).

    Time frame: at month 1 and 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.

  2. 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).

    Time frame: at month 1 and 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.

  3. 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).

    Time frame: at month 1 and 6.

    Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires

  4. 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).

    Time frame: 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.

  5. 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.

    Time frame: at months 1, 6 and 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.

  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.

    Time frame: at months 1, 6 and 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.

  7. 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.

    Time frame: at month 1, 6 and 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.

  8. 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.

    Time frame: 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.

  9. 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.

    Time frame: at months 1, 6 and 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.

    .

  10. 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.

    Time frame: 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.

    .

  11. 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.

    Time frame: at month 1, 6 and 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.

  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.

    Time frame: 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.

  13. Patient's satisfaction and expectations

    Time frame: baseline and months 1, 6 and 12

    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.

  14. Patient's satisfaction and expectations

    Time frame: from baseline to months 1, 6 and 12

    To assess changes in satisfaction derived from HIV Treatment Satisfaction Questionnaire status (HIVTSQs12), in the overall sample.

  15. Patient's satisfaction and expectations

    Time frame: from baseline to month 12

    To assess changes in satisfaction derived from HIV Treatment Satisfaction Questionnaire change (HIVTSQc12) in the overall sample.

  16. Patient's satisfaction and expectations

    Time frame: at baseline and month 6 and 12

    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

  17. Patient's satisfaction and expectations

    Time frame: baseline and months 1, 6 and 12

    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.

  18. Patient's satisfaction and expectations

    Time frame: from baseline to months 1, 6 and 12

    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.

  19. Patient's satisfaction and expectations

    Time frame: through study completion, an average of 1 year

    To compare changes in the health professionals 'expectations using a Health Professional Expectations Questionnaire.

  20. Patient's satisfaction and expectations

    Time frame: month 1, 2,4,6,8,10 and month 12.

    To compare the perception of injection, using the perception of injection (PIN) questionnaire.

  21. Retention, engagement and compliance

    Time frame: from baseline to month 6 and 12

    To compare among groups number of patients who miss their appointment for the LA CAB+RPV administration (out of the window period ±7 days)

  22. Retention, engagement and compliance

    Time frame: from baseline to month 6 and 12

    To compare among groups proportion of patients who miss their appointment for the LA CAB+RPV administration (out of the window period ±7 days)

  23. Retention, engagement and compliance

    Time frame: at month 6 and 12.

    To compare among groups number of patients who early interrupt LA CAB+RPV every 2 months

  24. Retention, engagement and compliance

    Time frame: at month 6 and 12.

    To compare among groups proportion of patients who early interrupt LA CAB+RPV every 2 months

  25. Retention, engagement and compliance

    Time frame: at month 6 and 12.

    To compare among groups number of patients who withdraw treatment study

  26. Retention, engagement and compliance

    Time frame: at month 6 and 12.

    To compare among groups proportion of patients who withdraw treatment study

  27. Retention, engagement and compliance

    Time frame: through study completion, an average of 1 year

    Time to LA CAB + RPV discontinuation.

  28. Retention, engagement and compliance

    Time frame: during the 12 months of study.

    To compare among groups the number of patients who adopt oral bridging therapy

  29. Retention, engagement and compliance

    Time frame: during the 12 months of study.

    To compare among groups the proportion of patients who adopt oral bridging therapy

  30. To identify those patients in which the out-of-hospital administration is more suitable.

    Time frame: 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.

Other outcomes

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

    Time frame: at month 6 and 12.

    Proportion of subjects who are virologically suppressed (plasma HIV-1 RNA ≤ 50 copies/mL)

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

    Time frame: at month 6 and 12.

    Proportion of participants with confirmed virologic failure/rebound (2 consecutive HIV-1 RNA greater than or equal to 200 c/mL)

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

    Time frame: at month 12

    Proportion of participants with blips

  4. 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.

    Time frame: from baseline to month 12.

    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.

  5. 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.

    Time frame: from baseline to month 12.

    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.

  6. 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.

    Time frame: at month 12

    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.

  7. 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.

    Time frame: baseline and month 1, 6 and 12

    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.

  8. 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.

    Time frame: from baseline to month 1, 6 and 12.

    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.

  9. 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.

    Time frame: from baseline to month 12

    To assess and compare changes in satisfaction derived from HIVTSQc12.

  10. 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.

    Time frame: at baseline and months 6 and 12

    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.

  11. 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.

    Time frame: baseline and months 1, 6 and 12

    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.

  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.

    Time frame: from baseline to months 1, 6 and 12.

    To assess and compare changes in the PROMs throughout the time points in each group.

  13. 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.

    Time frame: at month 12.

    Difference in number and proportion of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires.

  14. 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.

    Time frame: at month 12.

    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.

  15. 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.

    Time frame: baseline and month 1, 6 and 12

    To compare between groups the percentage of patients who report high satisfaction at each study time-points using the HIVTSQs12.

  16. 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.

    Time frame: from baseline to month 1, 6 and 12.

    To assess changes in satisfaction derived from HIVTSQs12 .

  17. 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.

    Time frame: from baseline to month 12

    To assess changes in satisfaction derived from HIVTSQc12

  18. 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.

    Time frame: at baseline and months 6 and 12

    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..

  19. 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.

    Time frame: baseline and months 1, 6 and 12

    To compare among groups the PROMs at each study time-points using the PROMS-CST-HIV questionnaire.

  20. 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.

    Time frame: from baseline to months 1, 6 and 12

    To assess changes in the PROMs throughout the time points in each group.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: HOLA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2023
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.