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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration; Drug: Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08015
    • Recruiting
    • BCN CheckPoint
    • Contact: Angel Rivero Calaf, MD,PhD; Phone Number: 93 318 20 56; Email: arivero@lluita.org
    • Principal Investigator: Angel Rivero Calaf, MdPhD
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Vall d' Hebron
    • Contact: Vicenç Falco Ferrer, MD,PhD; Phone Number: 93 274 60 90; Email: vicenc.falco@vallhebron.cat
    • Principal Investigator: Vicenç Falco Ferrer, MD,PhD
  • Barcelona, Spain, 08001
    • Recruiting
    • CAP Dr ROBERT
    • Contact: Javier Jusmat Miguel, MD,PhD; Phone Number: 933 84 24 25; Email: jjusmet.mn.ics@gencat.cat
    • Principal Investigator: Javier Jusmet Miguel, MD,PhD
  • Barcelona, Spain, 08001
    • Recruiting
    • Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron
    • Contact: Patricia Álvarez López, MD,PhD; Phone Number: 93 489 44 08; Email: patricia.alvarez@vallhebron.cat
    • Principal Investigator: Patricia Álvarez López, MD,PhD
  • Málaga, Spain, 29601
    • Recruiting
    • Cs Leganitos
    • Contact: José Manuel Pavón Mata, MD,PhD; Phone Number: 951 97 33 74; Email: jmpavon76@gmail.com
    • Principal Investigator: José Manuel Pavón Mata, MD,PhD
  • Málaga, Spain, 29692
    • Recruiting
    • Cs San Pedro de Alcántara
    • Contact: Ana Belén Flores de la Cruz, MD,PhD; Phone Number: 951 97 34 36; Email: anab_fc@hotmail.com
    • Principal Investigator: Ana Belén Flores de la Cruz, MD,PhD
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Germans Trias I Pujol Hospital
      • Contact: EUGÈNIA NEGREDO PUIGMAL, MD,PhD; Phone Number: 93 497 84 14; Email: enegredo@lluita.org
      • Principal Investigator: EUGÈNIA NEGREDO PUIGMAL, MD,PhD
  • Malaga
    • Málaga, Malaga, Spain, 29603
      • Recruiting
      • Hospital Costa del Sol
      • Contact: Julian Olalla Sierra, MD,PhD; Phone Number: 951 97 66 69; Email: julio.olalla@gmail.com
      • Principal Investigator: Julián Olalla Sierra, MD,PhD
  • Málaga
    • San Luis de Sabinillas, Málaga, Spain, 29692
      • Recruiting
      • Cs San Luis de Sabinillas
      • Contact: Miguel Angel Cuerda Palomo, MD,PhD; Phone Number: 951 27 06 48; Email: mangel.cuerda.sspa@juntadeandalucia.es
      • Principal Investigator: Miguel Angel Cuerda Palomo, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hospital Group; Administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg in the hospital (standard of care)	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.; Other Names: Administration of LA CAB+RPV in the hospital
Experimental: Outpatient Group; Out-of-hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long -acting Rekambys (rilpivirine) 900 mg	Drug: 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.; Other Names: Administration of LA CAB+RPV out of hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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.
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 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.
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.
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
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
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.
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
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
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
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.
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.
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.
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
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.
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HIV-1; long acting; primary center; community center; out-of-hospital by implementation; cabotegravir + rilpivirine (CAB+RPV)
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Rilpivirine; Cabotegravir
• Other Study ID Numbers: Out-of-hospital LA CAB+RPV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No