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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C, Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

5 Oct 2023 → 30 May 2025

Decision date (initial)

2023-08-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ViiV Healthcare

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The study will evaluate: 1. the acceptability at month 12 of the administration of LA CAB + RPV in AOF from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections. 2. will also assess and compare the safety and tolerability of the LA CAB+RPV.

Secondary objectives 6

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).
2. 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.
3. 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.
4. Patient’s satisfaction and expectations: -To assess and compare patient’s satisfaction - To assess and compare 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. -To assess and compare the Patient Reported Outcome Measures (PROMs). -To assess changes in the PROMs in the overall sample. -To assess and compare changes in the health professionals’ expectations. -To compare the perception of injection (PIN).
5. Retention, engagement and compliance: -To assess and compare the patients who lose their appointment for the LA CAB+RPV administration. -To assess and compare the patients who early interrupt LA CAB+RPV. -To compare among groups the number and proportion of patients who adopt oral bridging therapy during the 12 months of study.
6. To identify those patients in which the out-of-hospital administration is more suitable.

Conditions and MedDRA coding

HIV-Infected patients

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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 (plasma HIV-1 RNA levels < 50 copies/ml ) for ≥ 6 months preceding the study randomization.
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 partner1) from 14 days prior to the first IMP administration until at least 13 months after the last IMP administration; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol.
7. Patient who agrees to participate in the study and signs the informed consent.
8. Patients which have access to an out of hospital center in which can be treated without inconvenience

Exclusion criteria 6

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. To assess and compare acceptability, we will use the Acceptability Intervention Measure (AIM) questionnaire - Number and proportion of participants receiving injections that show an average composite score ≥ 4 across the AIM questionnaires at month 12.- Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires at month 12- Average composite score across the AIM questionnaires at 12.
2. To assess and compare the safety and tolerability of LA CAB+RPV: Incidence and severity of CAB + RPV LA–related AEs, all SAEs, ISRs or post injection reactions. % of participants who discontinue CAB + RPV LA due to AEs/SAEs at any time, and at m6&m12. Comparing between groups number and % of patients who withdraw treatment study at m6&m12 due to antiretroviral-related AE and reasons.Comparing between groups number and % patients whith grade 3 or 4 antiretroviral-related AEs at m6&m12.

Secondary endpoints 6

1. - Number and proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires at month 1 and 6, as perceived by the patient. - Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the AIM questionnaires at month 1 and 6. - Average composite score across the AIM questionnaires at month 1 and 6
2. - Number and proportion of participants receiving injections with an average composite score ≥ 4 across the IAM / FIM questionnaires at months 1, 6 and 12, as perceived by the patient. - Differences among the proportion of participants receiving injections with an average composite score ≥ 4 across the IAM /FIM questionnaires at month 1, 6 and 12. - Average composite score across the IAM /FIM questionnaires at month 1, 6 and 12.
3. - Number and proportion of HCP and/or nonclinical staff that show an average composite score ≥ 4 across the AIM / IAM /FIM questionnaires at months 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 at month 1, 6 and 12. - Average composite score across the AIM / IAM /FIM questionnaires at month 1, 6 and 12.
4. -Compare % patients high satisfaction baseline & 1, 6&12m (HIVTSQs12). -Assess satisfaction changes (HIVTSQs12) baseline to 1,6&12m .-Assess satisfaction changes (HIVTSQc12) baseline to 12m- Assess and compare groups expectations of LA CAB+RPV regarding areas.-Compare groups PROMs baseline& 1,6&12 m (PROMS- CST-HIV questionnaire). -Assess changes (PROMs) in groups baseline to 1,6 &12m.- Compare changes health professionals ‘expectations baseline to end-Compare perception of injection (PIN).
5. - Compare among groups number and proportion of patients who miss appointment LA CAB+RPV administration from baseline to month 6&12 - Compare among groups number and proportion of patients who early interrupt LA CAB+RPV every 2 months,at month 6&12. - Compare among groups number and proportion of patients who withdraw treatment study at month 6&12. - Time to LA CAB + RPV discontinuation. - Compare among groups the number and proportion of patients who adopt oral bridging therapy during 12months.
6. - 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 (Clinical study).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Sponsor organisation

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Address

Carretera Canyet S/n

City

Badalona

Postcode

08916

Country

Spain

Scientific contact point

Organisation

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Contact name

Eugenia Negredo

Public contact point

Organisation

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Contact name

Silvia Gel

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Sponsor organisation

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Address

Carretera Canyet S/n

City

Badalona

Postcode

08916

Country

Spain

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications