Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy

NCT05697289 | Unknown

• 1 other identifier: APHP221099
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Question arises as to whether this new treatment "Cabotegravir-rilpivirineactually" improves patient satisfaction and whether it is well suited to everyone, especially those with a history of irregular follow-up. Also, inconvenience of two intramuscular injections every two months and constraint of care organization could represent a barrier to treatment for some patients.

Conditions

HIV Infections

Keywords

hiv; Cabotegravir-rilpivirine

Outcome Measures

Primary Outcomes (1)

• treatment satisfaction in people living with HIV

  Change in human immunodeficiency virus Treatment Satisfaction Questionnaire (HIVTSQ12) status version score between conventional oral tri-therapy and after one year of intramuscular injectable bi-therapy.

  12 months

Secondary Outcomes (4)

• Proportion of patients who stopped treatment, median duration of treatment and reason for stopping.

  12 months

• Satisfaction : Change in human immunodeficiency virus Treatment Satisfaction Questionnaire (HIVTSQ12) status score between conventional oral triple therapy D0 and after 6 months of intramuscular dual therapy M6,

  12 months

• Compliance: number of patients who received an injection more than 7 days after the scheduled date

  12 months

• CD4 cells count

  12 months

Interventions

satisfaction survey OTHER

Non-comparative longitudinal observational study over 12 months conducted during usual follow-up of patients living with HIV-1 and having changed treatment for an injectable dual therapy with prolonged release cabotegravir-rilpivirine. Decision to change treatment and follow-up of patients are part of routine care. Study is proposed after the doctor has taken the decision to modify treatment, the patient has accepted and injectable dual therapy is prescribed. It is based on self-questionnaires to collect patient perceptions (Patient-Reported Outcomes) and clinical and biological data collected routinely at inclusion and during follow-up visits.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients living with HIV-1 and having changed treatment for an injectable dual therapy with prolonged release cabotegravir-rilpivirine.

You may qualify if:

• HIV-1 infected patient
• Patient over 18 years of age
• Patient for whom dual injectable sustained-release cabotegravir-rilpivirine therapy is implemented according to the decision of the referring physician in the context of care.
• Patient who understands, reads and writes French well

You may not qualify if:

• Patient opposing to participate in the study.
• Patient subject to legal protection measures (guardianship, curatorship or safeguard of justice)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Central Study Contacts

Lou MACAUX

CONTACT

01 48 95 54 21; lou.macaux@aphp.fr

Houda ALLALOU

CONTACT

0148957407; houda.allalou@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 25, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 25, 2023

Record last verified: 2022-01