Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine
- Conditions
- Quality of Life
- Interventions
- Drug: Cabotegravir, Rilpivirine Drug Combination
- Registration Number
- NCT06403865
- Lead Sponsor
- University Paris 7 - Denis Diderot
- Brief Summary
Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window.
Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment.
Population People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV.
Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 280
- HIV-1 carriers
- Patients who changed treatment (as part of routine care) to injectable CAB+RPV at the same visit as the inclusion visit
- HIV-RNA less than or equal to 50 copies/mL for at least 6 months prior to inclusion visit
- Patient 18 years of age or older
- Patient able to read, understand and answer self-questionnaires in French
- Pregnant or breast-feeding women
- Known hypersensitivity to cabotegravir or rilpivirine
- Documented resistance to cabotegravir or rilpivirine
- Chronically active hepatitis B (HBsAg+)
- Any pathology or history of treatment which, in the investigator's judgment, would contraindicate the patient's inclusion in the study or prevent him/her from following the constraints of the protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PLWHIV Cabotegravir, Rilpivirine Drug Combination People living with HIV-1
- Primary Outcome Measures
Name Time Method Treatment Impact - PROQOL-HIV between D0 (baseline) and 15 months after the first injection of CAB+RPV LA Evolution of the score of the "Treatment impact (TI)" dimension of the PROQOL-HIV questionnaire (10 items)
- Secondary Outcome Measures
Name Time Method