Quality of Life
Conditions
Keywords
Long-Acting Injectable Regimen, HIV, Patient-reported Outcomes, Treatment switch
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).
Interventions
Treatment switch to CAB+RPV LA
Sponsors
Hopital Foch
University Paris 7 - Denis Diderot
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Outcome results
None listed