NCT06565013

Chemsex Health Evaluation With Extended Release System for HIV Treatment

Impact of Increased Patient Engagement Associated With Cabotegravir (CAB) + Rilpivirine (RPV) Long-acting (LA) Administered Every Two Months on Virologically Suppressed People Living With HIV Who Are Practicing Chemsex

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Clinique Médicale L'Actuel · Academic / Other
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

CHEERS is an observational cohort for people living with HIV who are actively practicing chemsex and who are switching to CAB + RPV LA after being virologically suppressed on a stable oral ART regimen. This study aim to assess the impact of increased patient engagement associated with this LA regimen on linkage to psychosocial care and on global health outcomes, such as quality of life, substance use, treatment satisfaction and virological control. Eligible participants will need to be currently out of care for psychosocial counselling and will need to express the wish to switch to CAB + RPV LA. The participants will be followed in this study for 11 months from their first LA administration, according to the schedule of injections. In addition to standard of care procedures, such as blood draw and physical exam, patient reported outcome questionnaires will be administered at certain visits and a semi-directed interview will be conducted at the beginning and at the end of the study. CAB + RPV LA will be used in line with the Canadian monography.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Cabenuva 600/900	Participants will switch to Cabenuva at baseline. The visit schedule, the product administration and the clinical follow-up will be done according to standard of care.
OTHER	Self administered questionnaires	Questionnaires on treatment satisfaction (HIVTSQs), quality of life (WHOQoL-HIV-BREF) and drug use assessment (DEBA-D) will be administered at baseline, M5 and M11
OTHER	Semi-directed interview	At baseline and M11, participants will conduct a semi-directed interview about the perception of their HIV treatment and the global care they receive as a person living with HIV who is practicing chemsex.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-08-21
• Last updated: 2024-08-21

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study