Chemsex Health Evaluation With Extended Release System for HIV Treatment (CHEERS)

Clinique Médicale L'Actuel

Status: Not yet enrolling

Conditions: HIV

Treatments: Drug: Cabenuva 600/900; Other: Semi-directed interview; Other: Self administered questionnaires

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06565013

ACT001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Man, trans-woman or gender diverse person who was assigned male at birth and is over 18 y.o.

2. Actively practices chemsex, as assessed by self-reported use of substances (methamphetamine, GHB/GBL, ketamine and mephedrone) as a mean of prolonging sexual relations, intensifying sexual pleasure and/or exploring one's sexual subjectivity at least once in the last month prior to screening*.

3. Living with HIV-1 and virologically suppressed (plasma HIV RNA < 50 c/ml) on stable oral ART regimen for at least one month prior to screening.

4. Not currently receiving psychosocial support, either on site or outside of the clinic, as evaluated by an absence of self- reported psychosocial consultation in the last 3 months prior to screening.

5. Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

6. Participant is able to locally source Cabenuva, as this product is not provided in the context of this study.

   • If a patient only tried it once and it occurred in the last month prior to screening, we will consider that they meet the inclusion criteria, although we will focus on enrolling patients with a documented history of regular substance use, as pre-identified by chart review.

Exclusion Criteria

1. History or presence of allergy, resistance or intolerance to Cabotegravir or Rilpivirine, or drugs of their class.
2. Exposure to an experimental drug or experimental vaccine within 30 days prior to first dose of study treatment.
3. Alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN); or ALT 3xULN and bilirubin 1.5xULN (with >35% direct bilirubin).
4. Participant has estimated creatine clearance <30mL/min per 1.73 m2
5. Any concomitant condition or medication prohibited by local prescribing information.
6. Any condition judged by the investigator that may interfere with the study or the patient's well being if they were being enrolled.

Trial design

50 participants in 1 patient group

CHEERS main

Description:

Switch from daily oral ART to Cabenuva, administered IM every two months. * Cabotegravir: 200mg/ml, 3ml per dose * Rilpivirine: 300mg/ml, 3ml per dose

Treatment:

Other: Self administered questionnaires

Other: Semi-directed interview

Drug: Cabenuva 600/900