Chemsex Health Evaluation With Extended Release System for HIV Treatment

NCT ID: NCT06565013

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-02-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CHEERS main

Switch from daily oral ART to Cabenuva, administered IM every two months.

• Cabotegravir: 200mg/ml, 3ml per dose
• Rilpivirine: 300mg/ml, 3ml per dose

Cabenuva 600/900

Intervention Type: DRUG

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.

Self administered questionnaires

Intervention Type: OTHER

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

Semi-directed interview

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: collaborator

Clinique Médicale L'Actuel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Szabo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinique Médicale L'Actuel

Locations

Clinique Médicale l'Actuel

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Sam Kajjo, PhD

Role: CONTACT

sam.kajjo@lactuel.ca

5145241001 ext. 283

Facility Contacts

Sam Kajjo, PhD

Role: primary

sam.kajjo@lactuel.ca

5145241001 ext. 283

Other Identifiers

ACT001

Identifier Type: -

Identifier Source: org_study_id