Chemsex Health Evaluation With Extended Release System for HIV Treatment

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Cumulative incidence of psychosocial linkage [Time frame: From baseline through month 11]

Secondary outcome measures (12)

• Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score [Time frame: Baseline, month 5 and month 11]
• Change in discourse on treatment and care satisfaction [Time frame: Baseline and month 11]
• Change in the WHO Quality of life HIV questionnaire (brief version) [Time frame: Baseline, month 5 and month 11]
• Frequency and severity of drug use [Time frame: Baseline, month 5 and month 11]
• Frequency of detectable viremia [Time frame: 24 months prior to baseline as well as from baseline through month 11]
• Attendance rate to clinical visits [Time frame: Up to 24 months prior to baseline and from baseline through month 11]
• Frequency rate of psychosocial visits [Time frame: Up to 24 months prior to baseline and from baseline through month 11]
• Number of psychosocial visits [Time frame: From baseline through month 11]
• Discontinuation rate [Time frame: From baseline through month 11]
• Proportion of visits done outside window [Time frame: From baseline through month 11]
• Frequency of AEs (safety) [Time frame: From baseline through month 11]
• Proportion of viral failure [Time frame: From baseline until the date of confirmed viral failure, assessed up to month 11]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Canada · 1 center

• Clinique Médicale l'Actuel — Montreal

Identifiers

NCT: NCT06565013 · ACT001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗