Clinical trial NCT06565013: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV
Keywords: Chemsex
Global health
Linkage to care
Switch
Vulnerable population
Long-acting
Patient Reported Outcomes
Lead sponsor: Clinique Médicale L'Actuel
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2024-08-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults living with HIV on daily oral ART who are actively practicing chemsex and who are not currently involved in a psychosocial follow-up.

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.


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.

   * 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.

Primary outcomes:
measure: Cumulative incidence of psychosocial linkage
timeFrame: From baseline through month 11
Secondary outcomes:
measure: Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score
timeFrame: Baseline, month 5 and month 11
measure: Change in discourse on treatment and care satisfaction
timeFrame: Baseline and month 11
measure: Change in the WHO Quality of life HIV questionnaire (brief version)
timeFrame: Baseline, month 5 and month 11
measure: Frequency and severity of drug use
timeFrame: Baseline, month 5 and month 11
measure: Frequency of detectable viremia
timeFrame: 24 months prior to baseline as well as from baseline through month 11
measure: Attendance rate to clinical visits
timeFrame: Up to 24 months prior to baseline and from baseline through month 11
measure: Frequency rate of psychosocial visits
timeFrame: Up to 24 months prior to baseline and from baseline through month 11
measure: Number of psychosocial visits
timeFrame: From baseline through month 11
measure: Discontinuation rate
timeFrame: From baseline through month 11
measure: Proportion of visits done outside window
timeFrame: From baseline through month 11
measure: Frequency of AEs (safety)
timeFrame: From baseline through month 11
measure: Proportion of viral failure
timeFrame: From baseline until the date of confirmed viral failure, assessed up to month 11
measure: Incidence of viral resistance development
timeFrame: From baseline until the date of confirmed viral failure, assessed up to month 11
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Médicale l'Actuel
state: Quebec
Study officials:
affiliation: Clinique Médicale L'Actuel
name: Jason Szabo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: