Chemsex Health Evaluation With Extended Release System for HIV Treatment (NCT06565013) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chemsex Health Evaluation With Extended Release System for HIV Treatment
Canada50 participantsStarted 2024-08
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion criteria
✕. History or presence of allergy, resistance or intolerance to Cabotegravir or Rilpivirine, or drugs of their class.