Chemsex Health Evaluation With Extended Release System for HIV Treatment
- Conditions
- HIV
- Registration Number
- NCT06565013
- Lead Sponsor
- Clinique Médicale L'Actuel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria<br><br> 1. Man, trans-woman or gender diverse person who was assigned male at birth and is over<br> 18 y.o.<br><br> 2. Actively practices chemsex, as assessed by self-reported use of substances<br> (methamphetamine, GHB/GBL, ketamine and mephedrone) as a mean of prolonging sexual<br> relations, intensifying sexual pleasure and/or exploring one's sexual subjectivity<br> at least once in the last month prior to screening*.<br><br> 3. Living with HIV-1 and virologically suppressed (plasma HIV RNA < 50 c/ml) on stable<br> oral ART regimen for at least one month prior to screening.<br><br> 4. Not currently receiving psychosocial support, either on site or outside of the<br> clinic, as evaluated by an absence of self- reported psychosocial consultation in<br> the last 3 months prior to screening.<br><br> 5. Participant is capable of giving written informed consent, which includes compliance<br> with the requirements and restrictions listed in the consent form and in this<br> protocol.<br><br> 6. Participant is able to locally source Cabenuva, as this product is not provided in<br> the context of this study.<br><br> - If a patient only tried it once and it occurred in the last month prior to<br> screening, we will consider that they meet the inclusion criteria, although we<br> will focus on enrolling patients with a documented history of regular substance<br> use, as pre-identified by chart review.<br><br>Exclusion Criteria<br><br> 1. History or presence of allergy, resistance or intolerance to Cabotegravir or<br> Rilpivirine, or drugs of their class.<br><br> 2. Exposure to an experimental drug or experimental vaccine within 30 days prior to<br> first dose of study treatment.<br><br> 3. Alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN); or ALT 3xULN<br> and bilirubin 1.5xULN (with >35% direct bilirubin).<br><br> 4. Participant has estimated creatine clearance <30mL/min per 1.73 m2<br><br> 5. Any concomitant condition or medication prohibited by local prescribing information.<br><br> 6. Any condition judged by the investigator that may interfere with the study or the<br> patient's well being if they were being enrolled.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of psychosocial linkage
- Secondary Outcome Measures
Name Time Method Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score;Change in discourse on treatment and care satisfaction;Change in the WHO Quality of life HIV questionnaire (brief version);Frequency and severity of drug use;Frequency of detectable viremia;Attendance rate to clinical visits;Frequency rate of psychosocial visits;Number of psychosocial visits;Discontinuation rate;Proportion of visits done outside window;Frequency of AEs (safety);Proportion of viral failure;Incidence of viral resistance development