Chemsex Health Evaluation With Extended Release System for HIV Treatment

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Другое 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
• Другое 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.

Первичные конечные точки

• Cumulative incidence of psychosocial linkage [Срок оценки: From baseline through month 11]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Clinique Médicale l'Actuel — Montreal

Идентификаторы

NCT: NCT06565013 · ACT001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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