Chemsex Health Evaluation With Extended Release System for HIV Treatment

NCT06565013 | Not Yet Recruiting FDA Drug

• 1 other identifier: ACT001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Chemsex; Global health; Linkage to care; Switch; Vulnerable population; Long-acting; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of psychosocial linkage

  This study aims to demonstrate the impact of a switch to Cabenuva on patient engagement by measuring linkage to psychosocial care. The investigators will assess the proportion of participants who complete at least one psychosocial visit during the study.

  From baseline through month 11

Secondary Outcomes (13)

• Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score

  Baseline, month 5 and month 11

• Change in discourse on treatment and care satisfaction

  Baseline and month 11

• Change in the WHO Quality of life HIV questionnaire (brief version)

  Baseline, month 5 and month 11

• Frequency and severity of drug use

  Baseline, month 5 and month 11

• Frequency of detectable viremia

  24 months prior to baseline as well as from baseline through month 11

Study Arms (1)

CHEERS main

Switch from daily oral ART to Cabenuva, administered IM every two months. * Cabotegravir: 200mg/ml, 3ml per dose * Rilpivirine: 300mg/ml, 3ml per dose

Drug: Cabenuva 600/900; Other: Self administered questionnaires; Other: Semi-directed interview

Interventions

Cabenuva 600/900 DRUG

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.

CHEERS main

Self administered questionnaires OTHER

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

CHEERS main

Semi-directed interview OTHER

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.

CHEERS main

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Médicale L'Actuel: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Clinique Médicale l'Actuel

Montreal, Quebec, H2L4P9, Canada

Location

MeSH Terms

Conditions

Chemsex

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Jason Szabo, MD, PhD

  Clinique Médicale L'Actuel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Kajjo, PhD

CONTACT

5145241001; sam.kajjo@lactuel.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 21, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)