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NCT Number: NCT06565013

Chemsex Health Evaluation With Extended Release System for HIV Treatment

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.

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Key information

Conditions

HIV Behavior Chemsex Sexual Behavior

Age range

18 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

Clinique Médicale l'Actuel

Montreal, Quebec, H2L4P9, Canada

Location contact

Jason Szabo, MD, PhD

PRINCIPAL_INVESTIGATOR

Sam Kajjo, PhD

CONTACT

[email protected]

5145241001 ext. 283

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

  • 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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Cumulative incidence of psychosocial linkage

    Time frame: From baseline through month 11

    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.

Secondary outcomes

  1. Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score

    Time frame: Baseline, month 5 and month 11

    This study aims to assess the reported treatment satisfaction before and after a switch to Cabenuva by measuring the change in HIVTSQs scores. The sacle is from 0 to 6.A higher score is associated with a higher satisfaction.

  2. Change in discourse on treatment and care satisfaction

    Time frame: Baseline and month 11

    This study aims to assess the reported treatment satisfaction before and after the switch to Cabenuva by measuring the change in perception of HIV treatment and care, as assessed by a semi-directed interview. Thematic content analysis (TCA) will be used to identify changes. The investigators will evaluate the change for people who initiated a psychosocial follow-up and for those who didn't.

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

    Time frame: Baseline, month 5 and month 11

    This study aim to assess the perceived quality of life before and after a switch to Cabenuva, as measured by change in WHOQoL-HIV-BREF (quality of life questionnaire) score throughout the study. the scale score is from 4-20.A higher score is associated with a higher quality of life.

  4. Frequency and severity of drug use

    Time frame: Baseline, month 5 and month 11

    This study aim to assess the frequency and severity of drug use before and after switch to Cabenuva, as measured by the change in DEBA-D (drug use assessment questionnaire) score throughout the study. The scale score is from 0-15. A higher score is associated with a more frequent and severe use of drugs.

  5. Frequency of detectable viremia

    Time frame: 24 months prior to baseline as well as from baseline through month 11

    This study aim to assess the change in frequency of detectable viremia before and after the switch to Cabenuva in a vulnerable population.

  6. Attendance rate to clinical visits

    Time frame: Up to 24 months prior to baseline and from baseline through month 11

    This study aim to characterize the span of patient engagement as assessed by the change in attendance rate to clinical visits before and after switch to Cabenuva.

  7. Frequency rate of psychosocial visits

    Time frame: Up to 24 months prior to baseline and from baseline through month 11

    This study aim to characterize the span of patient engagement as assessed by change in frequency of psychosocial visits before and after switch to Cabenuva (only applicable to participants who had previously disengaged from psychosocial care and who initiated a psychosocial follow-up in the context of this study).

    For each participant, we will compare the frequency rate of psychological visits they attended during the 24 months before screening to the frequency of visits they attended during the 11-month period from baseline (Day 1) to Month 11. We anticipate three possible outcomes:

    The frequency rate of psychological visits increased, The frequency rate of psychological visits decreased, or The frequency rate of psychological visits stayed the same.

  8. Number of psychosocial visits

    Time frame: From baseline through month 11

    This study aim to characterize the span of patient engagement as assessed by the number of psychosocial visits per participant who engage in care.

  9. Discontinuation rate

    Time frame: From baseline through month 11

    This study aim to characterize the span of patient engagement as assessed by the discontinuation rate to both clinical and psychosocial visits.

  10. Proportion of visits done outside window

    Time frame: From baseline through month 11

    This study aim to characterize the span of patient engagement as assessed by the proportion of clinical visits done outside the visit window.

  11. Frequency of AEs (safety)

    Time frame: From baseline through month 11

    This study aim to assess the safety of Cabenuva in this population by evaluating the frequency of serious AE or drug related AEs, including site injection reactions.

  12. Proportion of viral failure

    Time frame: From baseline until the date of confirmed viral failure, assessed up to month 11

    This study aim to assess the maintenance of viral suppression by evaluating the proportion of viral failure at the end of the study.

  13. Incidence of viral resistance development

    Time frame: From baseline until the date of confirmed viral failure, assessed up to month 11

    For participants experiencing viral failure, this study aims to assess whether there is a development of drug resistance specifically to cabotegravir and rilpivirine.

Study contacts

Contact information is provided by the study sponsor or research team.

Sam Kajjo, PhD

CONTACT

[email protected]

5145241001 ext. 283

Sponsors and collaborators

Lead sponsor

Clinique Médicale L'Actuel

Other

Collaborators

  • ViiV Healthcare

Registry information

Official study 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

Acronym: CHEERS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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