HIVCHEERSNCT06565013
Chemsex Health Evaluation With Extended Release System for HIV Treatment
An observational study of HIV, run by Clinique Médicale L'Actuel at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- HIV
- What is being tested?
- Cabenuva 600/900, Self administered questionnaires and Semi-directed interview
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2024to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique Médicale l'Actuel
Montreal, Quebec, H2L4P9
Sam Kajjo, PhD, 5145241001 ext. 283, sam.kajjo@lactuel.ca
Jason Szabo, MD, PhD
About this study
Official 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
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
- Being tested
- Cabenuva 600/900, Self administered questionnaires, Semi-directed interview
- Keywords
- Chemsex, Global health, Linkage to care, Switch, Vulnerable population, Long-acting, Patient Reported Outcomes
- Medical subject headings
- Chemsex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabenuva 600/900Drug
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 questionnairesOther
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 interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Cabenuva 600/900; Other: Self administered questionnaires; Other: Semi-directed interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline through month 11
Secondary outcomes (13)
Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score
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.
Measured: Baseline, month 5 and month 11
Change in discourse on treatment and care satisfaction
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.
Measured: Baseline and month 11
Change in the WHO Quality of life HIV questionnaire (brief version)
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.
Measured: Baseline, month 5 and month 11
Frequency and severity of drug use
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.
Measured: Baseline, month 5 and month 11
Frequency of detectable viremia
This study aim to assess the change in frequency of detectable viremia before and after the switch to Cabenuva in a vulnerable population.
Measured: 24 months prior to baseline as well as from baseline through month 11
Attendance rate to clinical visits
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.
Measured: Up to 24 months prior to baseline and from baseline through month 11
Frequency rate of psychosocial visits
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.
Measured: Up to 24 months prior to baseline and from baseline through month 11
Number of psychosocial visits
This study aim to characterize the span of patient engagement as assessed by the number of psychosocial visits per participant who engage in care.
Measured: From baseline through month 11
Discontinuation rate
This study aim to characterize the span of patient engagement as assessed by the discontinuation rate to both clinical and psychosocial visits.
Measured: From baseline through month 11
Proportion of visits done outside window
This study aim to characterize the span of patient engagement as assessed by the proportion of clinical visits done outside the visit window.
Measured: From baseline through month 11
Frequency of AEs (safety)
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.
Measured: From baseline through month 11
Proportion of viral failure
This study aim to assess the maintenance of viral suppression by evaluating the proportion of viral failure at the end of the study.
Measured: From baseline until the date of confirmed viral failure, assessed up to month 11
Incidence of viral resistance development
For participants experiencing viral failure, this study aims to assess whether there is a development of drug resistance specifically to cabotegravir and rilpivirine.
Measured: From baseline until the date of confirmed viral failure, assessed up to month 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Médicale L'Actuel
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Jason Szabo, MD, PhD, Principal investigator, Clinique Médicale L'Actuel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565013
- Sponsor's protocol ID
- ACT001
- Acronym
- CHEERS
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06565013
- Acronym / sponsor ID
- CHEERS / ACT001
- Conditions
- HIV
- Keywords
- Chemsex, Global health, Linkage to care, Switch, Vulnerable population, Long-acting, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinique Médicale L'ActuelUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHEERS main | – | Drug: Cabenuva 600/900, Other: Self administered questionnaires, Other: Semi-directed interviewSwitch from daily oral ART to Cabenuva, administered IM every two months. * Cabotegravir: 200mg/ml, 3ml per dose * Rilpivirine: 300mg/ml, 3ml per dose |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabenuva 600/900Participants 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. | Drug | CHEERS main |
| Self administered questionnairesQuestionnaires on treatment satisfaction (HIVTSQs), quality of life (WHOQoL-HIV-BREF) and drug use assessment (DEBA-D) will be administered at baseline, M5 and M11 | Other | CHEERS main |
| Semi-directed interviewAt 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. | Other | CHEERS main |
Primary outcome
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.
13 secondary outcomes
Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score
Time frame: Baseline, month 5 and month 11
Change in discourse on treatment and care satisfaction
Time frame: Baseline and month 11
Change in the WHO Quality of life HIV questionnaire (brief version)
Time frame: Baseline, month 5 and month 11
Frequency and severity of drug use
Time frame: Baseline, month 5 and month 11
Frequency of detectable viremia
Time frame: 24 months prior to baseline as well as from baseline through month 11
Attendance rate to clinical visits
Time frame: Up to 24 months prior to baseline and from baseline through month 11
Frequency rate of psychosocial visits
Time frame: Up to 24 months prior to baseline and from baseline through month 11
Number of psychosocial visits
Time frame: From baseline through month 11
Discontinuation rate
Time frame: From baseline through month 11
Proportion of visits done outside window
Time frame: From baseline through month 11
Frequency of AEs (safety)
Time frame: From baseline through month 11
Proportion of viral failure
Time frame: From baseline until the date of confirmed viral failure, assessed up to month 11
Incidence of viral resistance development
Time frame: From baseline until the date of confirmed viral failure, assessed up to month 11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Szabo, MD, PhD principal investigator
Clinique Médicale L'Actuel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Clinique Médicale L'Actuel at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Kajjo, PhD (5145241001 ext. 283, sam.kajjo@lactuel.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of psychosocial linkage (time frame: From baseline through month 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.