Chemsex Health Evaluation With Extended Release System for HIV Treatment
NCT Number: NCT06565013
Acronym: CHEERS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HIV
Interventions: DRUG: Cabenuva 600/900|OTHER: Self administered questionnaires|OTHER: Semi-directed interview
Sponsor: Clinique Médicale L'Actuel
Collaborators: ViiV Healthcare
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-02
Locations: Clinique Médicale l'Actuel, Montréal, Quebec, H2L4P9, Canada

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., From baseline until the date of confirmed viral failure, assessed up to month 11