Chemsex Health Evaluation With Extended Release System for HIV Treatment
- Conditions
- HIV
- Interventions
- Drug: Cabenuva 600/900Other: Self administered questionnairesOther: Semi-directed interview
- Registration Number
- NCT06565013
- Lead Sponsor
- Clinique Médicale L'Actuel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CHEERS main Self administered questionnaires Switch from daily oral ART to Cabenuva, administered IM every two months. * Cabotegravir: 200mg/ml, 3ml per dose * Rilpivirine: 300mg/ml, 3ml per dose CHEERS main Cabenuva 600/900 Switch from daily oral ART to Cabenuva, administered IM every two months. * Cabotegravir: 200mg/ml, 3ml per dose * Rilpivirine: 300mg/ml, 3ml per dose CHEERS main Semi-directed interview Switch from daily oral ART to Cabenuva, administered IM every two months. * Cabotegravir: 200mg/ml, 3ml per dose * Rilpivirine: 300mg/ml, 3ml per dose
- Primary Outcome Measures
Name Time Method Cumulative incidence of psychosocial linkage 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 Outcome Measures
Name Time Method Frequency of AEs (safety) 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.
Change in discourse on treatment and care satisfaction 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.
Change in the WHO Quality of life HIV questionnaire (brief version) 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.
Frequency and severity of drug use 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.
Frequency of detectable viremia 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.
Frequency rate of psychosocial visits 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.Number of psychosocial visits 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.
Discontinuation rate 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.
Incidence of viral resistance development 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.
Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score 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.
Attendance rate to clinical visits 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.
Proportion of visits done outside window 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.
Proportion of viral failure 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.
Trial Locations
- Locations (1)
Clinique Médicale l'Actuel
🇨🇦Montréal, Quebec, Canada