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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cumulative incidence of psychosocial linkage
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Cabenuva 600/900 (Drug)
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
干预措施: Self administered questionnaires (Other)
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
干预措施: Semi-directed interview (Other)
结局指标
主要结局
Cumulative incidence of psychosocial linkage
时间窗: 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.
次要结局
- Frequency of AEs (safety)(From baseline through 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)
- Incidence of viral resistance development(From baseline until the date of confirmed viral failure, assessed up to month 11)
- Frequency rate of psychosocial visits(Up to 24 months prior to baseline and from baseline through month 11)
- Number of psychosocial visits(From baseline through month 11)
- Discontinuation rate(From baseline through month 11)
- Change in the HIV Treatment Satisfaction Questionnaire (HIVTSQ) score(Baseline, month 5 and month 11)
- Attendance rate to clinical visits(Up to 24 months prior to baseline and from baseline through month 11)
- Proportion of visits done outside window(From baseline through month 11)
- Proportion of viral failure(From baseline until the date of confirmed viral failure, assessed up to month 11)