Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,692
- 试验地点
- 2
- 主要终点
- Combined-testing uptake
研究概览
简要总结
Objectives Principal objective: to compare the effectiveness of a community-based intervention to a facility-based intervention to improve the combined-testing uptake (Antibody + RNA) of HCV infection among general population aged more than 40 years old in Cambodia Secondary objectives
- To compare the HCV antibody testing uptake between the 2 arms for the eligible population
- To compare the active case detection rate between the 2 arms for the eligible population
- To compare the linkage to care between the 2 arms for those with active infection
- To compare the cost-effectiveness of the two strategies
- To evaluate the treatment uptake
- To evaluate the effectiveness and safety of a 12-week dual-therapy of direct-acting antiviral (DAA) treatment
详细描述
Methodology: two-arms cluster-randomized controlled trial. Clusters are defined as a group of 50 households
Expected enrolment : 8000 patients in 160 clusters, 80 villages in each of the 2 provinces (Kompong Cham and Siem Reap)
Intervention
Arm 1: Facility-based testing intervention A team of community Health Workers (CHWs) will prepare a schedule to visit the selected villages and provide mass information on the possibility to be tested in health centers for HCV infection. Information will be provided using information sheet and a dedicated leaflet. If the participant agrees to participate, the signed consent form will be collected at this step. HCV testing will be done in one of the referrals health centers. HCV screening will be done using the SD Bioline HCV RDT on a finger stick capillary whole blood. Results will be available in 15 minutes. In case of positive HCV RDT, an immediate blood sample collection will be done in health center and sent to Provincial Hospital to perform HCV RNA using GenXpert viral load assay on plasma. Results will be sent back to the health center and nurses will be in charge to give result to the participant and to refer to care in case of active infection
Arm 2: Community-based testing intervention After a dedicated training, CHWs will do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the household of participant. Information will be provided by the CHW using information sheet and a dedicated leaflet. If the participant agrees to participate, the signed consent form will be collected at this step before any RDT collection. In case of structural or societal barriers for household testing, it will be possible to provide testing in a specific location in the village. The onsite visits will be planned with the head of village who will be in charge to inform the population about the study. In case of absence of participant during the first visit, a second visit will be scheduled. In absence of participant during the second visit, no additional visit will be planned. In case of positive HCV RDT, 5 blood spots will be collected immediately on DBS, dried at ambient temperature and put in an individual plastic bag with the ID number and sent to Phnom Penh (Rodolphe Merieux laboratory) for HCV RNA extraction and amplification (Omunis). Results will be sent back to the referral health center and nurses will be in charge to give result to the participant and to refer to care in case of active infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All persons aged more than 40 years old
- •Residing in the study area
- •Informed consent obtained with oral information given and explained and the consent form signed by the participant and the nurse hired by the study at the latest the time of the RDT realization
排除标准
- •Known positive HCV status with previous HCV treatment
- •Severe disease present at inclusion involving life threatening
- •Concurrent participation in any other clinical study without written agreement of the two study teams
研究组 & 干预措施
Facility-based testing intervention
- mass information on the possibility to be tested in health centers for HCV infection by CHWs ( information sheet and dedicated leaflet provided)
- signed consent form collected at this step
- HCV testing done in one of the referrals health centers, using the SD Bioline HCV RDT on a finger stick capillary whole blood.
- In case of positive HCV RDT, immediate blood sample collection done in health center and sent to Provincial Hospital to perform HCV RNA using GenXpert viral load assay on plasma.
- Results sent back to the health center and nurses in charge to give result to the participant and to refer to care in case of active infection
干预措施: Facility-based HCV rapid test (Other)
Facility-based testing intervention
- mass information on the possibility to be tested in health centers for HCV infection by CHWs ( information sheet and dedicated leaflet provided)
- signed consent form collected at this step
- HCV testing done in one of the referrals health centers, using the SD Bioline HCV RDT on a finger stick capillary whole blood.
- In case of positive HCV RDT, immediate blood sample collection done in health center and sent to Provincial Hospital to perform HCV RNA using GenXpert viral load assay on plasma.
- Results sent back to the health center and nurses in charge to give result to the participant and to refer to care in case of active infection
干预措施: Plasmatic HCV viral load (Other)
Community-based testing intervention
- dedicated training for CHWs to do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the household of participant.
- Information provided by the CHW (information sheet and a dedicated Leaflet)
- Signed consent form collected at this step.
- onsite visits planned with the head of village in charge to inform the population about the study
- In case of positive HCV RDT, 5 blood spots collected immediately on DBS and sent to Phnom Penh (Rodolphe Merieux laboratory) for HCV RNA extraction and amplification (Omunis)
- Results sent back to the referral health center and nurses in charge to give result to the participant and to refer to care in case of active infection
干预措施: Community-based HCV rapid test (Other)
Community-based testing intervention
- dedicated training for CHWs to do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the household of participant.
- Information provided by the CHW (information sheet and a dedicated Leaflet)
- Signed consent form collected at this step.
- onsite visits planned with the head of village in charge to inform the population about the study
- In case of positive HCV RDT, 5 blood spots collected immediately on DBS and sent to Phnom Penh (Rodolphe Merieux laboratory) for HCV RNA extraction and amplification (Omunis)
- Results sent back to the referral health center and nurses in charge to give result to the participant and to refer to care in case of active infection
干预措施: DBS HCV viral load (Other)
结局指标
主要结局
Combined-testing uptake
时间窗: 12 months
Combined-testing uptake defined as the number of persons tested for HCV RDT AND HCV RNA and aware of their status among the total number of persons eligible residing in the region where the intervention takes place
次要结局
- Linkage to care(12 months)
- HCV antibody testing uptake(12 months)
- Active case detection rate(12 months)