HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,098
- 试验地点
- 1
- 主要终点
- Determination of HIV and HCV prevalence rates in 2 communes in Battambang province, as well as basic epidemiological risk factors associated with HIV and HCV infections.
研究概览
简要总结
This cross-sectional survey will be conducted prospectively in 2 communes in the Battambang Province, Roka and Prey Khpos commune. The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows:
- Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak in 2014-2015
- Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak)
- Group 3: subjects living in selected villages from Prey Khpos commune 1,098 eligible residents will be selected using three-stage cluster sampling method. A structure questionnaire will assess the medical injection practices through face-to-face interview. The study will be conducted into two steps. The first step will be a prevalence study to assess HIV and HCV prevalence rates in three groups of subject; Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak; Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak) and Group 3: subjects living in villages from Prey Khpos commune).The second step will be the phylogenetic study of HIV. The phylogenetic study of HIV will be performed ONLY if HIV prevalence rates among group 2 and/or group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia)
详细描述
Objectives
- General objective
The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows:
- Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak in 2014-2015
- Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak)
- Group 3: subjects living in selected villages from Prey Khpos commune belonging to the Battambang Province.
- Specific objectives
Given the results we obtained during the investigation of the Roka nosocomial outbreak (2014-15), specific objectives are defined as follows:
- Risk of geographical spread of clustered HCV strains from Roka or Ambaeng Thngae villages to other villages of the Roka commune
- Risk of geographical spread of clustered HIV strains from Roka or Ambaeng Thngae villages to other villages of the Roka commune if the HIV prevalence of Group 2 and/or Group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia).
- Comparison of unsafe injection and/or medical practices between the three groups
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged from 18 months to 14 years old
- •Adult aged ≥ 15 years old
- •Informed consent from the participant/parents
- •Resident from the selected villages
排除标准
- •Children aged less than 18 months
结局指标
主要结局
Determination of HIV and HCV prevalence rates in 2 communes in Battambang province, as well as basic epidemiological risk factors associated with HIV and HCV infections.
时间窗: July 2019-December 2020
For the initial screening, ELISA techniques (Murex) will be used for HIV and HCV antibody (Ab) testing. In case of Ab positivity (for HIV and HCV), VL testing will be performed using the Biocentric HIV RNA assay, and the Omunis HCV RNA Viral Load technique. In case of detectable (\>1,000 copies/ml) HIV and/or HCV VL results or using peripheral blood mononuclear cells (PBMCs) and/or DBS in case of undetectable plasma HIV-1 RNA VL results, viral strains will be amplified and sequenced by Macrogen as follows: C2V3 env region for HIV, and NS5B gene for HCV. The phylogenetic analyses will be done for HCV and for HIV using maximum likelihood tree inference and Bayesian evolutionary analyses to obtain temporal information about the date of origin and age of strains (according to 'molecular clock' approaches). Phylogenetic analysis will be performed with the MEGA6 and BEAST softwares.
次要结局
- 2/ Phylogenetic characterization of HCV strains circulating in these areas. 3/ Assessment of injection practices among tested subjects enrolled from the 2 studied communes.(July 2019-December 2020)