An observational study in HIV Seropositivity and HCV Infection, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 1 site in Cambodia. Open to participants aged 18 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by ANRS, Emerging Infectious Diseases · Observational
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:
Objectives
General objective
The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows:
Given the results we obtained during the investigation of the Roka nosocomial outbreak (2014-15), specific objectives are defined as follows:
Methodology This cross-sectional survey will be conducted prospectively in 2 communes in the Battambang Province, i.e. the Roka commune and Prey Khpos commune of the Battambang province. A total of 1,098 eligible residents will be selected according to a three-stage cluster sampling method conducted in the selected sites. A structure questionnaire will assess the medical injection practices through a 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 belonging to the Battambang Province.
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). If the result of HIV prevalence rates among group 2 and group 3 is lower or equal to 0.6% (HIV prevalence estimated in Cambodia), the phylogenetic study of HIV will NOT be performed.
A blood test will be done for HIV and HCV serological antibody screening. For the participants known as HIV positive and/or under ART treatment with NCHADS or as HCV positive, HCV and/or HIV antibody test will not be repeated for these participants and they will be considered as HCV and/or HIV positive. All individuals who will test positive for HCV will be further assessed for viral load measurements. In case of detectable VL results in plasma HCV strains will be amplified, sequenced, and characterized.
In the second step, all individuals who will test positive for HIV will be further assessed for viral load measurements. In case of detectable VL results in plasma or by using whole blood and/or peripheral blood mononuclear cells (PBMCs) in case of undetectable plasma HIV-1 RNA VL results, viral HIV strains will be amplified, sequenced, and characterized.
All tested participants will get a referral slip to retrieve their results (or those from their child) at health care center in the coverage area. Result disclosure will be provided by the doctor (or midwife or nurse) in each center. In case of positive result for at least one virus, we'll advice for the spouse to be tested as well. The same will be suggested for mothers and/or fathers whose child will be identified as infected. The transportation fee for this referral will be offered by the survey.
The total duration of this survey is expected to be 12 months.
Estimated enrollment 1,098 participants
Statistical methods
Data analyses will include:
Finally, multiple logistic regression models will be used to assess the independence of variables. All statistical analysis will be performed using STATA version 13.1 software (StataCorp LP, College Station, USA).
Survey timetable Survey start date: Second semester of 2019 Enrolment period: 2 months Subject participation duration: Cross-sectional study Total survey duration: 12 months Estimated survey/trial completion date: Second semester of 2020
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 1,098 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Three groups of subject will be selected: 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 belonging to the Battambang Province. The minimum sample size of 366 is required per group. Therefore, the total sample size for the 3 groups of subjects will be 1,098 individuals.
Exclusion Criteria:
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.
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.
Time frame: July 2019-December 2020
2/ Phylogenetic characterization of HCV strains circulating in these areas. 3/ Assessment of injection practices among tested subjects enrolled from the 2 studied communes.
The survey will assess the knowledge about medical injections practices and beliefs about efficacy of injections among participants using a questionnaire advocated by the WHO and based on previous results described in literature related to injection practices, consists of structured close-ended questions and will include basic demographic, history of medical injections or IV infusions, history of other medical practices as surgery, endoscopy, dental care, assessment of sexual risk behaviors, beliefs about the efficacy of injections and beliefs about the efficacy of parenteral injections. Other exposure factors will be also included in the questionnaire, such as blood transfusion, haemodialysis, tattooing, etc.
Time frame: July 2019-December 2020
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ANRS, Emerging Infectious Diseases