Clinical Trials

MainTitle

HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)

This study is ongoing, but not recruiting participants.
Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborator
University of Health Sciences, Cambodia
Hopital Paul Brousse

Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT04044586

First received: August 1, 2019
Last updated: October 21, 2019
Last Verified: October 2019
History of Changes
Purpose

Purpose

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)

Condition
HIV Seropositivity
HCV Infection

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • 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. [ Time Frame: 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.
Secondary Outcome Measures:
  • 2/ Phylogenetic characterization of HCV strains circulating in these areas. 3/ Assessment of injection practices among tested subjects enrolled from the 2 studied communes. [ Time Frame: July 2019-December 2020 ]
    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.

Estimated Enrollment: 1098
Study Start Date: September 1, 2019
Estimated Study Completion Date: March 1, 2020
Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

Detailed Description:

Objectives

  1. 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

    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
    1. 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
    1. Sample size The formula for two-group comparison was used to calculate the sample size, taking into account the design effect and refusal rate. The minimum sample size of 366 is required per group. Therefore, the total sample size for the 3 groups of subjects in the 2 communes in Battambang will be 1,098 individuals.
    2. Sampling strategies A three-stage cluster sampling method will be used to select the eligible participants among residents in the 2 communes in Battambang. This sampling method will be done according to three steps. First, we will select Roka and Prey Khpos Khpos commune in the Battambang province (a commune that looks alike Roka in terms of number of inhabitants is selected). Second, the Simple Random sampling will be used to select 1414 clusters (which are groups) for each group of study population. Third, simple random sampling strategy will be used to select 26 households from each cluster (group) and only one person will be selected per household. The next adjacent household will be used if the person is not present after 3 visits in the first visited household. If more than one person occupies the visited household, one participant will be randomly selected for blood test and face-to-face interview with the research team. If the selected participant is a child, the face-to-face interviews will be done with parent/legal guardian.
    3. Data analysis plan

    Data analyses will include:
    • Description of the participants' demographic characteristics,
    • Comparison of HIV and HCV prevalence rates in 3 different groups (subjects living in Roka and Ambaeng Thngae villages of Roka commune, individuals living in the other 4 villages of the Roka commune, and people living in other villages of Prey Khpos commune in the Battambang) using Chi-squared test,
    • Comparison of injection history in subjects living in Roka and Ambaeng Thngae villages of Roka versus residents from other villages using Chi-squared test,
    • Comparison of viral strains circulating in Roka and Ambaeng Thngae villages of Roka
    commune versus those present in other villages.
    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

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Months and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: Yes  
    Sampling Method: Probability Sample  

    Study Population

    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.

    Criteria

    Inclusion Criteria:

    • 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


    Exclusion Criteria:
    • Children aged less than 18 months

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT04044586

    Locations

    Cambodia
    University of Health Sciences
    Phnom Penh, Cambodia

    Sponsors and Collaborators

    French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
    University of Health Sciences, Cambodia
    Hopital Paul Brousse

    Investigators

    Principal Investigator: Vonthanak SAPHONN University of Health Sciences, Cambodia
    More Information

    More Information


    Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)  
    ClinicalTrials.gov Identifier: NCT04044586   History of Changes  
    Other Study ID Numbers: ANRS 12352 ROK INVEST  
    Study First Received: August 1, 2019  
    Last Updated: October 21, 2019  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

    HIV
    HCV
    outbreak
    prevalence

    Additional relevant MeSH terms:
    Infection
    Communicable Diseases
    Hepatitis C
    HIV Seropositivity

    ClinicalTrials.gov processed this data on May 24, 2020
    This information is provided by ClinicalTrials.gov.