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

NCT04044586 | Unknown

• 1 other identifier: ANRS 12352 ROK INVEST
• Study Type: observational
• Target: 1,098
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

HIV Seropositivity; HCV Infection

Keywords

HIV; HCV; outbreak; prevalence

Outcome Measures

Primary Outcomes (1)

• 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.

  July 2019-December 2020

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Children aged less than 18 months

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• University of Health Sciences, Cambodia: collaborator
• Hopital Paul Brousse: collaborator

Study Sites (1)

University of Health Sciences

Phnom Penh, Cambodia

Location

MeSH Terms

Conditions

HIV Seropositivity; Hepatitis C

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Vonthanak SAPHONN

  University of Health Sciences, Cambodia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: September 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: March 1, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

CA (1)