Determination of HCV Prevalence in a HIV Patient Cohort in Phnom Penh, Cambodia

NCT02361541 | Completed

• 1 other identifier: HCV-Epi
• Study Type: observational
• Target: 3,045
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatitis C (HCV) is an important global public health problem, disproportionately affecting HIV positive populations. Asia and Africa account for most of the co-infection burden, but access to HCV screening and treatment is still very limited. It is expected though, with the recent therapeutic advances and increasing global advocacy efforts, that HCV treatment should become a feasible option in the near future. Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest HIV cohorts of the country, followed in an ambulatory settings. In this cohort, the prevalence of HCV co-infection will be determined, as well as HCV genotype diversity and the severity of liver disease. The researcher will also explore the performance of simple blood tests/panels as predictors of significant fibrosis and/or cirrhosis. Patients will attend two study-visits. All adult patients of the HIV patient cohort of SHCH will be proposed HCV testing during their next HIV follow-up consultation, following the latest algorithm of the Centre for Disease Control (CDC) (May 2013). Anamnesis and clinical examination will focus, additionally to routine practice, on presence of general and HCV liver-disease related features. Laboratory analyses will include basic HIV tests (CD4), and tests for liver function such as Hepatitis B surface antigen (HbsAg) . During the following routine HIV follow-up consultation, the results of HCV testing will be explained to the patient. If the patient is HCV negative, his/her study participation ends here. If currently infected with HCV, the clinician will repeat the HCV liver-disease (extra-hepatic \& hepatic) related anamnesis and clinical examination, and prescribe additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests, liver and kidney function. Patients will moreover be asked to undergo a liver ultrasound and liver stiffness measurements.

Conditions

Hepatitis C; HIV

Outcome Measures

Primary Outcomes (1)

• Seroprevalence of HCV infection

  Seroprevalence of HCV infection in the HIV patient cohort

  Baseline

Secondary Outcomes (5)

• Proportion of current HCV infection

  Baseline

• Proportion of HCV false-positives

  Baseline

• HCV genotypes

  Baseline

• Severity of liver disease in HCV patients

  Baseline

• HCV diagnostic accuracy

  Baseline

Study Arms (1)

HCV screening

All adult patients of an existing HIV cohort

Procedure: HCV screening

Interventions

HCV screening PROCEDURE

HCV antibody screening, liver function tests, full blood count and HbsAg will performed. Additional blood samples will be taken for further HCV diagnostic work-out (polymerase chain reaction (PCR) and genotyping). For patients with current HCV infection, liver ultrasound, transient elastography - Firbroscan and further lab analysis will be performed.

HCV screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients in a cohort of HIV-positive patients in Cambodia

You may qualify if:

• Adult (\> or = 18 years old)
• Documented HIV positive
• In regular HIV care follow-up (min. 2 consultations in the last six months prior to the study)
• Willing and able to provide written informed consent

You may not qualify if:

• HIV patients with currently taking Hepatitis C treatment or with a history of prior hepatitis C treatment

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

Sihanouk Hospital Center of HOPE (SHCH), Cambodia

Phnom Penh, Cambodia

Location

Related Publications (1)

• De Weggheleire A, De Baetselier I, An S, Goletti S, Suin V, Thai S, Francque S, Crucitti T, Lynen L, Van Gucht S, Kabamba BM. Challenges to Differentiate Hepatitis C Genotype 1 and 6: Results from A Field-Study in Cambodia. Infect Dis Ther. 2020 Sep;9(3):657-667. doi: 10.1007/s40121-020-00304-7. Epub 2020 May 30.

  PMID: 32474893 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Left over biological samples (whole blood plasma and serum)

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Anja De Weggheleire, MD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY DIRECTOR

• An Sokkab, MD

  Sihanouk Hospital Center of HOPE (SHCH), Cambodia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

CA (1)