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Determination of HCV Prevalence in a HIV Patient Cohort in Phnom Penh, Cambodia (HCV-Epi)

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ClinicalTrials.gov Identifier: NCT02361541
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : May 16, 2016
Sponsor:
Collaborators:
Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia
Universiteit Antwerpen
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Tracking Information
First Submitted Date February 6, 2015
First Posted Date February 11, 2015
Last Update Posted Date May 16, 2016
Study Start Date November 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2015)
Seroprevalence of HCV infection [ Time Frame: Baseline ]
Seroprevalence of HCV infection in the HIV patient cohort
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 6, 2015)
  • Proportion of current HCV infection [ Time Frame: Baseline ]
    Proportion of currently infected with HCV among the HCV-IgG positive HIV patients
  • Proportion of HCV false-positives [ Time Frame: Baseline ]
    Proportion of HCV biologically false-positives among HCV-IgG positive screening
  • HCV genotypes [ Time Frame: Baseline ]
    Proportions of different HCV genotypes
  • Severity of liver disease in HCV patients [ Time Frame: Baseline ]
    To determine the severity of liver disease by transient elastography in this coinfected cohort
  • HCV diagnostic accuracy [ Time Frame: Baseline ]
    To compare the diagnostic accuracy of commonly available blood panel tests for fibrosis staging in this coinfected cohort, with liver stiffness measurement (considered as reference standard).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of HCV Prevalence in a HIV Patient Cohort in Phnom Penh, Cambodia
Official Title Determination of Hepatitis C Prevalence, Genetic Diversity and Treatment Eligibility in an HIV Patient Cohort in Phnom Penh, Cambodia
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.

Detailed Description

Hepatitis C (HCV) is an important global public health problem, disproportionally 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. The high cost and complexity of current diagnostic and treatment algorithms are major bottlenecks and the linked lack of accurate HCV prevalence estimates and treatment-need data do not allow for robust treatment advocacy and program planning. Cambodia is not an exception.

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, and it is planning to engage in HCV treatment from 2014 2015 onwards, with a double objective of direct patient benefit and catalyst role at national level, as in the past when starting its antiretroviral (ARV) program.

Within this specific setting, the researchers plan to determine the prevalence of HCV co-infection, HCV genotype diversity and severity of liver disease in this HIV patient cohort, followed in an ambulatory setting. The researchers will also explore the performance of simple blood tests/panels as predictors of significant fibrosis and/or cirrhosis .

The current HCV diagnostic procedures (and tools), as applied in this study, are too expensive and resource-demanding to allow for scalability in resource limited settings. Thus, the researchers plan to set up during this study a biobank with samples of a clinically well described HIV patient population. These samples should allow constituting a well-balanced panel for evaluation of future 'more scalable' HCV diagnostic tools.

Patients will attend two study-visits. All adult patients of the HIV cohort will be proposed HCV testing during their next regular HIV follow-up consultation. HCV testing will follow the latest algorithm of the Centre for Disease Control (CDC) (May 2013). During this same consultation, anamnesis and clinical examination will focus, additionally to routine practice ,on presence of general and HCV liver-disease related features. Laboratory analyses will also include basic HIV (CD4), and tests for liver function such as Hepatitis B surface antigen (HbsAg).

During the following routine HIV follow-up consultation (2-3 months later), 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 Hepatitis C, 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.

The biobank will be set up with left over biological samples (whole blood plasma and serum) and comprehensive clinical information of all patients who give additional consent for this scope. Both biological samples and clinical information will be coded, to ensure confidentiality.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Left over biological samples (whole blood plasma and serum)
Sampling Method Non-Probability Sample
Study Population All adult patients in a cohort of HIV-positive patients in Cambodia
Condition
  • Hepatitis C
  • HIV
Intervention Procedure: HCV screening
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.
Study Groups/Cohorts HCV screening
All adult patients of an existing HIV cohort
Intervention: Procedure: HCV screening
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 13, 2016)
3045
Original Estimated Enrollment
 (submitted: February 6, 2015)
2700
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Cambodia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02361541
Other Study ID Numbers HCV-Epi
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Institute of Tropical Medicine, Belgium
Study Sponsor Institute of Tropical Medicine, Belgium
Collaborators
  • Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia
  • Universiteit Antwerpen
Investigators
Study Director: Anja De Weggheleire, MD Institute of Tropical Medicine, Antwerp, Belgium
Principal Investigator: An Sokkab, MD Sihanouk Hospital Center of HOPE (SHCH), Cambodia
PRS Account Institute of Tropical Medicine, Belgium
Verification Date May 2016