Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers

Completed

• Conditions: Hepatitis C, Chronic; Hepatitis C
• Interventions: Other: Eligibility Screening; Diagnostic Test: HCV test

• Registration Number: NCT03038763
• Lead Sponsor: University of Pennsylvania

Brief Summary

The investigators aim to determine the prevalence of hepatitis C in the adult children of female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C testing was either not available or was not standard of care. Because of this, participants' children may be unaware of participants' risk of hepatitis C.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Study Start: 2017-05-11
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Mothers:

• Born between 1/1/45-12/31/64
• Black or white race
• Active or prior infection with hepatitis C
• Have at least one living adult child over the age of 18

Children:

• ≥18 years of age
• Born to mother with current or prior HCV infection, with likely timing of HCV acquisition prior to or during pregnancy
• Mother gave informed consent for child to be approached for study participation

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Exclusion Criteria

Mothers:

• Unwilling to disclose hepatitis C status to children

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mothers	Eligibility Screening	Black or white mothers who have or have had hepatitis C and were born between 1945-1964. Participants must have at least one child over the age of 18.
Adult Children	HCV test	Adult children of Black or white mothers who have or have had hepatitis C and were born between 1945-1964. From speaking with these mothers, it must be possible that participants were exposed to hepatitis C virus while in the womb.

Primary Outcome Measures

Name	Time	Method
HCV prevalence	Within 1 week of labwork at first study visit	Prevalence of HCV in adult children of female baby boomers who have or have had HCV

Secondary Outcome Measures

Name	Time	Method
Liver fibrosis	Within 2 weeks of diagnosis of HCV	Level of liver fibrosis (detected through fibrosure test) found in adult children diagnosed as HCV-positive
HCV genotype	Within 6 weeks of diagnosis of HCV	HCV genotype for adult children diagnosed as HCV-positive

Trial Locations

Locations (1)

Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States