Clinical trial NCT03038763: Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers
Official title: Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Hepatitis C, Chronic
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2017-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult children of women born between 1945-1965 who have or have had hepatitis C Women born between 1945-1965 who have or have had hepatitis C

Investigators will only be recruiting subjects who are black or white as hepatitis C is most common in these two populations. Using these populations maximizes the generalizability of our results. HCV is not only significantly less common among Asian women and women of other races, but these women also represent a minority of the patient population at Penn.

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.


Eligibility criteria: 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

Exclusion Criteria:

Mothers:

- Unwilling to disclose hepatitis C status to children

Primary outcomes:
measure: HCV prevalence
timeFrame: Within 1 week of labwork at first study visit
Secondary outcomes:
measure: Liver fibrosis
timeFrame: Within 2 weeks of diagnosis of HCV
measure: HCV genotype
timeFrame: Within 6 weeks of diagnosis of HCV
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Goldberg, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
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