Trial Outcomes & Findings for Application of HBV Rapid Tests as a Tool for Wide-Use Screening (NCT NCT01767597)

Last Updated: 2016-12-13

Results Overview

Subjects who are considered required to seek further care are as follows: * those who need HBV vaccination (non-immunized) * those who are infected with hepatitis B virus (infected) Of these patients, subjects who have achieved appropriate care are considered as follows: * non immunized subjects who have initiated HBV vaccination sequence (vaccinated) * infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care) The percentage of patients appropriately seeking care will be then calculated by the following formula: ((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))\*100

Recruitment status

COMPLETED

Study phase

Target enrollment

1000 participants

Primary outcome timeframe

6 months

Results posted on

2016-12-13

Participant Flow

From 29 February 2012 to 5 July 2012, volunteers were recruited from five study centers in the Paris metropolitan region, which actively participate in HBV screening, vaccination, and care - two sexually transmitted disease clinics, one primary healthcare center, one general screening center, and one travel clinic.

2061 participants were initially screened for eligibility. Of them, 625 did not meet inclusion criteria and 436 declined to participate. In total, 1000 participants were randomized.

Participant milestones

Participant milestones
Measure	ELISA Testing HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).	Rapid Testing HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.
Overall Study STARTED	500	500
Overall Study COMPLETED	496	499
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ELISA Testing HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).	Rapid Testing HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.
Overall Study Incomplete intervention	3	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Application of HBV Rapid Tests as a Tool for Wide-Use Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ELISA Testing n=496 Participants HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).	Rapid Testing n=499 Participants HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.	Total n=995 Participants Total of all reporting groups
Age, Continuous	40.7 years STANDARD_DEVIATION 16.0 • n=5 Participants	40.1 years STANDARD_DEVIATION 15.6 • n=7 Participants	40.4 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	250 Participants n=5 Participants	272 Participants n=7 Participants	522 Participants n=5 Participants
Sex: Female, Male Male	246 Participants n=5 Participants	227 Participants n=7 Participants	473 Participants n=5 Participants
HBV prevalence of birth country Low (<2.0%)	292 participants n=5 Participants	275 participants n=7 Participants	567 participants n=5 Participants
HBV prevalence of birth country Intermediate (2.0-8.0%)	116 participants n=5 Participants	137 participants n=7 Participants	253 participants n=5 Participants
HBV prevalence of birth country High (>8.0%)	88 participants n=5 Participants	87 participants n=7 Participants	175 participants n=5 Participants
Health insurance plan Social security	465 participants n=5 Participants	472 participants n=7 Participants	937 participants n=5 Participants
Health insurance plan CMU	31 participants n=5 Participants	27 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).

Outcome measures

Outcome measures
Measure	ELISA Testing n=211 Participants HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).	Rapid Testing n=198 Participants HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.
Percentage of Patients Appropriately Seeking Care	5.7 percentage of participants	4.0 percentage of participants

Adverse Events

ELISA Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapid Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Bottero

Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine

Phone: +33 1 49 28 04 24

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place