NCT00655434

Brief Summary

This study is designed to compare the performance of the Focus Diagnostics' HerpeSelect® Express, a Herpes Simplex Virus 2 Rapid Test, to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (capillary).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 9, 2009

Status Verified

January 1, 2009

Enrollment Period

2 months

First QC Date

April 2, 2008

Last Update Submit

January 8, 2009

Conditions

Herpes Simplex Virus 2

Keywords

Herpes simplex virus 2HSV 2Antibody status to Herpesvirus 2, Human

Outcome Measures

Primary Outcomes (1)

  • Compare serological status to predicate device

    End of study

Study Arms (1)

SAA

Sexually Active Adults- Intercourse in the last twelve months with at least one sexual partner. Subjects must be ≥ 18 years old. No more than 60% of one gender.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community based research clinic

You may qualify if:

  • Sexually Active Adults - Intercourse in the last twelve months with at least one sexual partner.
  • Subjects must be ≥ 18 years old.
  • No more than 60% of one gender.

You may not qualify if:

  • \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Clinical Research

Burbank, California, 91505, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 9, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 9, 2009

Record last verified: 2009-01

Locations

US(1)