Recruiting
Phase 3

Identigene

Sponsor:

Identigene

Code:

NCT01471392

Conditions

Infection

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

STD Diagnostic Kit (Identigene)

Study Details

Brief summary:

The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory. It is expected that this method will aid in detection of CT and NG and that offering a method of self-collection of a male urine or female vaginal swab specimen will encourage testing for CT and NG and improve the overall detection of reporting of these STDs by allowing persons who suspect they have the infection to be tested in a discrete and confidential manner. The reporting of CT and NG are underestimated and many subjects will not visit a clinic or obtain treatment if gone undetected. Thus, allowing a self-collection kit that is more convenient may result in improved reporting, identification of CT and NG positive individuals, and subsequent treatment to help prevent the spread of these diseases.

The purpose of this study is to demonstrate that the Identigene STD Test Collection Kit and labeled instructions for use instructions provide test results that are concordant (at least 95% or better) with test results obtained using the Gen-Probe APTIMA Combo 2 specimen collection and transport methods performed under the supervision of a healthcare provider. The laboratory technology and test method used for the IDTG-100.

Conditions

Infection

Study ID

NCT01471392

Start date

Nov, 2011

Status verified date

May, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Symptomatic females or males, age 14 or older, who present at a participating clinic with symptoms consistent with Chlamydia trachomatis or Neisseria gonorrhoeae infection, or
2. Asymptomatic females or males, age 14 or older, who present at a participating clinic and who suspect that they have CT and/or NG, or are considered at high risk of exposure (e.g., sexual partner that tests positive for CT, or NG, multiple sexual partners, ect.),
3. Individuals who are capable of understanding and agree to fulfill the requirements of the protocol.
4. Individuals who have signed the IRB approved informed consent form.

Exclusion Criteria:

1. Individuals with physical or mental inability that, in the opinion of the investigator can interfere with the subject's ability to follow the Identigene STD Test Collection Kit instructions,
2. Individuals who are currently being treated for CT or NG or who are currently receiving antibiotics or have received antibiotics within the last 28 days, and
3. Individuals who are suspected of being victims of sexual abuse or nonconsensual contact of a sexual nature within the previous 6 months or who are part of an ongoing sexual abuse legal case.

Study Design

Enrollment

3000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Identigene STD Test Kit Arm

Single-Arm trial where the group will complete the Identigene STD Test Kit at home and these results will be compared with the results from testing in the clinic with the Gen-Probe APTIMA kit. The subject will only be informed of the results from the approved test (Gen-Probe APTIMA) that is done in the clinic.

Interventions

STD Diagnostic Kit (Identigene)

The Identigene STD Test Collection Kit is an at-home kit that allows individuals to utilize the Gen-Probe technology to test for CT and NG in privacy and in a more convenient manner. The primary technology is the approved Gen-Probe APTIMA Combo 2 assay, which is repackaged into the Identigene kit for use by consumers. As such, the laboratory technology and testing method is identical to that of the Gen-Probe APTIMA Combo 2 assay, which has been cleared for in vitro diagnostic use.

Primary outcome measure

  • Effectiveness of the Identigene STD Test Collection Kit in comparison to the Gen-Probe Aptima Combo 2 Assay [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Michael Smith

801-859-7818mikes@lifetreeresearch.com

Locations

John Hopkins University

Recruiting

Baltimore, Maryland, United States

Contacts

Charlotte Gaydos, MD

410-614-0932cgaydos@jhmi.edu

Patricia Buist

410-614-0932cgaydos@jhmi.edu

Principal Investigator:

Charlotte Gaydos, MD

More Information

Sponsor

Identigene

Last update posted

Jun 3, 2013

Last verified

May, 2013

Keywords

  • Identigene
  • STD Test
  • Chlamydia
  • Gonorrhoeae
  • APTIMA
  • Sexually Transmitted Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Identigene on 2013-06-03.