Sexually Transmitted Infections Clinical Trial
Official title:
Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia Trachomatis in Extragenital Sites
The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.
Background & Significance: Infections due to Neisseria gonorrhoeae (NG) and Chlamydia
trachomatis (CT) are major threats to public health. Most CT and NG infections are
asymptomatic, but infection can lead to serious sequelae, including infertility, chronic
pelvic pain, adverse obstetrical outcomes, increased risk of acquiring the human
immunodeficiency virus (HIV), and disseminated infection.
There has also been growing concern over antibiotic resistance. In 2013, the US Centers for
Disease Control and Prevention (CDC) classified drug-resistant NG as one of the three
urgent-level resistant bacteria. Improved detection of extragenital NG is thought to be a
crucial component of adequate treatment and for prevention of further resistance.
Currently, the CDC recommends using NAATs to screen and diagnose for NG and CT in the
genitourinary tract due to their superior sensitivity compared to traditional culture
methods. There are currently no FDA-approved commercial NAAT tests for the detection of
pharyngeal and rectal NG or CT infections. The goal of this study is to evaluate the
diagnostic performance of three NAAT assays for detection of extragenital NG and CT
infections.
Design & Procedures: A cross-sectional, single visit study evaluating the performance of
three commercial NAATs to detect NG and CT in the rectum and pharynx. A fourth NAAT will be
used as a tiebreaker. The performance of the fourth NAAT will not be evaluated. Each
manufacturer will provide a specific swab collection kit and transport media.
This research study will take place at healthcare clinics that focus on sexually transmitted
infections, women's health, student health, family planning, and lesbian, gay, bisexual, and
transgender (LGBT) health. This research will include specimens collected from adult males,
females, and transgender persons seeking sexually transmitted infection (STI) testing at the
participating study clinics. Both symptomatic and asymptomatic participants are included in
the study population.
Potential participants will be identified, assessed for eligibility, and asked to provide
oral informed consent. If a potential participant agrees to take part in the research, the
participant will have eight total swabs collected: four swabs from the pharynx and four swabs
from the rectum. The swabs needed for routine clinical care are taken first prior to
collection of the research study swabs. All study procedures take place during one clinic
visit; there are no follow-up visits as part of the study. Participants continue with routine
clinical care as directed by their medical providers.
Subject participation is confidential and anonymous. The results of the tests and
participation in this research are not placed in the participant's medical records.
Each study swab is used for a specific NAAT and tested at one of the two reference testing
laboratories. The Anatomic Site Infection Status (ASIS) is defined by the results of the two
other NAATs, and, if necessary, results from the tiebreaker NAAT. Each anatomic site is
considered in isolation. If fewer than four swabs at an anatomic site are completed, then the
test results from that specific anatomic site are excluded from analysis.
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