The Clinical and Laboratory Core for the University of Washington (UW) STI CRC is located in dedicated clinical research space on the 11th floor of a newly constructed building on the UW-Harborview Medical Center campus. The research clinicians and coordinators who work at the Clinical Core have many years of experience in STI-related research. This Core has been the site of innovations in STI research, most notably the use of participant-collected genital swabs to understand the host-pathogen interaction in genital herpes as well as the vaginal microbiome. The CRC laboratory facilities are accredited UW reference laboratories staffed by experienced technologists with faculty oversight. The Clinical Core will recruit, evaluate and retain participants to provide clinical specimens for study in Projects 1, 2, 3, and 4. In addition, the Core will provide the laboratory expertise needed to assess eligibility for study entry, diagnose baseline and intercurrent infections, and coordinate routine laboratory testing, including diagnostic testing for common STI and Gram stains for evaluation of Nugent score.
Our aims are:
Specific Aim 1. To recruit, enroll, and retain participants into research protocols from defined populations, including characterization of baseline infection status through antibody tests (HIV and HSV-2) and nucleic acid amplifications tests (NAAT) for N. gonorrhoeae, C. trachomatis, T. vaginalis and M. genitalium.
Specific aim 2. To obtain clinical specimens required for the Research Projects, including: 1) Vaginal swabs for characterization of bacterial communities (see Microbiome Core) and for Nugent score in Projects 1, 2 &4; 2) Swabs for HSV PCR assay from mucosal sites for Projects 1 &4;3) Cervicovaginal lavage and cervical cytobrush for immune mediator studies in Projects 1 &4;and 4) Urethral swabs from men for characterization of bacterial communities (Project 3).
Specific Aim 3. To ensure the integrity of data collected for all Projects by adhering to study procedures and promoting the highest standards of human subjects research, including adherence to Good Clinical Practices.