Clinical and Laboratory Core
Anna Wald, MD, MPH
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.
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
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).
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.