Johns Hopkins University Institutional Review Board approved the study (NA_00036496). Non-pregnant adult women aged 18–45 and without genitourinary symptoms were recruited from the Baltimore, MD metropolitan area. After providing written informed consent, medical history was obtained to exclude women with active menstruation, genitourinary symptoms, or clinically apparent vaginal infections. Previous studies have shown mediator recovery was not affected by the sequence of FGT sample collection [28] (link), [29] (link). Therefore, among enrolled women, the following were collected in sequence: cervical swab for APTIMA2-Combo assay (GenProbe, San Diego, CA) for Chlamydia trachomatis and Neisseria gonorrhoeae, Dacron swab (Cardinal Health, McGraw Park, IL) of secretions from lateral vaginal wall for preparation of saline microscopy to evaluate for trichomoniasis and of Gram stain for assessment of Nugent criteria [30] (link); and for the biomarker analyses, Dacron swab of secretions from lateral vaginal wall, flocked swab (Seacliff Packaging, Inc., Newport Beach, CA) of secretions from lateral vaginal wall, Dacron swab of endocervical secretions, flocked swab of endocervical secretions, and finally CVL with one of three diluents. Women were randomly assigned to receive a 10 ml CVL of saline, tap water, or Normosol-R pH 7.4 (Hospira, Inc., Lake Forest, IL). Normosol-R is a sterile, isotonic balanced salt solution and contains 50.2 mg sodium gluconate per 10 ml. All women with symptomatic BV and STIs detected at screening were excluded and referred for appropriate management. We selected these exclusion criteria because they are typically employed in clinical trials studying prevention of HIV.
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