Patterns of Extragenital Chlamydia and Gonorrhea in Women and Men Who Have Sex With Men Reporting a History of Receptive Anal Intercourse.

BACKGROUND: Screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in men who have sex with men is risk based. Despite high frequencies of oral and receptive anal intercourse (RAI) among women, extragenital screening is not recommended. METHODS: Women (n = 175) and men who have sex with men (n = 224) primarily recruited from a sexually transmitted infection clinic reporting a lifetime history of RAI completed a structured questionnaire and clinician-collected swab samples from the rectum, pharynx, vagina (women), and urine (men). CT and GC were detected using 2 commercial nucleic acid amplification tests (Aptima Combo 2; Hologic, Inc, Bedford, MA; Xpert CT/NG, Cepheid Innovation, Sunnyvale, CA). RESULTS: The median age of the population was 26 years, 62% were white, and 88% were enrolled from a sexually transmitted disease clinic. Men were more likely than women to have GC (22.8% vs. 3.4%) and CT (21.9% vs. 12.6%). In men versus women, GC was detected in 16.5% versus 2.3% of pharyngeal swabs, 11.6% versus 2.3% of rectal swabs, and 5.4% versus 2.9% of urine samples or vaginal swabs. C. trachomatis was detected in 2.2% versus 1.7% of pharyngeal swabs, 17.4% versus 11.4% of rectal swabs, and 4.5% versus 10.3% for urogenital sites in men versus women. Overall 79.6% of CT and 76.5% of GC in men and 18.2% of CT and 16.7% of GC in women were detected only in the pharynx or rectum. CONCLUSION: Reliance on urogenital screening alone misses most of GC and CT in men and more than 15% of infections in women reporting RAI.

Limitations of the dye-based method for determining vaginal applicator use in microbicide trials.

BACKGROUND: A dye-based method for determining applicator usage in microbicide trials has been developed to assess whether applicators have been exposed to vaginal fluid. Our objective was to evaluate this method on polypropylene HTI applicators that are being widely used in several effectiveness trials of microbicides. METHODS: Study participants enrolled in a clinical trial assessing SPL7013 (VivaGel) inserted gel intravaginally twice daily for 14 days and returned used and unused applicators. Before staining, smears were prepared from each participant-inserted applicator, Gram stained and assessed independently for the presence of vaginal cells and bacteria. Of the 169 participant-inserted applicators, 168 (99%) had vaginal cells identified by Gram stain. PARTICIPANT: Inserted applicators were stained with a 0.05% FD & C blue dye No. 1 solution and compared with 70 inserted positive control applicators and 70 unused negative control applicators. Intravaginally inserted applicators should stain turquoise, whereas unused applicators should not retain any stain. The individual responsible for labeling and preparing the applicators did not serve as an evaluator. RESULTS: : Under optimized conditions, the sensitivity and specificity ranged from 81% to 95% and 86% to 93%, respectively for single use and unused applicators. The dye-based method was only 47% to 77% sensitive for participant-inserted applicators obtained from women using gel twice daily. CONCLUSION: The dye test for HTI polypropylene applicators had a sensitivity of 47% to 95%, depending on the evaluator and whether gel was present in the vagina. The sensitivity was decreased with multiple gel applications. The dye-based method cannot be recommended for HTI polypropylene applicators to monitor product adherence.