Genital signs in women with and without laboratory confirmed STIs in MDP301.
Background: Syndromic management guidelines for sexually transmitted infections (STIs) are utilised in settings without laboratory testing. The MDP phase III trial of the vaginal microbicide PRO 2000/5 affords an opportunity to examine correlations between syndromic and laboratory detection in such settings. The objective was to determine the proportion of women with laboratory confirmed STI diagnoses who displayed the genital signs likely to trigger appropriate syndromic treatment at baseline. Methodology Laboratory diagnoses of Chlamydia trachomatis (CT), Neisseria gonorrheae (NG), and Trichomonas vaginalis (TV), and the corresponding clinical forms from enrolment, were available for 4802 women in the combined database in June 2007. Associations of discharge and cervico-vaginal redness with CT/ NG/TV were explored. Results There was no discharge in 74% of 311 CT +ve, 74% of 118 NG +ve, and 75% of 307 TV+ve women, and no cervico-vaginal redness in 94% CT+ve, 99% of NG+ve and 98% of TV+ve women. Laboratory confirmed infections in women with abnormal discharge (n=614) were low: CT, NG and TV prevalence of 14%, 4% and 15% respectively. These were slightly higher than in women without abnormal discharge: CT (9%), NG (3%) and TV (8%). 16%, 1% and 6% of women with cervicovaginal redness (n=125) had CT, NG and TV respectively. Although women without redness were less likely to have CT (10%), they were more likely to have NG (3%) or TV (9%) than women with redness. Conclusions: Most women with laboratory confirmed STIs did not exhibit the genital signs necessary to trigger syndromic treatment, and would have continued undetected without laboratory screening. Conversely, many women that had genital signs likely to result in broad spectrum antibiotic therapy did not have the specific STIs that the drugs are intended for. This highlights the limitations of syndromic management, and the need to develop cheap, rapid point of care tests applicable to settings without laboratory facilities.
Mathur, R. Genital signs in women with and without laboratory confirmed STIs in MDP301. Presented at Microbicides 2008, New Delhi, India, 24-27 February 2008. (2008)