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02588 PARTIAL USE OF COLPOSCOPY IN THE SAFETY EVALUATION OF A CANDIDATE MICROBICIDE Bollen, Liesbeth* Background. Colposcopy can be employed to evaluate the genital epithelium in microbicide safety trials. However, more genital findings may be identified during colposcopy than during naked-eye examination, and its partial use might bias safety outcomes. Methods. Safety of vaginal use of Carraguard (3% carrageenan gel) was compared with that of a placebo gel (2.5% methyl-cellulose) in a year-long, randomized, triple-blinded study among 165 HIV-negative women recruited from family planning clinics in northern Thailand. Colposcopy was performed at enrollment, day 14, and during monthly follow-up visits at the discretion of the study nurses. The use of colposcopy by five study nurses was recorded and patterns of use in the Carraguard and placebo gel groups were compared. Results. Study nurses reported performing colposcopy mostly to better visualize findings that were already visible by naked-eye examination. All five nurses evaluated roughly the same proportion of the 165 women enrolled in the study. Two study nurses performed colposcopy during one-quarter of the visits or less, while the other three used it during 40-50% of visits. However, rates of colposcope use by an individual nurse did not differ by Carraguard and placebo gel group. Although women with genital findings visible by naked eye may have been more likely to undergo colposcopy and women who underwent colposcopy may have been diagnosed with more genital findings, this occurred equally in both study groups. Conclusion. Safety outcomes were not biased by partial use of colposcopy. However, colposcopy was not systematically performed and we did not record which genital findings were only seen during colposcopy. We could therefore not evaluate the added value of performing colposcopy in the safety evaluation of a candidate microbicide, which we are currently investigating in another safety trial in Thailand. Dr Liesbeth J.M. Bollen |
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