title: Sexual behavior before and after pregnancy detection in four microbicide trials.
abstract: Vaginal microbicide gel trials for HIV prevention may require withdrawal of study product when a woman becomes pregnant. We assessed the potential impact of withdrawals in four trials by comparing self-reported sexual behavior pre- and post-pregnancy detection: (1) behavior in the month prior to positive pregnancy test versus behavior reported at the subsequent monthly visit; (2) behavior changes according to pregnancy status at the subsequent visit (continuing pregnancy versus not); (3) average sexual behaviors reported for all months prior to pregnancy detection versus all months after pregnancy was no longer detected; and (4) behavior changes among participants never testing positive for pregnancy. Pregnancy detection was associated with immediate reductions in self-reported numbers of partners and sex acts. The proportion of acts in which study gel was used following a negative pregnancy test did not return to pre-pregnancy levels. Pregnancies complicate the conduct and interpretation of vaginal microbicide trials when product must be withdrawn.
authors.affiliation: Duke Human Vaccine Institute, Duke University, Durham, NC, USA.
authors.forename: Wes
authors.initials: W
authors.lastname: Rountree
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Feldblum
authors.forename: Douglas
authors.initials: D
authors.lastname: Taylor
authors.forename: Silver L
authors.initials: SL
authors.lastname: Wevill
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D011247:Pregnancy; D012307:Risk Factors; D057566:Self Report; D012725:Sexual Behavior / Q000706:statistics & numerical data*; D012747:Sexual Partners; D014622:Vaginal Creams, Foams, and Jellies; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D014622:Vaginal Creams, Foams, and Jellies