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BACKGROUND High pregnancy rates undermine the conduct and interpretation of HIV prevention trials. We performed this analysis to identify baseline participant characteristics associated with increased risk of pregnancy in recent vaginal microbicide trials. STUDY DESIGN We analyzed the data from four recently completed Phase III trials of candidate(More)
BACKGROUND The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk. METHODOLOGY/PRINCIPAL FINDINGS This was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly follow-up visits for HIV(More)
OBJECTIVE To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya. METHODS We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six(More)
We describe cumulative pregnancy probabilities among women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N = 1492). We interviewed the women or relatives in 1991-93 and 1994-96, and reviewed hospital records. Mean follow-up was 9.6 years (median 9 years). We recorded 120 pregnancies, including 40 that went to term or(More)
BACKGROUND Analyzing pooled data from 4 recent microbicide trials, we aimed to determine characteristics of participants at higher risk of HIV and sexually transmitted infections (STIs), to inform targeted recruitment, preserved study power, and potentially smaller study sizes in future trials. METHODS We evaluated the relationships between participants'(More)
This pilot study aimed to determine the feasibility of a larger study of contraception and risk of HIV infection in women. We also measured risk factors for and occurrence of HIV infection in the participants. A cohort of 1537 seronegative women attending a family planning clinic in Nairobi, Kenya was enrolled and followed for up to 12 months per woman. HIV(More)
OBJECTIVES To measure the association between spermicide use and HIV infection, adjusting for condom use, and to measure the association between condom use and HIV infection, adjusting for spermicide use. DESIGN Prospective study of women using nonoxynol-9 (N-9) spermicides and latex condoms, with up to 12 monthly clinic visits for interviews,(More)
BACKGROUND Little is known about pregnancy rates among sex workers (SWs) or the factors that predispose SWs to this risk. We aimed to estimate the pregnancy incidence rate among Madagascar SWs participating in an intervention trial promoting use of male and female condoms and assess the influence of various predictive factors on pregnancy risk. METHODS(More)
BACKGROUND Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall(More)