RT Journal Article
SR Electronic
T1 The effect of the vaginal diaphragm and lubricant gel on acquisition of HSV-2
JF Sexually Transmitted Infections
JO Sex Transm Infect
FD BMJ Publishing Group Ltd
SP 301
OP 305
DO 10.1136/sti.2010.047142
VO 87
IS 4
A1 de Bruyn, Guy
A1 Shiboski, Stephen
A1 van der Straten, Ariane
A1 Blanchard, Kelly
A1 Chipato, Tsungai
A1 Ramjee, Gita
A1 Montgomery, Elizabeth
A1 Padian, Nancy
A1 for the MIRA team
YR 2011
UL http://sti.bmj.com/content/87/4/301.abstract
AB Background In the context of a multisite HIV prevention trial in Southern African women, we examined the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens) and condoms compared to condoms alone on the incidence of herpes simplex virus type 2 (HSV-2) infections.Methods We analysed data from 2016 sexually active women in Zimbabwe and South Africa. Women were followed quarterly, and specimens obtained at the closing visit from previously HSV-2 seronegative women were retested for HSV-2 antibodies using Focus HerpeSelect Elisa. The first visit at which the participant tested positive for HSV-2 was defined by back-testing. We compared the incidence of HSV-2 after randomisation between study arms in both intent-to-treat (ITT) and per-protocol populations.Results 210 women acquired HSV-2 during study participation (HSV incidence: 6.8 cases/100 women years). Allocation to the intervention arm was found to offer no benefit in reduction of HSV-2 by modified ITT (HR 1.03, 95% CI 0.78 to 1.35; p=0.85) or per protocol analysis (HR 0.87, 95% CI 0.61 to 1.24; p=0.45).Conclusions HSV-2 infection was common in the study population as detected by type-specific Elisa testing. Provision of diaphragm and lubricant gel offered no additional protection against HSV-2 acquisition over male condoms alone.Trial Registration http://ClinicalTrials.gov; number NCT00121459.