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The effect of the vaginal diaphragm and lubricant gel on acquisition of HSV-2.

Author(s): de Bruyn G, Shiboski S, van der Straten A, Blanchard K, Chipato T, Ramjee G, Montgomery E, Padian N

Affiliation(s): Perinatal HIV Research Unit, New Nurses Home, Chris Hani Baragwanath Hospital, P.O. Box 114, Diepkloof, Johannesburg 1864, South Africa. debruyng@phru.co.za

Publication date & source: 2011-06, Sex Transm Infect., 87(4):301-5. Epub 2011 Mar 29.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

Page last updated: 2011-12-09

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