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

Abstract

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.

• Authors: Guy de Bruyn, Stephen Shiboski, Ariane van der Straten, Kelly Blanchard, Tsungai Chipato, Gita Ramjee, Elizabeth Montgomery, Nancy Padian, MIRA Team
• Journal: Sexually transmitted infections (Sex Transm Infect) Vol. 87 Issue 4 Pg. 301-5 (Jun 2011) ISSN: 1472-3263 [Electronic] England
• PMID: 21447515 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Lipids
• Lubricants
• Replens

Topics

• Adolescent
• Adult
• Condoms (statistics & numerical data)
• Contraceptive Devices, Female
• Female
• Herpes Genitalis (prevention & control)
• Herpesvirus 2, Human
• Humans
• Lipids (administration & dosage)
• Lubricants (administration & dosage)
• Middle Aged
• Sexual Partners
• South Africa
• Young Adult
• Zimbabwe