title: 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: Perinatal HIV Research Unit, New Nurses Home, Chris Hani Baragwanath Hospital, P.O. Box 114, Diepkloof, Johannesburg 1864, South Africa. debruyng@phru.co.za
authors: Guy
authors: G
authors: de Bruyn
authors: Stephen
authors: S
authors: Shiboski
authors: Ariane
authors: A
authors: van der Straten
authors: Kelly
authors: K
authors: Blanchard
authors: Tsungai
authors: T
authors: Chipato
authors: Gita
authors: G
authors: Ramjee
authors: Elizabeth
authors: E
authors: Montgomery
authors: Nancy
authors: N
authors: Padian
mesh_terms: D000293:Adolescent; D000328:Adult; D017280:Condoms / Q000706:statistics & numerical data; D003274:Contraceptive Devices, Female; D005260:Female; D006558:Herpes Genitalis / Q000517:prevention & control*; D018258:Herpesvirus 2, Human; D006801:Humans; D008055:Lipids / Q000008:administration & dosage; D054327:Lubricants / Q000008:administration & dosage*; D008875:Middle Aged; D012747:Sexual Partners; D013019:South Africa; D055815:Young Adult; D015030:Zimbabwe
chemical_list: D008055:Lipids; D054327:Lubricants; C085472:Replens