Sex Transm Infect 87:301-305 doi:10.1136/sti.2010.047142
  • Clinical

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

  1. for the MIRA team
  1. 1Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa
  2. 2Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA
  3. 3Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, San Francisco, California, USA
  4. 4Women's Global Health Imperative, RTI International, San Francisco Office, California, USA
  5. 5Ibis Reproductive Health, Cambridge, Massachusetts, USA
  6. 6University of Zimbabwe–UCSF Collaborative Research Programme in Women's Health, Harare, Zimbabwe
  7. 7Medical Research Council, Durban, South Africa
  1. Correspondence to Guy de Bruyn, Perinatal HIV Research Unit, New Nurses Home, Chris Hani Baragwanath Hospital, PO Box 114, Diepkloof, Johannesburg 1864, South Africa; debruyng{at}
  1. Contributors NP, AvdS and SS designed the MIRA trial. GdB, GR and TC were site investigators who oversaw study implementation at trial sites supported by KB and EM. SS was the study statistician and conducted the analyses. All authors contributed to the interpretation of the data and development of the paper. The paper was written by GdB and SS. All other authors reviewed the manuscript and approved the final version.

  • Accepted 2 March 2011
  • Published Online First 29 March 2011


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; number NCT00121459.


  • Funding The MIRA trial was funded through a grant from the Bill and Melinda Gates Foundation (#21082).

  • Competing interests None.

  • Ethics approval The study protocol was reviewed and approved by all participating institutions' ethical review boards.

  • Provenance and peer review Not commissioned; externally peer reviewed.