title: Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial.
abstract: BACKGROUND
  Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe.
  
  
  METHODS
  We did an open-label, randomised controlled trial in HIV-negative, sexually active women recruited from clinics and community-based organisations, who were followed up quarterly for 12-24 months (median 21 months). All participants received an HIV prevention package consisting of pre-test and post-test counselling about HIV and sexually transmitted infections, testing, treatment of curable sexually transmitted infections, and intensive risk-reduction counselling. The primary outcome was incident HIV infection. This study is registered with ClinicalTrials.gov, number NCT00121459.
  
  
  RESULTS
  Overall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84-1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54%vs 85% of visits, p<0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups.
  
  
  CONCLUSIONS
  We observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were provided in addition to condoms and a comprehensive HIV prevention package. Our observation that lower condom use in women provided with diaphragms did not result in increased infection merits further research. Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies.
authors.affiliation: University of California, San Francisco, CA, USA. Electronic address: npadian@globalhealth.ucsf.edu.
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Padian
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.affiliation: HIV Prevention Research Unit, Medical Research Council, Durban, South Africa.
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.affiliation: University of Zimbabwe, Harare, Zimbabwe.
authors.forename: Tsungai
authors.initials: T
authors.lastname: Chipato
authors.affiliation: Perinatal HIV Research Unit, University of the Witswatersrand, Johannesburg, South Africa.
authors.forename: Guy
authors.initials: G
authors.lastname: de Bruyn
authors.affiliation: Ibis Reproductive Health, Cambridge, MA, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Blanchard
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Shiboski
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Elizabeth T
authors.initials: ET
authors.lastname: Montgomery
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Heidi
authors.initials: H
authors.lastname: Fancher
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Helen
authors.initials: H
authors.lastname: Cheng
authors.affiliation: University of California, Berkeley, CA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Rosenblum
authors.affiliation: University of California, Berkeley, CA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: van der Laan
authors.affiliation: University of California, Berkeley, CA, USA.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Jewell
authors.affiliation: Perinatal HIV Research Unit, University of the Witswatersrand, Johannesburg, South Africa.
authors.forename: James
authors.initials: J
authors.lastname: McIntyre
mesh_terms: D000293:Adolescent; D000328:Adult; D017280:Condoms / Q000706:statistics & numerical data; D003274:Contraceptive Devices, Female; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D013019:South Africa / Q000453:epidemiology; D014622:Vaginal Creams, Foams, and Jellies; D015030:Zimbabwe / Q000453:epidemiology
chemical_list: D014622:Vaginal Creams, Foams, and Jellies