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.
RCT Entities:
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: Andrew Mujugira; Amalia S Magaret; Connie Celum; Jared M Baeten; Jairam R Lingappa; Rhoda Ashley Morrow; Kenneth H Fife; Sinead Delany-Moretlwe; Guy de Bruyn; Elizabeth A Bukusi; Etienne Karita; Saidi Kapiga; Lawrence Corey; Anna Wald Journal: J Infect Dis Date: 2013-07-30 Impact factor: 5.226
Authors: Andrea Szöllősi; Tímea Raffai; Anita Bogdanov; Valéria Endrész; László Párducz; Ferenc Somogyvári; László Janovák; Katalin Burián; Dezső P Virok Journal: BMC Res Notes Date: 2020-01-31