BACKGROUND: Microbicide gels studied for HIV prevention often are delivered via a single-use vaginal applicator. Using a contraceptive diaphragm such as the SILCS diaphragm for gel delivery could have advantages, including lower cost and additional pregnancy prevention. STUDY DESIGN: We performed an exploratory, nonblinded, randomized, crossover study among healthy, sexually active, nonpregnant women. Using BufferGel, we evaluated three microbicide delivery methods for gel distribution and retention: SILCS single-sided gel delivery, SILCS double-sided gel delivery and a vaginal applicator (without SILCS). Magnetic resonance images were taken at baseline, after gel insertion, and immediately and 6 h after simulated intercourse. Three women completed all gel delivery methods described in this article. RESULTS: Magnetic resonance imaging analysis indicated similar gel spread in the vagina among all three methods. SILCS single-sided gel application resulted in the most consistent longitudinal coverage; SILCS double-sided gel application was the most consistent in the transverse dimension. CONCLUSIONS:Gel coverage was similar with all three methods. These results suggest that the SILCS microbicide delivery system is comparable to vaginal applicators for delivery of gel products intravaginally.
RCT Entities:
BACKGROUND: Microbicide gels studied for HIV prevention often are delivered via a single-use vaginal applicator. Using a contraceptive diaphragm such as the SILCS diaphragm for gel delivery could have advantages, including lower cost and additional pregnancy prevention. STUDY DESIGN: We performed an exploratory, nonblinded, randomized, crossover study among healthy, sexually active, nonpregnant women. Using BufferGel, we evaluated three microbicide delivery methods for gel distribution and retention: SILCS single-sided gel delivery, SILCS double-sided gel delivery and a vaginal applicator (without SILCS). Magnetic resonance images were taken at baseline, after gel insertion, and immediately and 6 h after simulated intercourse. Three women completed all gel delivery methods described in this article. RESULTS: Magnetic resonance imaging analysis indicated similar gel spread in the vagina among all three methods. SILCS single-sided gel application resulted in the most consistent longitudinal coverage; SILCS double-sided gel application was the most consistent in the transverse dimension. CONCLUSIONS: Gel coverage was similar with all three methods. These results suggest that the SILCS microbicide delivery system is comparable to vaginal applicators for delivery of gel products intravaginally.
Authors: Kurt T Barnhart; E Scott Pretorius; Kelly Timbers; David Shera; Mayadah Shabbout; Daniel Malamud Journal: Contraception Date: 2005-05 Impact factor: 3.375
Authors: K H Mayer; J Peipert; T Fleming; A Fullem; T Moench; S Cu-Uvin; M Bentley; M Chesney; Z Rosenberg Journal: Clin Infect Dis Date: 2001-01-26 Impact factor: 9.079
Authors: Kurt T Barnhart; Michael J Rosenberg; H Trent MacKay; Diana L Blithe; Jim Higgins; Terri Walsh; Livia Wan; Michael Thomas; Mitchell D Creinin; Carolyn Westhoff; William Schlaff; David F Archer; Charletta Ayers; Andrew Kaunitz; Sutapa Das; Thomas R Moench Journal: Obstet Gynecol Date: 2007-09 Impact factor: 7.661
Authors: Jill L Schwartz; Susan A Ballagh; Mitchell D Creinin; Robert W Rountree; Maggie Kilbourne-Brook; Christine K Mauck; Marianne M Callahan Journal: Contraception Date: 2008-07-03 Impact factor: 3.375
Authors: Kurt T Barnhart; Adriana Izquierdo; E Scott Pretorius; David M Shera; Mayadah Shabbout; Alka Shaunik Journal: Hum Reprod Date: 2006-02-14 Impact factor: 6.918
Authors: D'Nyce L Williams; Daniel R Newman; Susan A Ballagh; Mitchell D Creinin; Kurt Barnhart; Debra H Weiner; April J Bell; Denise J Jamieson Journal: Sex Transm Dis Date: 2007-12 Impact factor: 2.830
Authors: Kurt Thomas Barnhart; E Scott Pretorius; Kelly Timbers; David Shera; Mayadah Shabbout; Daniel Malamud Journal: Contraception Date: 2004-12 Impact factor: 3.375