title: Rectal-specific microbicide applicator: evaluation and comparison with a vaginal applicator used rectally.
abstract: An applicator designed for rectal delivery of microbicides was tested for acceptability by 95 young men who have sex with men, who self-administered 4 mL of placebo gel prior to receptive anal intercourse over 90 days. Subsequently, 24 of the participants self-administered rectally 4 mL of tenofovir or placebo gel over 7 days using a vaginal applicator, and compared both applicators on a Likert scale of 1-10, with 10 the highest rating. Participants reported high likelihood to use either applicator in the future (mean scores 9.3 and 8.8 respectively, p = ns). Those who tested both liked the vaginal applicator significantly more than the rectal applicator (7.8 vs. 5.2, p = 0.003). Improvements in portability, conspicuousness, aesthetics, tip comfort, product assembly and packaging were suggested for both. This rectal-specific applicator was not superior to a vaginal applicator. While likelihood of future use is reportedly high, factors that decrease acceptability may erode product use over time in clinical trials. Further attention is needed to develop user-friendly, quick-acting rectal microbicide delivery systems.
authors.affiliation: HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, Unit 15, 1051 Riverside Drive, New York, NY, 10032, USA, ac72@columbia.edu.
authors.forename: Alex
authors.initials: A
authors.lastname: Carballo-Diéguez
authors.forename: Rebecca
authors.initials: R
authors.lastname: Giguere
authors.forename: Curtis
authors.initials: C
authors.lastname: Dolezal
authors.forename: José
authors.initials: J
authors.lastname: Bauermeister
authors.forename: Cheng-Shiun
authors.initials: CS
authors.lastname: Leu
authors.forename: Juan
authors.initials: J
authors.lastname: Valladares
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Rohan
authors.forename: Peter A
authors.initials: PA
authors.lastname: Anton
authors.forename: Ross D
authors.initials: RD
authors.lastname: Cranston
authors.forename: Irma
authors.initials: I
authors.lastname: Febo
authors.forename: Kenneth
authors.initials: K
authors.lastname: Mayer
authors.forename: Ian
authors.initials: I
authors.lastname: McGowan
mesh_terms: D000282:Administration, Intravaginal; D000285:Administration, Rectal; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D001900:Boston; D016503:Drug Delivery Systems / Q000295:instrumentation* / Q000379:methods; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control*; D018451:Homosexuality, Male; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D010414:Pennsylvania; D011647:Puerto Rico; D036301:Qualitative Research; D012959:Socioeconomic Factors
chemical_list: D000891:Anti-Infective Agents, Local; D005782:Gels