title: Australian men's experiences during a microbicide male tolerance study.
abstract: Microbicides currently in development have the potential to provide new options for the prevention of sexually transmitted infections if proven safe and efficacious. We examined the experiences of healthy male volunteers in a male tolerance study in Victoria, Australia in relation to trial participation and product use. Men (N=36) enrolled in a seven-day, phase 1 clinical safety trial of SPL7013 were interviewed pre and post-use of the gel using a semi-structured interview guide. Interviews were digitally recorded and transcribed verbatim, and transcripts were analysed using a framework approach. All but one man completed the trial. The median age was 34 years (range 22-67 years). Most men had little pre-study knowledge of microbicides and almost all participated for altruistic or personal reasons. Men expressed few concerns about product safety during the trial and indicated trust in the information received through the consent process and from study staff. Three men were non-adherent to the request to be abstinent and an additional two did not refrain from masturbation. Most were positive about the gel, although they described it as "sticky" and found that it stuck to clothes, bed sheets and pubic hair. The type of applicator used was unfamiliar to the men, and some found it "clinical" in appearance. Men are willing to participate in male tolerance studies, often for altruistic reasons. However, counseling about ways to maintain abstinence and further research to inform anticipatory guidance regarding the "sticky" quality of gels, may be important.
authors.affiliation: Department of Pediatrics and Sealy Center for Vaccine Development, University of Texas Medical Branch at Galveston, Galveston, TX, USA. slrosent@utmb.edu
authors.forename: Susan L
authors.initials: SL
authors.lastname: Rosenthal
authors.forename: Wendy
authors.initials: W
authors.lastname: Holmes
authors.forename: Lisa
authors.initials: L
authors.lastname: Maher
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D008875:Middle Aged; D036301:Qualitative Research; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D011795:Surveys and Questionnaires; D014739:Victoria; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D005782:Gels