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.

Keywords:

• topical microbicides
• sexuality
• sexually transmitted infections
• male tolerance studies
• clinical trial participation

Acknowledgements

The authors would like to acknowledge Marcus Chen, Principal Investigator of the male tolerance study; Laura Clark, Mary Poynten, Iona Millwood for contribution to the design and coordination of the clinical trial; David Wain, Kirk Peterson for conduct of interviews and liaison with participants; Julie Silvers, Fiona MacFarlane, and other clinic staff at Melbourne Sexual Health Centre for recruitment and management of participants and data; Melissa Loza and Megan Elbon for help with data organization; and most importantly, the participants for giving their time and sharing their experiences. This study was funded with US Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN266200500042C to Starpharma Pty Ltd. Susan Rosenthal is supported by a grant from the National Institute of Child Health and Human Development of the National Institutes of Health (R01 HD40151-01). Lisa Maher is supported by a National Health and Medical Research Council Career (NHMRC) Development Award. The National Centre in HIV Epidemiology and Clinical Research is core funded by the Australian Government Department of Health and Ageing.