Australian men's experiences during a microbicide male tolerance study

Area of Science:

• Sexual health research
• Clinical trial safety and efficacy

Background:

• Microbicides offer potential new options for preventing sexually transmitted infections.
• Male tolerance studies are crucial for evaluating the safety and efficacy of these products.

Purpose of the Study:

• To examine the experiences of healthy male volunteers in a phase 1 clinical safety trial of the microbicide SPL7013 gel.
• To assess participant adherence, product usability, and overall acceptance of the microbicide gel.

Main Methods:

• A seven-day, phase 1 clinical safety trial involving 36 healthy male volunteers in Victoria, Australia.
• Semi-structured interviews were conducted pre- and post-product use, with recordings transcribed and analyzed using a framework approach.

Main Results:

• Most participants (N=36) had limited prior knowledge of microbicides and joined the trial for altruistic or personal reasons.
• Participants expressed few safety concerns and trusted study information; however, some adherence issues (abstinence, masturbation) were noted.
• The gel was generally viewed positively but described as "sticky," adhering to clothing and hair. Applicator design was also a point of unfamiliarity and perceived as "clinical."

Conclusions:

• Healthy men are willing to participate in microbicide tolerance studies, often motivated by altruism.
• Further research and counseling are needed to address adherence challenges and the physical properties of microbicide gels, such as stickiness.
• Improvements in product formulation and applicator design may enhance user experience and adherence in future microbicide trials.