JMIR Publications

ABSTRACT

Background:

Male condoms are underutilized despite their ability to prevent transmission of HIV and other sexually transmitted infections. The perception of decreased sexual pleasure and poor condom fit are major contributors to condom nonuse.

Objective:

The purpose of this study was to compare event-level performance and pleasure among fitted, thin and standard condoms among MSM and men who sex with women (MSW) and to assess condom type preference. We present the study design and enrollment data from the trial.

Methods:

This study recruited sexually active men aged 18-54 in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms. A permuted block randomization scheme was used to assign each participant to the sequence in which they received each type of study condom. After a baseline screening and enrollment visit, randomized participants were followed for at least 6 and up to 12 weeks depending on their use of study condoms in each two-week period between scheduled, in-person study visits. Participants were instructed to complete mobile-optimized coital logs as soon as possible after using condoms for anal or vaginal sex acts. The logs collected event-level pleasure and performance measures for the study condoms as well as other relevant data. A questionnaire was administered at the final study visit to assess overall study condom preference.

Results:

The study enrolled 252 MSM and 252 MSW, a total of 504 participants. MSM and MSW study arms were similar for a number of key traits including race/ethnicity, marital status, self-rated condom experience, and recent experience of condom failure. Men in the MSM arm were older, however, and fewer MSM were students. The majority of participants in both arms rated themselves as “very experienced” with using condoms, and the majority had used condoms recently. Over one-third of participants in each arm reported experiencing condom failure in the last six months.

Conclusions:

This is the first condom trial to compare the performance of standard, thin and fitted condoms, and to use pleasure and preference as primary outcomes. Given the disparate impact of HIV on MSM, equal enrollment of MSM and MSW was a key feature of this study. Trial results may inform an FDA label indication for anal sex, as well as provide new information regarding the relative performance of different types of condoms. Clinical Trial: ClinicalTrials.gov NCT02753842 (Registered 28th of April 2016)