Double-Blind, Single-Center, Randomized Three-Way Crossover Trial of Fitted, Thin, and Standard Condoms for Vaginal and Anal Sex: C-PLEASURE Study Protocol and Baseline Data

Abstract

Background: Male condoms are underused 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 using fitted, thin, and standard condoms among men who have sex with men (MSM) and men who have sex with women (MSW). We also sought 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 to 54 years in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, 3-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 2-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 and 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 6 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 and provide new information regarding the relative performance of different types of condoms.

Trial registration: ClinicalTrials.gov NCT02753842; https://ichgcp.net/clinical-trials-registry/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0).

International registered report identifier (irrid): DERR1-10.2196/12205.

Keywords: HIV prevention; clinical trial; condoms; sexual health.

Conflict of interest statement

Conflicts of Interest: AJS, EMR, PSS, LA, CFK, CCM, RHM, and ESR have no conflicts of interest to declare. MPC is the owner of TheyFit LLC. On January 26, 2016, TheyFit LLC sold all assets pertaining to the study aims including trademarks, intellectual property, inventory, website, and regulatory approvals to Karex Berhad. MPC has no financial interest in Karex Berhad.

©Aaron J Siegler, Elizabeth M Rosenthal, Patrick S Sullivan, Lauren Ahlschlager, Colleen F Kelley, C Christina Mehta, Reneé H Moore, Eli S Rosenberg, Michael P Cecil. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 23.04.2019.

Figures

Figure 1

Study visit flowchart.

Figure 2

Baseline visit structure.