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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.
JMIR Res Protoc. 2019 Apr 23; 8(4):e12205.JR

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://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

DERR1-10.2196/12205.

Authors+Show Affiliations

Rollins School of Public Health, Department of Behavioral Sciences and Health Educaiton, Emory University, Atlanta, GA, United States.University at Albany School of Public Health, Department of Epidemiology, State University of New York, Albany, NY, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.School of Medicine, Emory University, Atlanta, GA, United States.Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, United States.Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, United States.University at Albany School of Public Health, Department of Epidemiology, State University of New York, Albany, NY, United States.TheyFit, LLC, Covington, GA, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31012862

Citation

Siegler, Aaron J., et al. "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." JMIR Research Protocols, vol. 8, no. 4, 2019, pp. e12205.
Siegler AJ, Rosenthal EM, Sullivan PS, et al. 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. JMIR Res Protoc. 2019;8(4):e12205.
Siegler, A. J., Rosenthal, E. M., Sullivan, P. S., Ahlschlager, L., Kelley, C. F., Mehta, C. C., Moore, R. H., Rosenberg, E. S., & Cecil, M. P. (2019). 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. JMIR Research Protocols, 8(4), e12205. https://doi.org/10.2196/12205
Siegler AJ, et al. 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. JMIR Res Protoc. 2019 Apr 23;8(4):e12205. PubMed PMID: 31012862.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Siegler,Aaron J, AU - Rosenthal,Elizabeth M, AU - Sullivan,Patrick S, AU - Ahlschlager,Lauren, AU - Kelley,Colleen F, AU - Mehta,C Christina, AU - Moore,Reneé H, AU - Rosenberg,Eli S, AU - Cecil,Michael P, Y1 - 2019/04/23/ PY - 2018/09/13/received PY - 2019/02/14/accepted PY - 2019/01/04/revised PY - 2019/4/24/entrez PY - 2019/4/24/pubmed PY - 2019/4/24/medline KW - HIV prevention KW - clinical trial KW - condoms KW - sexual health SP - e12205 EP - e12205 JF - JMIR research protocols JO - JMIR Res Protoc VL - 8 IS - 4 N2 - 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://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12205. SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/31012862/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_ L2 - https://www.researchprotocols.org/2019/4/e12205/ DB - PRIME DP - Unbound Medicine ER -