Clinical trial NCT02753842: Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
Official title: A Double-Blind, Single Center, Randomized 3-way Crossover Trial to Determine Pleasure for Fitted, Thin and Standard Condoms, and to Assess Clinical Failure for Vaginal and Anal Sex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Sexually Transmitted Infections
Condoms
Contraceptive Devices
HIV
Lead sponsor: Global Protection Corp.
Sponsor class: INDUSTRY
Collaborators: name: Emory University
First posted: 2016-04-28
Enrollment: 504
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We recruited 504 participants into the crossover trial. Participants were randomized into one of six sequences, each representing the order in which a participant would receive batches of five study condoms of a particular type.
Primary purpose: PREVENTION

Brief summary: This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with women (MSW) in a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms. The study will provide fitted condoms in 56 sizes based on combinations of length (approximately 10 mm increments) and circumference (approximately 2 mm increments), with user-determined size based on a paper template measurement instrument.

Participants will be randomly assigned to the sequence in which the crossover intervention conditions (fitted, thin, and standard condoms) occur, with five study condoms provided for each condition. Participants will attend at least four, and up to seven, biweekly study visits.

Detailed description: Study objectives are to establish label indications for pleasure and patient preference for fitted condoms, establish label indication for anal sex for fitted, thin, and standard condoms, and establish a label indication for decreased clinical failure of fitted condoms for anal sex.

The study will enroll 252 MSM and 252 men who sex with women (MSW) into a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms. For MSM enrolled in the trial we will assess outcomes based on anal sex, and for MSW we will assess outcomes based on vaginal sex. The study will provide fitted condoms in 56 sizes based on combinations of length (approximately 10 mm increments) and circumference (approximately 2 mm increments), with user-determined size based on a paper template measurement instrument.

For purposes of this study, a "standard" condom is defined by dimensions commonly sourced by the United Nations Population Fund (UNFPA) and United States Agency for International Development (USAID), which procures the majority of the world's condoms. These dimensions are 185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. "Thin" condoms for this study will be of identical width and length to "standard", but 50 microns ± 5 microns thick. Fitted condoms will be produced in a range of sizes with thickness of 70 microns ± 10 microns, with a participant's fitted size as determined by their use of a fitting system consisting of a paper template graduated with non-sequential numbering and lettering. Condoms will be manufactured using the same latex formulation and silicone lubricants (approximately 400mg per condom), and with similar parallel wall designs.

Every participant in the trial will receive a set of five fitted condoms (fitted condition), a set of five thin condoms (thin condition), and a set of five standard condoms (standard condition) over a series of study visits. Event-level data based on a home coital log will be collected regarding pleasure and total clinical failure, and data regarding overall condom preference will be collected at the final study visit. Participants will be randomly assigned to the sequence in which the crossover intervention conditions (fitted, thin, and standard) occur. Each participant will attend at least four, and up to seven, biweekly study visits. Participants will be given up to four weeks to use each study condom set; after 4 weeks with a set of condoms, participants will be automatically crossed over into the next study condition. If all condoms are used within the first two weeks, participants will crossover to the next randomized condition.

Participants will be blinded, with all condoms produced in plain foils with two-digit identifying codes, and role-based blinding will be conducted for study staff with the statistician and PI blinded. Participants will be trained in appropriate condom use, fitted condom sizing, study instructions such as only using study lubricant, and daily coital log completion. Participants will complete mobile-optimized, web-based home coital logs as soon as possible following any vaginal or anal sex acts. To assist participants in timely completion, there will be a daily check-in through Short Message Service (SMS) (via text message) with a reminder initiated if no sexual event has been recently reported. The coital log will include outcome measures for pleasure and for condom failure. The final visit survey will measure overall condom preference.

Eligibility criteria: Inclusion Criteria:

* Lives in or near Atlanta metropolitan statistical area (MSA)
* Plans to be in Atlanta for the majority of the 12 weeks of enrollment
* Able to independently complete survey instruments in English
* Male sex at birth
* Currently identifies as male
* For MSM, self-report to have only had sex with men in the past four weeks
* For MSM, self-report intends to have sex only with men in the next 12 weeks
* For MSW, self-report to have only had sex with women in the past four weeks
* For MSW, self-report intends to have sex only with women in the next 12 weeks
* Self-report at least 1 anal (MSM) or vaginal (MSW) sex act in the past four weeks
* For MSM, self-reports an insertive role in the past four weeks
* Willing and able to have sex using a latex condom provided by study
* Consistently able to maintain an erection while using condoms
* Willing to provide at least two means of contact
* Willing to only use lubricant provided by study
* Willing to use a fitting tool to determine penile dimensions

Exclusion Criteria:

* Self-report transgender sex partners in the past four weeks
* Plans to not have sex in the next four weeks
* For MSW, report that current partner is currently pregnant
* For MSW, report that current partner desires to become pregnant currently or in the next 12 weeks
* Allergic to latex
* Current partner(s) allergic to latex
* Genital piercings
* For MSW, female current partner(s) has (have) vaginal piercings
* For MSM, male current partner(s) has (have) anal piercings
* Current partner(s) known to be HIV-positive
* Self-report presence of sexually transmitted infections, including HIV
* Confirmed HIV positive at baseline
* Allergic to water-based lubricant
* Current partner(s) allergic to water-based lubricant

Primary outcomes:
measure: Sexual Pleasure Scale Score for Fitted Versus Standard Condoms
timeFrame: Up to 12 weeks
measure: Percent of Participants Preferring Fitted Condoms to Standard Condoms
timeFrame: Up to 12 weeks
measure: Clinical Condom Failure for Anal Sex
timeFrame: Up to 12 weeks
measure: Clinical Condom Failure of Fitted Condoms Compared to Standard Condoms for Anal Sex
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Sexual Pleasure Scale Score for Thin Versus Standard Condoms
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Aaron J Siegler, PhD
role: STUDY_DIRECTOR
References:
citation: Siegler AJ, Rosenthal EM, Sullivan PS, Ahlschlager L, Kelley CF, Mehta CC, Moore RH, Rosenberg ES, Cecil MP. 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. doi: 10.2196/12205.
citation: Siegler AJ, Rosenthal EM, Sullivan PS, Christina Mehta C, Moore RH, Ahlschlager L, Kelley CF, Rosenberg ES, Cecil MP. Levels of clinical condom failure for anal sex: A randomized cross-over trial. EClinicalMedicine. 2019 Oct 31;17:100199. doi: 10.1016/j.eclinm.2019.10.012. eCollection 2019 Dec.