Condom Performance in a Longitudinal Enhanced Assessment of User Experiences

Not Applicable

Completed

Conditions: HIV

Interventions: Device: 5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms

Registration Number: NCT02753842

Lead Sponsor: Global Protection Corp.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 504

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fitted, Then Standard, Then Thin Condoms	5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms	Participants first received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them.
Fitted, Then Thin, Then Standard Condoms	5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms	Participants first received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them.
Thin, Then Fitted, Then Standard Condoms	5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms	Participants first received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them.
Thin, Then Standard, Then Fitted Condoms	5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms	Participants first received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them.
Standard, Then Fitted, Then Thin Condoms	5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms	Participants first received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them.
Standard, Then Thin, Then Fitted Condoms	5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms	Participants first received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them.

Primary Outcome Measures

Name	Time	Method
Percent of Participants Preferring Fitted Condoms to Standard Condoms	Up to 12 weeks	Our aim was to compare fitted condoms with standard condoms regarding preference, as determined by ranking of the two conditions at the study conclusion. Condom preference was determined by participants selecting a preference for fitted or standard condoms at the study conclusion. The measure used assessed a blinded preference, referring to the color assigned to the condom type rather than the type of condom by name.
Clinical Condom Failure of Fitted Condoms Compared to Standard Condoms for Anal Sex	Up to 12 weeks	Our aim was to compare fitted condoms with standard condoms regarding total clinical failure for anal sex among MSM. Clinical condom failure (condom breakage and slippage) was assessed based on questions suggested by the International Organization for Standardization (ISO) and with a mobile-optimized, web-based home daily coital log completed following each coital event. Clinical failure was calculated according to ISO guidance.
Sexual Pleasure Scale Score for Fitted Versus Standard Condoms	Up to 12 weeks	Our aim was to compare fitted condoms with standard condoms regarding levels of reported pleasure, as determined by rating per condom use event. The sexual pleasure scale for this study was developed and validated by the study team (Siegler et. al., Arch Sex Behav. 2018 Aug; 47(6): 1745-1754), and is titled event-level, male sexual pleasure scale (EMSEXpleasure). The scale comprises 11 items with sliding scale response scores. Pleasure scale measurement was assessed with a mobile-optimized, web-based home daily coital log, completed following each coital event. The minimum scale score was zero, the maximum was 100. Higher values indicate greater pleasure. We assessed the difference in mean scores of pleasure for fitted condoms versus standard condoms.
Clinical Condom Failure for Anal Sex	Up to 12 weeks	Our aim was to assess for fitted, thin, and standard condoms the total clinical failure rate of each type of condom for anal sex among MSM relative to the 5% failure cut-point previously used by the United States Food and Drug Administration (FDA). Clinical condom failure (condom breakage and slippage) was assessed by questions from the International Organization for Standardization (ISO), with a mobile-optimized, web-based home daily coital log completed following each coital event. Clinical failure was calculated according to ISO guidance.

Secondary Outcome Measures

Name	Time	Method
Sexual Pleasure Scale Score for Thin Versus Standard Condoms	Up to 12 weeks	This secondary outcome sought to compare thin condoms with standard condoms regarding levels of reported pleasure, as determined by rating per condom use event. The sexual pleasure scale for this study was developed and validated by the study team (Siegler et. al., Arch Sex Behav. 2018 Aug; 47(6): 1745-1754), and is titled event-level, male sexual pleasure scale (EMSEXpleasure). The scale comprises 11 items with sliding scale response scores. Pleasure scale measurement was assessed with a mobile-optimized, web-based home daily coital log, completed following each coital event. The minimum scale score was zero, the maximum was 100. Higher values indicate greater pleasure. We assessed the difference in mean scores of pleasure for thin condoms versus standard condoms.