Condom Performance in a Longitudinal Enhanced Assessment of User Experiences

NCT02753842 | Completed Results FDA Device

• 1 other identifier: IRB00083754
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV

Keywords

Sexually Transmitted Infections; Condoms; Contraceptive Devices; HIV

Outcome Measures

Primary Outcomes (4)

• Sexual Pleasure Scale Score for Fitted Versus Standard Condoms

  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.

  Up to 12 weeks

• Percent of Participants Preferring Fitted Condoms to Standard Condoms

  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.

  Up to 12 weeks

• Clinical Condom Failure for Anal Sex

  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.

  Up to 12 weeks

• Clinical Condom Failure of Fitted Condoms Compared to Standard Condoms for Anal Sex

  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.

  Up to 12 weeks

Secondary Outcomes (1)

• Sexual Pleasure Scale Score for Thin Versus Standard Condoms

  Up to 12 weeks

Study Arms (6)

Fitted, Then Thin, Then Standard Condoms

EXPERIMENTAL

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.

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

Fitted, Then Standard, Then Thin Condoms

EXPERIMENTAL

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.

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

Thin, Then Fitted, Then Standard Condoms

EXPERIMENTAL

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.

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

Thin, Then Standard, Then Fitted Condoms

EXPERIMENTAL

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.

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

Standard, Then Fitted, Then Thin Condoms

EXPERIMENTAL

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.

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

Standard, Then Thin, Then Fitted Condoms

EXPERIMENTAL

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.

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

Interventions

5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms DEVICE

Fitted condoms are available in 56 sizes based on combinations of length (approximately 10mm increments) and circumference (approximately 2 mm increments). Fitted condom thickness is 70 microns ± 10 microns. Appropriate condom size is user-determined with a paper template fitting tool graduated with non-sequential numbering and lettering for maximum privacy. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant. Thin condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 50 microns ± 5 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant. Standard condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.

Fitted, Then Standard, Then Thin Condoms; Fitted, Then Thin, Then Standard Condoms; Standard, Then Fitted, Then Thin Condoms; Standard, Then Thin, Then Fitted Condoms; Thin, Then Fitted, Then Standard Condoms; Thin, Then Standard, Then Fitted Condoms

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Global Protection Corp.: lead
• Emory University: collaborator

Related Publications (2)

• 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.

  PMID: 31012862 BACKGROUND

• 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.

  PMID: 31891134 RESULT

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Aaron Siegler
• Organization: Emory University

asiegle@emory.edu

404-712-9733

Study Officials

• Aaron J Siegler, PhD

  Emory University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this closed label trial, study condoms were manufactured in plain foil packaging with identifying 2-digit random codes printed on each foil. Blinding of study staff was role-based; the study statistician and the principal investigator were blinded. To allow for blinded participants to identify preferred condoms, we provided condom sets in color-coded bags. We selected colors that could accommodate common forms of color vision deficiency.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: May 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 25, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-08