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| Name | Class |
|---|---|
| Emory University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Pleasure Scale Score for Thin Versus Standard Condoms | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron J Siegler, PhD | Emory University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31012862 | Background | 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. | |
| 31891134 |
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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.
Participants were recruited in Atlanta, GA from May 19, 2016 - May 2, 2017. Recruitment was predominantly through electronic advertising and paper signs posted at venues such as college campuses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fitted, Then Thin, Then 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. |
| FG001 | Fitted, Then Standard, Then Thin 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. |
| FG002 | Thin, Then Fitted, Then 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. |
| FG003 | Thin, Then Standard, Then Fitted 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. |
| FG004 | Standard, Then Fitted, Then Thin 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. |
| FG005 | Standard, Then Thin, Then Fitted 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Follow-Up (Set of Condoms) |
| |||||||||||||
| Second Follow-Up (Set of Condoms) |
| |||||||||||||
| Third Follow-Up (Set of Condoms) |
|
All participants completed baseline data collection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fitted, Then Thin, Then Standard Condoms | Fitted, Then Thin, Then Standard Condoms. |
| BG001 | Fitted, Then Standard, Then Thin Condoms | Fitted, Then Standard, Then Thin Condoms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis is comprised of pleasure scale scores completed after each sex act, when a study condom was used. | Posted | Mean | Standard Error | score on a scale | Up to 12 weeks | Sex acts with study condoms | Sex acts with study condoms |
|
The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fitted Condoms | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic STI or recent STI diagnosis | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Siegler | Emory University | 404-712-9733 | asiegle@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2016 | Jul 20, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2016 | Jul 20, 2020 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2019 | Jul 20, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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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.
| 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. |
|
| 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. |
|
|
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 |
| Up to 12 weeks |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Thin, Then Fitted, Then Standard Condoms | Thin, Then Fitted, Then Standard Condoms. |
| BG003 | Thin, Then Standard, Then Fitted Condoms | Thin, Then Standard, Then Fitted Condoms. |
| BG004 | Standard, Then Fitted, Then Thin Condoms | Standard, Then Fitted, Then Thin Condoms. |
| BG005 | Standard, Then Thin, Then Fitted Condoms | Standard, Then Thin, Then Fitted Condoms. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Fitted Condoms |
Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization. |
| OG001 | Standard Condoms | Participants will receive all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization. |
|
|
|
| Primary | 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. | Participants who used at least one fitted and one standard condom | Posted | Number | 95% Confidence Interval | % of participants prefer fitted condoms | Up to 12 weeks |
|
|
|
|
| Primary | 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. | Participants who used at least one condom during the study | Posted | Count of Units | Condoms | Up to 12 weeks | Condoms | Condoms |
|
|
|
| Primary | 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. | Persons contributing data regarding performance of at least one condom in the condition. | Posted | Count of Units | Condoms | Up to 12 weeks | Condoms | Condoms |
|
|
|
|
| Secondary | Sexual Pleasure Scale Score for Thin Versus Standard Condoms | 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. | The analysis is comprised of pleasure scale scores completed after each sex act, when a study condom was used. | Posted | Mean | Standard Error | score on a scale | Up to 12 weeks | Sex acts with study condoms | Sex acts with study condoms |
|
|
|
|
| 0 |
| 468 |
| 0 |
| 468 |
| 9 |
| 468 |
| EG001 | Thin Condoms | 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. | 0 | 469 | 0 | 469 | 11 | 469 |
| EG002 | Standard Condoms | 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. | 0 | 464 | 0 | 464 | 6 | 464 |
| Condom- or lube-related discomfort | Investigations | Systematic Assessment |
|
| Partner discomfort with lubricant | Investigations | Non-systematic Assessment |
|
| Partner Urinary Tract Infection | Investigations | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |