HIV
Conditions
Keywords
Sexually Transmitted Infections, Condoms, Contraceptive Devices, HIV
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.
Interventions
DEVICE5 Fitted Condoms, 5 Thin Condoms, 5 Standard 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. 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.
Sponsors
Emory University
Global Protection Corp.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 54 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
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.
Pre-assignment 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.
Participants by arm
| Arm | Count |
|---|---|
| Fitted, Then Thin, Then Standard Condoms Fitted, Then Thin, Then Standard Condoms. | 85 |
| Fitted, Then Standard, Then Thin Condoms Fitted, Then Standard, Then Thin Condoms. | 84 |
| Thin, Then Fitted, Then Standard Condoms Thin, Then Fitted, Then Standard Condoms. | 85 |
| Thin, Then Standard, Then Fitted Condoms Thin, Then Standard, Then Fitted Condoms. | 83 |
| Standard, Then Fitted, Then Thin Condoms Standard, Then Fitted, Then Thin Condoms. | 83 |
| Standard, Then Thin, Then Fitted Condoms Standard, Then Thin, Then Fitted Condoms. | 84 |
| Total | 504 |
Baseline characteristics
| Characteristic | Fitted, Then Thin, Then Standard Condoms | Fitted, Then Standard, Then Thin Condoms | Thin, Then Fitted, Then Standard Condoms | Thin, Then Standard, Then Fitted Condoms | Standard, Then Fitted, Then Thin Condoms | Standard, Then Thin, Then Fitted Condoms | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 20-24 years | 28 Participants | 25 Participants | 29 Participants | 29 Participants | 21 Participants | 26 Participants | 158 Participants |
| Age, Customized < 20 years | 9 Participants | 11 Participants | 9 Participants | 8 Participants | 15 Participants | 4 Participants | 56 Participants |
| Age, Customized 25-29 years | 16 Participants | 19 Participants | 22 Participants | 20 Participants | 24 Participants | 22 Participants | 123 Participants |
| Age, Customized 30-39 years | 23 Participants | 20 Participants | 16 Participants | 19 Participants | 15 Participants | 15 Participants | 108 Participants |
| Age, Customized 40-54 years | 9 Participants | 9 Participants | 9 Participants | 7 Participants | 8 Participants | 17 Participants | 59 Participants |
| Race/Ethnicity, Customized African-American non-Hispanic | 18 Participants | 23 Participants | 19 Participants | 25 Participants | 23 Participants | 23 Participants | 131 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 13 Participants | 12 Participants | 11 Participants | 6 Participants | 13 Participants | 62 Participants |
| Race/Ethnicity, Customized Other non-Hispanic | 15 Participants | 8 Participants | 10 Participants | 14 Participants | 14 Participants | 8 Participants | 69 Participants |
| Race/Ethnicity, Customized Prefer not to answer, non-Hispanic | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 45 Participants | 40 Participants | 44 Participants | 32 Participants | 40 Participants | 40 Participants | 241 Participants |
| Region of Enrollment United States | 85 participants | 84 participants | 85 participants | 83 participants | 83 participants | 84 participants | 504 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 85 Participants | 84 Participants | 85 Participants | 83 Participants | 83 Participants | 84 Participants | 504 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 468 | 0 / 469 | 0 / 464 |
| other Total, other adverse events | 9 / 468 | 11 / 469 | 6 / 464 |
| serious Total, serious adverse events | 0 / 468 | 0 / 469 | 0 / 464 |
Outcome results
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.
Time frame: Up to 12 weeks
Population: Participants who used at least one condom during the study
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Fitted Condoms | Clinical Condom Failure for Anal Sex | 5 Condoms |
| Standard Condoms | Clinical Condom Failure for Anal Sex | 6 Condoms |
| Standard Condoms | Clinical Condom Failure for Anal Sex | 5 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.
Time frame: Up to 12 weeks
Population: Persons contributing data regarding performance of at least one condom in the condition.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Fitted Condoms | Clinical Condom Failure of Fitted Condoms Compared to Standard Condoms for Anal Sex | 5 Condoms |
| Standard Condoms | Clinical Condom Failure of Fitted Condoms Compared to Standard Condoms for Anal Sex | 5 Condoms |
Comparison: We assessed clinical condom failure for anal sex, comparing anal sex acts with fitted condoms to anal sex acts with standard condoms.p-value: >0.0595% CI: [0.27, 3.24]logistic mixed effects model
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.
Time frame: Up to 12 weeks
Population: Participants who used at least one fitted and one standard condom
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fitted Condoms | Percent of Participants Preferring Fitted Condoms to Standard Condoms | 53.0 % of participants prefer fitted condoms |
Comparison: A single item assessed whether participants preferred fitted condoms or standard condoms at the end of the study (the item word viewed by participants used the blinded identifiers of each condom type).p-value: >0.0595% CI: [0.92, 1.38]Mixed Models Analysis
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.
Time frame: Up to 12 weeks
Population: The analysis is comprised of pleasure scale scores completed after each sex act, when a study condom was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitted Condoms | Sexual Pleasure Scale Score for Fitted Versus Standard Condoms | 71.52 score on a scale | Standard Error 0.77 |
| Standard Condoms | Sexual Pleasure Scale Score for Fitted Versus Standard Condoms | 70.13 score on a scale | Standard Error 0.78 |
Comparison: Comparing fitted to standard condoms, the null hypothesis was no difference in pleasure.p-value: <0.0595% CI: [0.52, 2.26]Mixed Models Analysis
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.
Time frame: Up to 12 weeks
Population: The analysis is comprised of pleasure scale scores completed after each sex act, when a study condom was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitted Condoms | Sexual Pleasure Scale Score for Thin Versus Standard Condoms | 71.19 score on a scale | Standard Error 0.77 |
| Standard Condoms | Sexual Pleasure Scale Score for Thin Versus Standard Condoms | 70.13 score on a scale | Standard Error 0.78 |
Comparison: Comparing thin to standard condoms, the null hypothesis was no difference in pleasure.p-value: <0.0595% CI: [0.18, 1.94]Mixed Models Analysis