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Male condoms are underused despite their ability to prevent transmission of HIV and other sexually transmitted infections. The perception of decreased sexual pleasure and poor condom fit are major contributors to condom nonuse.
The purpose of this study was to compare event-level performance and pleasure using fitted, thin, and standard condoms among men who have sex with men (MSM) and men who have sex with women (MSW). We also sought to assess condom type preference. We present the study design and enrollment data from the trial.
This study recruited sexually active men aged 18 to 54 years in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, 3-way randomized crossover trial with conditions of fitted, thin, and standard condoms. A permuted block randomization scheme was used to assign each participant to the sequence in which they received each type of study condom. After a baseline screening and enrollment visit, randomized participants were followed for at least 6 and up to 12 weeks depending on their use of study condoms in each 2-week period between scheduled, in-person study visits. Participants were instructed to complete mobile-optimized coital logs as soon as possible after using condoms for anal or vaginal sex acts. The logs collected event-level pleasure and performance measures for the study condoms as well as other relevant data. A questionnaire was administered at the final study visit to assess overall study condom preference.
The study enrolled 252 MSM and 252 MSW, a total of 504 participants. MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure. Men in the MSM arm were older, however, and fewer MSM were students. The majority of participants in both arms rated themselves as very experienced with using condoms, and the majority had used condoms recently. Over one-third of participants in each arm reported experiencing condom failure in the last 6 months.
This is the first condom trial to compare the performance of standard, thin, and fitted condoms and to use pleasure and preference as primary outcomes. Given the disparate impact of HIV on MSM, equal enrollment of MSM and MSW was a key feature of this study. Trial results may inform an FDA label indication for anal sex and provide new information regarding the relative performance of different types of condoms.
ClinicalTrials.gov NCT02753842; https://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0)
DERR1-10.2196/12205
Male condoms effectively prevent HIV and sexually transmitted disease (STD) transmission but are underused in large part due to perceived reductions in the experience of pleasure. In the United States, diagnosis of chlamydia, gonorrhea, and syphilis has increased in each of the last 4 years, with approximately 2.3 million diagnoses in 2017 [
A broad array of factors influence condom use spanning policy, cultural, interpersonal, and individual levels. Condom accessibility through public supply chains, which are largely determined by purchase and distribution policies, has been demonstrated to impact condom uptake [
Across several studies, between one-third and one-half of condom users report poor condom fit [
The premise of fitted condoms is that better fitting condoms may enhance perceptions of pleasure or influence overall preference for men considering condom use. There are two biologically plausible hypotheses for this premise. First, men reporting larger penile size are more likely to describe standard condoms as feeling tight [
MSM are a group meriting particular consideration because they are disproportionately impacted by HIV, accounting for 2 out of every 3 new HIV diagnoses in the United States, with anal sex being the predominant mode of transmission for this group [
The purpose of this research was to better understand whether different types of condoms lead to different experiences of pleasure and clinical failure. This trial compared the performance of fitted, thin, and standard condoms.
This study was a double-blinded, randomized crossover trial of 252 MSM and 252 men who have sex with women (MSW). Participants were enrolled from May 2016 to May 2017. Over a series of in-person study visits, participants received in randomized order a set of 5 fitted condoms, a set of 5 thin condoms, and a set of 5 standard condoms. Participants were followed for 6 to 12 weeks, depending on their use of study condoms in each 2-week period between study visits (
As specified at trial registration [
The study was conducted in accordance with Title 21 US Code of Federal Regulations (CFR) Part 11 and Good Clinical Practice guidelines. The researchers obtained Emory University institutional review board (IRB) approval for the protocol and informed consent forms prior to initiating the study. All participants signed consent forms. All changes to the protocol were submitted to the Emory University IRB for review and approval as appropriate. The principal investigator followed the requirements of the Emory University IRB on periodic reporting of the progress of the study, reporting of serious or unexpected adverse events, and safety monitoring reports. Participants were informed that collected data were intended for publication and that individual details would be de-identified and stored in a secure, password-protected location available only to members of the research team. Additional ethical details can be found in
Primary recruitment for both MSM and MSW was face-to-face venue-based recruitment that took place in a variety of public and private venues in Atlanta where men congregate. Study staff also used secondary recruitment methods that included flyers, paid online advertisements, and recruitment from previous studies. Study sites were the Rollins School of Public Health at Emory University and the Emory Programs, Research, and Innovation in Sexual Minority Health research site. Eligible participants were HIV-negative at their baseline test, aged 18 to 54 years, lived in the Atlanta metro area, and were currently sexually active. We enrolled 252 HIV-negative MSM and 252 HIV-negative MSW. For purposes of study assignment, men were eligible for the MSM arm if they intended to only have sex with other men in the next 12 weeks, and men were eligible for the MSW arm if they intended to only have sex with women in the next 12 weeks. Per FDA guidance [
Eligibility was assessed in three stages: (1) recruitment screening of less sensitive criteria such as age, (2) phone screening of more sensitive criteria such as genital piercing, and (3) in-person (baseline) screening for reassessment of all eligibility criteria in addition to a negative point-of-care HIV test. Prior to the baseline visit, participants determined their fitted condom size after being mailed instructions and a fitting tool consisting of a paper template graduated with nonsequential numbering and lettering.
Study visit flowchart.
Baseline visit structure.
For purposes of this study, a standard condom is defined by dimensions commonly sourced by the United Nations Population Fund: 185 mm (±10 mm) in length, 53 mm (±2 mm) in width, and 70 microns (±10 microns) in thickness (Lai Peng Lim, BS, email communication, June 23, 2015). Thin condoms for this study were of identical width and length to standard but 50 microns (±5 microns) thick. Fitted condoms with a thickness of 70 microns (±10 microns) were produced in a range of sizes. Participants were given two 10-mL packets per condom of commercially available, condom-compatible water-based lubricants in plain foil packets. All condoms and lubricant used in the study were manufactured for the study by Karex Berhad. See
Within each study arm (MSM or MSW), the crossover condition order (the order in which condoms were provided) was determined by permuted block randomization as indicated by the clinical data management system (CDMS). Eligible study participants were randomized to 1 of 6 orders, with the 6 orders balancing the allocation of conditions (
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, who are responsible for analyses and reporting results to the FDA, will be blinded until after the initial analysis of study results has been conducted. To allow for blinded participants to identify preferred condoms (aim 2), we provided condom sets in color-coded bags. We selected colors that could accommodate common forms of color vision deficiency. Further information on study blinding is available in
A visual depiction of the baseline visit structure is provided in
Eligible participants completed a self-administered electronic survey and were trained on using the home coital log and correct use of condoms (
A visual depiction of follow-up visit events is provided in
For event-level measurement, we used a mobile-optimized, Web-based home daily coital log that was 21 CFR Part 11–compliant. We anticipated that use of this system would minimize recall bias due to shorter time period for recall [
Study staff collected key data using eCRFs. For the baseline visit, information collected included eligibility criteria, basic demographic information, and acute HIV and STD symptoms. For follow-up visits, eCRFs included information regarding documentation of condition crossover, number of condoms distributed and returned, adverse events, and study stops.
The baseline survey included questions in the domains of (1) sexual history, (2) condom history, (3) sexual dysfunction, (4) condom slippage and breakage, (5) lubricant use, (6) therapeutic methods, (7) condom fit and feel, (8) condom perceptions, (9) self-efficacy around condom use, (10) HIV and STD history, (11) partner history, and (12) pleasure at last sex. The baseline questionnaire, which annotates the question source for each area of assessment, has been provided in
The coital log assessed the outcome of pleasure (aim 1) and the outcomes of clinical failure (aims 3 and 4). Based on a literature search and consultation with experts, we identified no extant event-level scale to assess aim 1. Therefore, we developed and validated the Event-level Male Sexual Pleasure Scale (EMSexPleasure), described elsewhere [
We developed a procedure in the coital log to minimize error in self-report of clinical failure events. After initial completion of questions, the system autogenerated a message that provided a summary of participant’s self-report data, with an option to confirm it or to correct it. This message was provided for all reports, whether clinical failure was reported or not reported. For example, for a participant reporting that a condom broke but did not slip, the participant was asked, “You told us that this condom broke but did not slip. Is this correct?” Response options were yes, which led to continuation of the coital log, and no, which led to reinitiation of questions regarding condom failure.
To prevent recall bias from unduly influencing data, we established a set of rules regarding coital log completion at study events. At a study event, if a participant reported using study condoms but had not completed coital logs for them, we allowed a maximum of the past two condom uses to be reported. In these reports, participants entered data regarding clinical failure outcomes (aims 3 and 4) but not regarding event-level pleasure (aim 1) due to the higher potential recall bias for pleasure, which was considered an ephemeral phenomenon.
At crossover visits, participants completed a self-administered behavioral survey in the domains of (1) perceived condom fit of the last study condom used, (2) perceived crossover condition, (3) new sexual partners, and (4) condom preference (at applicable visits). If participants reported any condom use that had not been previously recorded with coital logs, they were allowed to enter coital log data for up to their two most recent condom uses.
Preference, the outcome measure for aim 2, was measured at the final study visit. For each of 3 possible combinations of 2 crossover conditions (standard/thin, thin/fitted, standard/fitted), there was a paired comparison asking participants to select their preferred condom between the 2 relevant study conditions. To maintain blinding, preference question response options were the color assigned to each condom type.
For aim 2 at 80% and 90% power, assuming 80% retention, the minimum underlying values of fitted-condom preference π̂2,1 that would be detectable as significantly higher than 0.5 ranged from 0.56 to 0.57. Given these calculations, we sought to have at least 404 participants complete the trial. Based on our previous studies in Atlanta, we anticipated 20% loss to follow-up from the 504 enrolled participants. This sample size provides an estimated >99% power to detect a statistically significant contrast for aim 1 across a wide range of possible event-level pleasure scores.
The planned primary analysis of aims is described in
The primary analysis of aim 2 will be conducted at the participant-level using binary preference responses for comparison of fitted and standard condoms, collected at the final study visit (
A descriptive assessment for aim 3 will consist of calculating the per–anal sex act clinical failure proportion for the 3 condom conditions by dividing the number of total clinical failures by the total number of acts contributed for each condom type by participants in the MSM arm of the study. We will assess whether the proportion of failure for each condom type is below the threshold value that is to be determined by FDA. In order to adjust for study design, failure will also be assessed with a logistic mixed effects model with random effects for person with arm, condom type, crossover period, and an arm*condom type interaction term. For aim 4, we will use the logistic mixed model described in aim 3 to assess the odds of failure for fitted versus standard condoms within the MSM arm. Instances of anal sex among MSW will not be included in primary analyses because anal sex events occur frequently at the lifetime level for MSW but infrequently at monthly and even yearly levels [
Outcome measures used to assess each study aim.
Aim number and description | Outcome measure | |
1 | To compare fitted condoms with standard condoms regarding levels of reported pleasure as determined by rating per condom use event | Pleasure-scale score (response item mean) for fitted condoms and standard condoms following each coital event |
2 | To compare fitted condoms with standard condoms regarding preference as determined by dichotomous preference among the 2 conditions at the study conclusion | Binary preference of fitted versus standard condoms at final study visit |
3 | To assess for fitted, thin, and standard condoms the total clinical failure rate of each type of condom for anal sex among MSMa relative to a cut-point to be determined by the FDAb | Binary occurrence of clinical failure for each type of condom at each coital event |
4 | To compare fitted condoms with standard condoms regarding total clinical failure for anal sex | Binary occurrence of clinical failure for fitted and standard condoms at each coital event |
aMSM: men who have sex with men.
bFDA: US Food and Drug Administration.
Study data collection was predominantly electronic and conducted through the study CDMS. The study used the Dacima Clinical Suite CDMS platform (Dacima Software Inc) compliant with all relevant FDA standards. For all office visits, eCRFs and the coital log were conducted on the CDMS. The study CDMS was a Web-based application, allowing participants to complete electronic coital logs at home with any device with an up-to-date Web browser. Information collected during recruitment and phone screenings was not collected using the CDMS but instead was collected through an electronic survey system, SurveyGizmo (covered by a Health Insurance Portability and Accountability Act business associate agreement) and transferred to a secure Emory database that allowed for potential participants to be contacted regarding the study. None of the data collected during recruitment and phone screenings was used as part of the study dataset. For coital log entries, participants used a secure link to access study forms that required a log-in with username and password protection. Details on methods for data quality assurance and laboratory procedures are in
The study assessed a total of 13,524 individuals for phase 1 eligibility through field-based screening. Of the 2819 initially eligible individuals, 1037 (36.8%) completed phase 2 eligibility assessment by phone; 681 were eligible and 542 attended a baseline visit. Of the 542 who attended the baseline visit, 504 were enrolled in the trial (93%). Baseline demographic and behavioral characteristics of study participants, by study arm and study condom type, are described in
Baseline demographic and behavioral characteristics of study participants.
Characteristics | Participant strata | Condom type used | |||||||||||
MSMa (n=252), n (%) | MSWb (n=252), n (%) | Blue (n=464), n (%) | Black (n=468), n (%) | Yellow (n=469), n (%) | |||||||||
|
|||||||||||||
|
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< 20 | 10 (4) | 46 (18) | 53 (11) | 50 (11) | 50 (11) | ||||||||
20-24 | 54 (21) | 104 (41) | 146 (31) | 149 (32) | 151 (32) | ||||||||
25-29 | 69 (27) | 54 (21) | 110 (24) | 113 (24) | 111 (24) | ||||||||
30-39 | 71 (28) | 37 (15) | 98 (21) | 100 (21) | 100 (21) | ||||||||
40-54 | 48 (19) | 11 (4) | 57 (12) | 56 (12) | 57 (12) | ||||||||
|
|||||||||||||
Hispanic | 31 (12) | 31 (12) | 56 (12) | 57 (12) | 57 (12) | ||||||||
White non-Hispanic | 122 (48) | 119 (47) | 217 (47) | 219 (47) | 220 (47) | ||||||||
African-American non-Hispanic | 79 (31) | 52 (21) | 125 (27) | 124 (27) | 126 (27) | ||||||||
Other non-Hispanic | 20 (8) | 49 (20) | 65 (14) | 67 (14) | 65 (14) | ||||||||
Prefer not to answer, non-Hispanic | 0 (0) | 1 (0) | 1 (0) | 1 (0) | 1 (0) | ||||||||
|
|||||||||||||
Homosexual/gay | 228 (90) | 0 (0) | 204 (44) | 210 (45) | 205 (44) | ||||||||
Bisexual | 21 (8) | 5 (2) | 24 (5) | 25 (5) | 24 (5) | ||||||||
Heterosexual/straight | 1 (0) | 245 (97) | 234 (50) | 231 (49) | 236 (50) | ||||||||
Other | 2 (1) | 2 (1) | 2 (0) | 2 (0) | 4 (1) | ||||||||
|
|||||||||||||
College, postgraduate, or professional school | 160 (63) | 116 (46) | 253 (55) | 254 (54) | 256 (55) | ||||||||
Some college, associate’s degree, or technical school | 71 (28) | 80 (32) | 138 (30) | 141 (30) | 142 (30) | ||||||||
High school, GEDc, or less | 21 (8) | 56 (22) | 73 (16) | 73 (16) | 71 (15) | ||||||||
|
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<$20,000 | 62 (25) | 85 (34) | 136 (29) | 136 (29) | 138 (29) | ||||||||
$20,000-$29,999 | 35 (14) | 24 (10) | 54 (12) | 55 (12) | 56 (12) | ||||||||
$30,000-$39,999 | 27 (11) | 17 (7) | 42 (9) | 43 (9) | 40 (9) | ||||||||
$40,000-$49,999 | 28 (11) | 18 (7) | 42 (9) | 42 (9) | 44 (9) | ||||||||
≥50,000 | 90 (36) | 85 (34) | 159 (34) | 160 (34) | 160 (34) | ||||||||
Don't know | 10 (4) | 23 (9) | 31 (7) | 32 (7) | 31 (7) | ||||||||
|
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Legally married/registered domestic partnership/civil union | 19 (8) | 26 (10) | 41 (9) | 42 (9) | 43 (9) | ||||||||
Divorced/separated | 11 (4) | 8 (3) | 18 (4) | 17 (4) | 18 (4) | ||||||||
Never married | 222 (88) | 218 (87) | 405 (87) | 409 (87) | 408 (87) | ||||||||
|
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Employed | 203 (81) | 111 (44) | 284 (61) | 291 (62) | 285 (61) | ||||||||
Student | 28 (11) | 133 (53) | 152 (33) | 150 (32) | 155 (33) | ||||||||
Unemployed/retired/other | 21 (8) | 8 (3) | 28 (6) | 27 (6) | 29 (6) | ||||||||
|
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Yes | 8 (3) | 7 (3) | 13 (3) | 12 (3) | 12 (3) | ||||||||
No | 244 (97) | 245 (97) | 451 (97) | 456 (97) | 457 (97) | ||||||||
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Circumcised (cut) | 207 (82) | 211 (84) | 385 (83) | 385 (82) | 387 (83) | ||||||||
Uncircumcised (uncut) | 45 (18) | 41 (16) | 79 (17) | 83 (18) | 82 (17) | ||||||||
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|||||||||||||
1 | 129 (51) | 206 (82) | 307 (66) | 311 (66) | 314 (67) | ||||||||
2 | 56 (22) | 35 (14) | 85 (18) | 87 (19) | 86 (18) | ||||||||
3 | 40 (16) | 9 (4) | 45 (10) | 46 (10) | 45 (10) | ||||||||
≥4 | 27 (11) | 2 (1) | 27 (6) | 24 (5) | 24 (5) | ||||||||
|
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No erectile dysfunction | 157 (62) | 186 (74) | 323 (70) | 317 (68) | 323 (69) | ||||||||
Mild erectile dysfunction | 57 (23) | 39 (15) | 84 (18) | 90 (19) | 90 (19) | ||||||||
Moderate to severe erectile dysfunction | 9 (4) | 1 (0) | 8 (2) | 10 (2) | 8 (2) | ||||||||
Missing | 29 (12) | 26 (10) | 49 (11) | 51 (11) | 48 (10) | ||||||||
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Pill such as Viagra, Cialis, or Levitra | 28 (11) | 2 (1) | 29 (6) | 28 (6) | 29 (6) | ||||||||
Testosterone | 5 (2) | 1 (0) | 6 (1) | 6 (1) | 6 (1) | ||||||||
Injection into your penis to get an erection | 1 (0) | 0 (0) | 1 (0) | 1 (0) | 1 (0) | ||||||||
Vacuum or penis pump to get an erection | 3 (1) | 0 (0) | 3 (1) | 2 (0) | 3 (1) | ||||||||
Penile implant | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||||||||
None of the above | 219 (87) | 245 (99) | 426 (93) | 431 (93) | 431 (93) | ||||||||
Missing | 1 (0) | 4 (2) | 4 (1) | 4 (1) | 4 (1) | ||||||||
|
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|
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Yes | 181 (72) | 201 (80) | 358 (77) | 353 (75) | 358 (76) | ||||||||
No | 56 (22) | 40 (16) | 84 (18) | 92 (20) | 90 (19) | ||||||||
Missing | 15 (6) | 11 (4) | 22 (5) | 23 (5) | 21 (4) | ||||||||
|
|||||||||||||
Not very experienced | 11 (4) | 6 (2) | 17 (4) | 17 (4) | 17 (4) | ||||||||
Somewhat experienced | 55 (22) | 59 (23) | 105 (23) | 108 (23) | 105 (22) | ||||||||
Very experienced | 186 (74) | 187 (74) | 342 (74) | 343 (73) | 347 (74) | ||||||||
|
|||||||||||||
Very good | 36 (14) | 53 (21) | 82 (18) | 83 (18) | 82 (17) | ||||||||
Good | 85 (34) | 105 (42) | 179 (39) | 175 (37) | 179 (38) | ||||||||
Moderate | 47 (19) | 34 (13) | 77 (17) | 75 (16) | 77 (16) | ||||||||
Poor | 12 (5) | 9 (4) | 19 (4) | 19 (4) | 19 (4) | ||||||||
Very poor | 1 (0) | 0 (0) | 1 (0) | 1 (0) | 1 (0) | ||||||||
Missing | 71 (28) | 51 (20) | 106 (23) | 115 (25) | 111 (24) | ||||||||
|
|||||||||||||
Very good | 28 (11) | 44 (17) | 66 (14) | 67 (14) | 67 (14) | ||||||||
Good | 73 (29) | 99 (39) | 166 (36) | 165 (35) | 166 (35) | ||||||||
Moderate | 49 (19) | 44 (17) | 86 (19) | 81 (17) | 85 (18) | ||||||||
Poor | 29 (12) | 14 (6) | 38 (8) | 38 (8) | 38 (8) | ||||||||
Very poor | 2 (1) | 0 (0) | 2 (0) | 2 (0) | 2 (0) | ||||||||
Missing | 71 (28) | 51 (20) | 106 (23) | 115 (25) | 111 (24) | ||||||||
|
|||||||||||||
Scored below 16 | 116 (46) | 130 (52) | 226 (49) | 229 (49) | 227 (48) | ||||||||
Scored 16 | 136 (54) | 122 (48) | 238 (51) | 239 (51) | 242 (52) | ||||||||
|
|||||||||||||
Yes | 59 (23) | 94 (37) | 140 (30) | 142 (30) | 140 (30) | ||||||||
No | 164 (65) | 132 (52) | 275 (59) | 275 (59) | 281 (60) | ||||||||
Missing | 29 (12) | 26 (10) | 49 (11) | 51 (11) | 48 (10) | ||||||||
|
|||||||||||||
Yes | 77 (31) | 72 (29) | 138 (30) | 141 (30) | 138 (29) | ||||||||
No | 146 (58) | 154 (61) | 277 (60) | 276 (59) | 283 (60) | ||||||||
Missing | 29 (12) | 26 (10) | 49 (11) | 51 (11) | 48 (10) | ||||||||
|
|||||||||||||
Yes | 81 (32) | 86 (34) | 158 (34) | 154 (33) | 152 (32) | ||||||||
No | 142 (56) | 140 (56) | 257 (55) | 263 (56) | 269 (57) | ||||||||
Missing | 29 (12) | 26 (10) | 49 (11) | 51 (11) | 48 (10) |
aMSM: men who have sex with men.
bMSW: men who have sex with women.
cGED: general education development.
dErectile function scaled using the 5-item International Index of Erectile Function questionnaire [
eCondom self-efficacy scored using a 7-item scale adapted from previous work and with demonstrated evidence of internal reliability [
This protocol describes a blinded, crossover randomized clinical trial designed to compare the performance of standard, thin, and fitted condoms. To our knowledge, this is the first clinical trial of condoms to include preference or pleasure as primary outcomes. Pleasure is an inherently ephemeral experience, and yet is essential to the sexual experience. Qualitative literature is rife with critiques of how condoms are perceived to limit pleasure. For instance, condom use has been described as similar to “eating candy with the wrapper on” in settings as diverse as Brazil [
A key feature of the study design is recruitment of equal numbers of MSM and MSW. Studies assessing condom performance among MSM are merited due to disparate impact of HIV, with over 2 out of every 3 new HIV diagnoses in the United States in 2015 occurring among MSM [
This study incorporated a number of practices to minimize potential bias of primary outcomes. To minimize recall bias, participants were provided with the electronic coital log to complete following sex acts. Automated daily electronic reminders encouraged participants to complete a coital log entry for any sex acts not previously reported. Another advantage of electronic data collection is that it allowed for show/hide and piping features that turned what would have been a confusing paper report form into a short series of simple, answerable questions. Survey logic enabled by electronic data collection also allowed for us to incorporate a methodological innovation to decrease misreporting of condom failure; the survey system autogenerated a message that provided a summary of participant’s self-report data, with an option to confirm it or to correct it. Given that a small proportion of incorrectly reported data (eg, 3%) could substantially influence the likely rare study outcome of condom failure, we view this data validation step as holding substantial potential value.
To minimize response and recall bias, financial incentives were provided for regular participant use of the coital log; the same incentive amount was provided for coital log reports of no sex as for coital log reports of using study condoms. In contrast, some past studies required participants to use all of a set of study condoms prior to receiving incentives at their next study visit [
This study is subject to a number of limitations. There is no gold standard laboratory measurement of clinical condom failure, condom preference, or pleasure. Instead, study outcomes rely on self-report, which multiple reviews have identified as problematic for reporting of outcomes relating to sex [
In conclusion, this study protocol describes a clinical trial of condoms that incorporates novel outcomes of pleasure and preference into the primary aims and uses a number of methods to minimize potential sources of bias. The trial includes outcomes for both MSM and MSW, allowing for enhanced understanding of condom performance among a key population. Trial results may inform FDA label indication for anal sex and provide new information regarding the relative performance of different types of condoms.
World Health Organization registration and extended information.
Text appendices.
Follow-up visit structure.
Baseline visit questionnaire.
clinical data management system
US Code of Federal Regulations
electronic case report form
US Food and Drug Administration
institutional review board
International Organization for Standardization
men who have sex with men
men who have sex with women
sexually transmitted disease
We appreciate and acknowledge the contributions of our study participants. Thanks to our clinical laboratory partner, the Emory Center for AIDS Research Clinical Virology Laboratory, led by Dr Colleen Kraft, and to the manufacturer of all study product, Karex Berhad. This study is funded by Small Business Innovative Research grants from the National Institutes of Health (R43HD078154 and R44HD078154). The study was facilitated by the Center for AIDS Research at Emory University (P30AI050409).
AJS, PSS, MPC, and EMR were the lead investigators and were responsible for study conception and design. ESR was the coordinating researcher and was responsible for overseeing recruitment and data collection. CFK was the study physician. CCM and RHM contributed to the data cleaning and analysis. AJS, EMR, and LA drafted the manuscript. All authors read, edited, and approved the final manuscript.
AJS, EMR, PSS, LA, CFK, CCM, RHM, and ESR have no conflicts of interest to declare. MPC is the owner of TheyFit LLC. On January 26, 2016, TheyFit LLC sold all assets pertaining to the study aims including trademarks, intellectual property, inventory, website, and regulatory approvals to Karex Berhad. MPC has no financial interest in Karex Berhad.