N/A
N=504
Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02753842 ↗Enrolled (actual)
504
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Sexual Pleasure Scale Score for Fitted Versus Standard Condoms — 71.52; 70.13 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Global Protection Corp.
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sexual Pleasure Scale Score for Fitted Versus Standard Condoms |
71.52; 70.13 | <0.05 sig |
| PRIMARY Percent of Participants Preferring Fitted Condoms to Standard Condoms |
53.0 | >0.05 |
| PRIMARY Clinical Condom Failure for Anal Sex |
5; 6; 5 | — |
| PRIMARY Clinical Condom Failure of Fitted Condoms Compared to Standard Condoms for Anal Sex |
5; 5 | >0.05 |
| SECONDARY Sexual Pleasure Scale Score for Thin Versus Standard Condoms |
71.19; 70.13 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02753842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.