Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
Sexually Transmitted Diseases
About this trial
This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Synthetic Male Condom, Slippage-Breakage Study
Eligibility Criteria
Inclusion Criteria: Be between the ages of 18 and 45 years (inclusive); Be literate (able to read a newspaper or letter easily); Have been in an exclusive (monogamous) sexual relationship with partner for at least 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study; Be sexually active (defined as having at least one vaginal coital act per week); Willing to give informed consent; Willing to complete the male condom coital use reports; Willing to use the study condoms as directed; Agree to use only the study lubricant provided; Agree to only use the study condoms sequentially during time of participation Willing to adhere to the follow-up schedule and all study procedures; Willing to provide research study staff with an address, phone number or other locator information while participating in the study; Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months); Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects; Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, IUD, or have had a tubal sterilization) or male partner vasectomised; Agree to return any unopened condoms; Male partner willing to ejaculate during vaginal intercourse; Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse; Agree to not bring study condoms in contact with genital or oral piercing jewelry EAH: Both partners have valid personal email and operable mobile phones; Exclusion Criteria: Female partner is pregnant or desires to become pregnant during the time of the research study; Either partner is known to be HIV positive (based on self report [EAH] or documented HIV-negative test result within past two months [MRU]); Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia); Male partner has known erectile or ejaculatory dysfunction; Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance; Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms; Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU); Either partner is currently participating in another condom study; Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex; Either partner is a sex worker.
Sites / Locations
- Essential Access HealthRecruiting
- Essential Access HealthRecruiting
- MRU (MatCH Research Unit)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Synthetic Nitrile Condoms (53mm)
Synthetic Nitrile Condoms (56mm)
Control Latex Condom
53mm width synthetic nitrile condoms
56mm width synthetic nitrile condoms
Commercial natural rubber latex condom