Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom

Eligibility Criteria

• 1. Be between the ages of 18 and 45 years (inclusive);
• 2. Be literate (able to read a newspaper or letter easily);
• 3. 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;
• 4. Be sexually active (defined as having at least one vaginal coital act per week);
• 5. Willing to give informed consent;
• 6. Willing to complete the male condom coital use reports;
• 7. Willing to use the study condoms as directed;
• 8. Agree to use only the study lubricant provided;
• 9. Agree to only use the study condoms sequentially during time of participation
• 10. Willing to adhere to the follow-up schedule and all study procedures;
• 11. Willing to provide research study staff with an address, phone number or other locator information while participating in the study;
• 12. Willing to participate in the study for the duration of 10 condom uses (approximately 2-3 months);
• 13. Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;
• 14. Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, Intrauterine device (IUD), or have had a tubal sterilization) or male partner vasectomised;
• 15. Agree to return any unopened condoms;
• 16. Male partner willing to ejaculate during vaginal intercourse;
• 17. Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse;
• 18. Agree to not bring study condoms in contact with genital or oral piercing jewelry
• 19. EAH: Both partners have valid personal email and operable mobile phones;
• 20. Former participant in Karex02 Study: male partner measures at least 118 mm in girth of erect penis.
• 21. Agree that information provided in Karex02 study may be used and combined with the information in this study
• 1. Female partner is pregnant or desires to become pregnant during the time of the research study;
• 2. Either partner is known to be HIV positive (based on self report \[EAH\] or documented HIV-negative test result within past two months;
• 3. Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
• 4. Male partner has known erectile or ejaculatory dysfunction;
• 5. Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;
• 6. Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;
• 7. Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU);
• 8. Either partner is currently participating in another condom study;
• 9. Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex;
• 10. Either partner is a sex worker.