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

Inclusion 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 relationshipwith 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 otherlocator 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 excludeco-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 penisafter 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 girthof erect penis.

21. Agree that information provided in Karex02 study may be used and combined with theinformation in this study

Exclusion Criteria:

1. Female partner is pregnant or desires to become pregnant during the time of theresearch study;

2. Either partner is known to be HIV positive (based on self report [EAH] or documentedHIV-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 asdetermined 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, Universityof the Witwatersrand, or Karex;

10. Either partner is a sex worker.