Effectiveness of the Diaphragm for HIV Prevention

Inclusion Criteria:

• Age 18 to 49 years old
• Sexually active (coital frequency at least four times per month on average)
• HIV negative based on testing within two weeks prior to enrollment
• Chlamydia trachomatis and Neisseria gonorrhoeae negative based on testing within 30 days prior to enrollment or if positive, completes treatment before enrollment
• Have a healthy cervix, as assessed by naked-eye speculum exam at enrollment
• Planning to live in the study area for the next 24 months
• Willing to be randomly assigned either to use or not use a latex diaphragm with lubricant gel during participation in the study, and to follow the protocol, including being tested for HIV and STIs
• Willing and able to give informed consent

Exclusion Criteria:

• Known sensitivity or allergy to latex
• History of TSS (as suggested by current labeling for diaphragm use)
• Currently pregnant, or desiring to become pregnant in the next two years
• No cervix (total hysterectomy)
• Refuses treatment for diagnosed or suspected current STI and/or reproductive tract infection requiring treatment at enrollment
• Within six weeks of any pelvic surgery or last pregnancy outcome at the time of screening and enrollment
• Presence of clinically apparent lesion(s) with epithelial disruption at enrollment (may enroll after lesion(s) has healed, if otherwise eligible)
• Injected illicit drugs in the 12 months prior to screening and enrollment
• Blood transfusion or received blood products in 3 months prior to screening and enrollment
• Unable or unwilling to insert the diaphragm correctly
• Participation in any other clinical trial (including those of a vaginal product or barrier contraceptive). Verification by comparing participant lists to other concurrently running research studies may be conducted if necessary.
• Unable to speak English, Zulu, Shona, or Sotho
• Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as a major psychiatric disorder