Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT00121459
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT00121459
Study Brief:
Protocol Section:
NCT00121459