Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix
Brief Summary: The purpose of this trial is to determine whether using the diaphragm and a lubricant get can reduce women's risk of acquiring an HIV infection.


Options:
A: Inclusion Criteria:

* Each partner agrees that the relationship has lasted at least 6 months before study entry
* Each partner intends to remain together for at least 12 months after study entry (e.g., state independently that he/she is confident or very confident that they will remain together)
* At least one partner of the couple reports having unprotected intercourse at least once in the 90 days before study entry
* Neither partner has plans to relocate beyond a reasonable distance from the study site
* At least one partner is African American
* At least one partner agrees that he/she is not planning pregnancy within the next 18 months after study entry
* Each partner is aware of his/her partner's HIV serostatus
* Only one partner is HIV seropositive and has known his or her status for at least 3 months before study entry

Exclusion Criteria:

* One or both partners do not have an address where they can receive mail
* One or both partners have significant psychiatric, physical, or neurological impairment that would limit their effective participation as confirmed on a Mini Mental State Examination and/or Quick Test
* History of severe physical or sexual abuse in the 1 year before study entry in the current relationship (e.g., significant enough to require medical, psychological, and/or legal intervention)
* One or both partners are unwilling or unable to commit to participate in the study through to completion
* Both partners have previously participated in an HIV sexual risk-reduction intervention for couples in the 12 months before study entry
* One or both partners are not fluent in English as determined by the informed consent process
B: Inclusion Criteria:

* be biologically female
* be at least 18 years old
* report having exchanged sex for money, goods or drugs within the last month
* report having injected drugs within the last month
* report having unprotected vaginal or anal sex at least once in last 30 days
* report sharing needles/syringes or other injection paraphernalia (i.e., cottons, cookers, water) at least once in the last month
* live in Tijuana, Ciudad Juarez or its suburbs, as determined through municipal boundaries in each city
* test HIV-negative at baseline
* agree to receive antibiotic treatment for chlamydia, gonorrhea, syphilis trichomonas vaginalis or bacterial vaginosis if they test positive at baseline.

Exclusion Criteria:

If women report:

* consistent use of condoms for vaginal and anal sex with all male partners during the previous month
* not being able to provide verification of injection drug use (i.e. track marks)
* not sharing needles/syringes or paraphernalia at least once in the last month
* being under 18 years of age
* being male or transgender
* being incapable of giving informed consent
* planning to permanently move outside of the municipal boundaries of Tijuana or Ciudad Juarez within the next year.
C: 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
D: Inclusion Criteria:

* Female
* African American
* Ages 15-21
* Receiving care at participating clinic
* Vaginal sex in the past 60 days
* Ability to give written informed consent

Exclusion Criteria:

* Married
* Pregnant
* In a detention center

Answer: C