Please select the eligibility criteria that correspond to the clinical trial below.
Title: Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
Brief Summary: Chlamydial infection is a common, sexually transmitted disease which women can have without knowing. Untreated, it can lead to an infection of the womb and fallopian tubes called pelvic inflammatory disease (PID), which can cause infertility. There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests. We now need to see if screening using modern tests and self-taken swabs works in a high risk, young, multiethnic female population in the United Kingdom (UK).

The study is a randomised trial. It will involve asking women students in college bars to complete confidential questionnaires on sexual health and to provide self-administered vaginal swabs. We have successfully done this in a small pilot study. Participants will be told that the tests are for research purposes only and that if they think they may have been at risk of a sexually transmitted infection they should get checked at a clinic. If the trial shows that chlamydia screening using these new methods prevents PID, extending this community-based intervention nationwide could improve women's reproductive health and wellbeing and might prevent some women from becoming infertile


Options:
A: Inclusion Criteria:

* Age 18-40 years (inclusive)
* Able and willing to provide written informed consent to be screened for, and to enrol in, the study.
* Able and willing to provide adequate locator information for study retention purposes.
* Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening.
* HIV negative on testing performed by study staff within 30 days of enrolment.
* Have a negative pregnancy test which was performed by study staff within 21 days of enrolment
* Agree to use a non-barrier form of contraceptive
* Agree to adhere to study visits and procedures

Exclusion Criteria:

* History of adverse reaction to latex.
* Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):

  * To travel away from the study site for more than 30 consecutive days.
  * To relocate away from the study site.
  * To become pregnant
  * To enrol in any other study of an investigational product or behaviour modification related to HIV prevention.
* Has a creatinine clearance \<50ml/min, as estimated using the method of Cockcroft and Gault(33).
* Has active Hepatitis B infection (since January 2009)
* Has a clinically apparent pelvic examination finding (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.
* Has in the past year participated in any research related to any vaginally applied product/s.
* Has current STI symptoms and/or other reproductive tract infection requiring treatment, as assessed by study staff. Otherwise eligible participants diagnosed during screening with infection(s) requiring treatment may be enrolled provided that treatment has commenced.
* Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
B: Inclusion Criteria:

* Age 18 through 45 years (inclusive) at screening, verified per site SOPs; within this range, sites may restrict the upper age limit per site SOPs, to target women at high risk of HIV infection
* Able and willing to provide written informed consent to be screened for and to take part in the study
* Able and willing to provide adequate locator information, as defined in site SOPs
* HIV-uninfected based on testing performed by study staff at screening and enrollment (per applicable algorithm in Appendix II)
* Per participant report, sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
* Using an effective method of contraception at enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine device (IUD); and sterilization (of participant, as defined in site SOPs)
* At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation -- Note: Tampons may be used for the duration of the trial.

Exclusion Criteria:

* Per participant report at screening:

  * Intends to become pregnant during study participation
  * Plans to relocate away from the study site during study participation
  * Plans to travel away from the study site for more than 8 consecutive weeks during study participation
* Is pregnant

  -- Note: A documented negative pregnancy test performed by study staff is required for inclusion; however a self-reported pregnancy is adequate for exclusion from the study.
* Currently breastfeeding
* Diagnosed with urinary tract infection (UTI)

  -- Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 28 days of obtaining informed consent for screening, the participant may be enrolled.
* Diagnosed with pelvic inflammatory disease, an STI or reproductive tract infection (RTI) requiring treatment per current WHO guidelines

  -- Note: Otherwise eligible participants diagnosed during screening with pelvic inflammatory disease or STI/RTI requiring treatment per WHO guidelines - other than asymptomatic BV and asymptomatic candidiasis - are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 28 days of obtaining informed consent for screening, the participant may be enrolled. Genital warts requiring treatment also must be treated prior to enrollment. Genital warts requiring therapy are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort.
* Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies

  * Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the Investigator of Record (IoR)/designee is considered expected non-menstrual bleeding and is not exclusionary.
  * Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 28 days of providing informed consent for screening, the participant may be enrolled.
* Participant report and/or clinical evidence of any of the following:

  * Known adverse reaction to any of the study products (ever)
  * Known adverse reaction to latex (ever)
  * Chronic vaginal candidiasis
  * Non-therapeutic injection drug use in the 12 months prior to Screening
  * Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to enrollment
  * Last pregnancy outcome 90 days or less prior to enrollment
  * Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) 90 days or less prior to enrollment
  * Recent participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment
  * Participation in the MTN-003, Vaginal and Oral Interventions to Control the Epidemic (VOICE) clinical trial, or any other HIV prevention study using systemic or topical antiretroviral medications, within 12 months of enrollment
  * As determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease, including active tuberculosis
* Has any of the following laboratory abnormalities at Screening Visit:

  * Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
  * Creatinine Grade 2 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
  * Hemoglobin Grade 2 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
  * Platelet count Grade 1 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
  * Pap result Grade 2 or higher according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)

    * Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process.
    * Note: Women with a documented normal result within the 12 months prior to enrollment need not have Pap smear during the screening period. Women with a Grade 1 abnormal Pap smear can be enrolled upon completion of the initial phase of evaluation if no current treatment is indicated (based on local standard of care for management of abnormal cervical cytology). Need for a repeat Pap within 6 months does not preclude enrollment prior to that result becoming available.
* Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
C: Note: Per the 12/15/06 amendment, all study participants will now enter the Phase IIb study.

Inclusion Criteria:

* HIV uninfected
* Have had sexual intercourse at least once in the 3 months prior to study entry
* Able to provide adequate contact information to study officials for purposes of follow-up

Exclusion Criteria:

* History of adverse reaction to latex
* Nonmedical injection drug use in the 12 months prior to study entry
* Vaginal intercourse more than an average of two times per day in the 2 weeks prior to study entry
* Plan to become pregnant in the 30 months after study entry
* Plan to travel away from the study site for more than 3 consecutive months in the 30 months after study entry
* Plan to relocate away from the study site in the 30 months after study entry
* Participation in another clinical trial of a vaginal product
* Pregnant within 42 days of study entry
* Have a sexually transmitted disease or other reproductive tract infection diagnosed by study staff
* Abnormal pelvic exam indicating deep epithelial disruption
* Condition that, in the opinion of the investigator, may interfere with the study
* Liver or kidney function abnormality of Grade 3 or higher
* Blood or blood clotting abnormality of Grade 4 or higher
D: Inclusion Criteria:

* Sexually active

Exclusion Criteria:

* Never been sexually active
* Tested for chlamydia in past 3 months and no new sexual partner since then
* Pregnant

Answer: D