Specimen Collection Study for Development and Validation of Laboratory Procedures
Specimen Collection Study for Development and Validation of Laboratory Procedures
Biologic samples are necessary for development and validation of laboratory procedures (e.g.
 novel biological and analytical assays, explant tissue models, validation of specimen
 collection and transport) to support future infectious disease clinical studies. In this
 research study, the investigators will collect blood samples, vaginal swabs, cervical swabs,
 mucus/vaginal discharge, cervicovaginal lavages, vaginal and cervical biopsies, as necessary,
 to use in the development of laboratory processes. The investigators will obtain the
 sample(s) from healthy HIV negative women. Samples will be collected and sent to Magee-Womens
 Research Institute as laboratory specimens are needed.
Inclusion Criteria:

 Control Group (post-menopausal) Inclusion:

 1. Females, age greater than 50 years

 2. Non-pregnant

 3. Post-menopausal defined as no menses or vaginal bleeding for at least 1 year

 4. Agree to have HIV testing or have documentation of a negative HIV test result within
 the past 6 months.

 5. Free from participant report and clinician observed abnormal discharge or other
 vaginal symptoms (with the exception of vaginal dryness) on the day of genital sample
 collection.

 6. Willing and able to provide written informed consent.

 7. Willing to provide contact information for receipt of laboratory results, as
 applicable.

 Reproductive-aged Group Inclusion Criteria:

 1. Females, 18-45 years of age

 2. Non-pregnant

 3. Agree to have HIV testing or have documentation of a negative HIV test result within
 the past 6 months.

 4. Free from participant reports and clinician observed abnormal vaginal discharge or
 other current vaginal symptoms on the day of genital sample collection.

 5. Willing and able to provide written informed consent.

 6. Willing to provide contact information for receipt of laboratory results, as
 applicable.

 7. Participant meets requirements of specific laboratory study needs (e.g. birth control
 method and length of use)

 Exclusion Criteria:

 Control Group (post-menopausal) Exclusion Criteria:

 1. Use of hormone replacement therapy, including oral, vaginal and transdermal.

 2. Hysterectomy.

 3. An active urogenital infection within the past 14 days, including:

 1. Vaginal infections (symptomatic candidiasis, trichomonas vaginalis, and bacterial
 vaginosis).

 2. Cervical infections (Gonorrhea (GC), Chlamydia (CT) or mucopurulent cervicitis
 (MPC)).

 3. Syphilis

 4. HSV/Genital Warts

 5. Urinary Tract Infection

 6. Recent exposure to a partner with GC, CT, trichomonas, syphilis, non-gonococcal
 urethritis, or HIV.

 4. Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample
 collection.

 5. Participation in a microbicide or other vaginal product study within one month of
 genital sample collection.

 6. Use of a spermicide or spermicidally lubricated condom within one week prior to
 genital sample collection.

 7. Use of an internal vaginal device or product with the exception of tampons within one
 week of genital sample collection.

 8. Any other condition in the opinion of the site investigator would preclude provision
 of informed consent, make participation in the study unsafe, complicate interpretation
 of study outcome data or otherwise interfere with achieving study objectives.

 Reproductive-aged Group Exclusion Criteria:

 1. Menopausal (including natural menopause defined as lack of menses for 12 consecutive
 months, in the absence of pregnancy, and surgical menopause defined as a woman who has
 had both ovaries removed).

 2. Currently pregnant (or has been pregnant within the past 90 days) or breastfeeding

 3. Hysterectomy.

 4. Use of a diaphragm or NuvaRing for contraception or use of spermicide for primary
 contraception.

 5. An active urogenital infection within the past 14 days, including:

 1. Vaginal infections (symptomatic candidiasis, Trichomonas vaginalis and bacterial
 vaginosis).

 2. Cervical infections (Gonorrhea (GC), Chlamydia (CT) or Mucopurulent cervicitis
 (MPC).

 3. Syphilis

 4. HSV/Genital Warts

 5. Urinary Tract Infection

 6. Recent exposure to a partner with GC, CT, Trichomonas, syphilis, Non-gonococcal
 urethritis or HIV.

 6. Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample
 collection.

 7. Participation in a microbicide and/or contraceptive study within one month of genital
 sample collection.

 8. Use of a spermicide or spermicidally lubricated condom within one week prior to
 genital sample collection.

 9. Use of an internal vaginal device or product with the exception of tampons within one
 week of genital sample collection.

 10. Any other condition in the opinion of the site investigator 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.