Specimen Collection Study for Development and Validation of Laboratory Procedures

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.