Specimen Collection Study for Development and Validation of Laboratory Procedures

NCT ID: NCT01236027

Last Updated: 2020-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2020-03-17

Brief Summary

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.

Conditions

Laboratory Procedure Development and Validation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HIV-negative women

HIV-negative women who agree to have specimens collected for validation of laboratory procedures

no intervention

Intervention Type: OTHER

not applicable-no intervention

Interventions

no intervention

not applicable-no intervention

Intervention Type: OTHER

Eligibility Criteria

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.

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

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Katherine Bunge

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon L Hillier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO10080337

Identifier Type: -

Identifier Source: org_study_id