Laboratory Procedure Development and Validation
Conditions
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.
Interventions
OTHERno intervention
not applicable-no intervention
Sponsors
University of Pittsburgh
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of Laboratory Procedures | up to 5 years | The primary aim of this study is to collect an adequate number of biological samples, as needed by investigators, to support development and validation of laboratory procedures necessary for upcoming topical microbicide and infectious disease research clinical trials. |
Countries
United States
Outcome results
None listed