Specimen Collection Study for Development and Validation of Laboratory Procedures (NCT01236027) | Clinical Trial Compass
CompletedNot Applicable
Specimen Collection Study for Development and Validation of Laboratory Procedures
United States245 participantsStarted 2010-11
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Females, age greater than 50 years
✓. Non-pregnant
✓. Post-menopausal defined as no menses or vaginal bleeding for at least 1 year
✓. Agree to have HIV testing or have documentation of a negative HIV test result within the past 6 months.
✓. 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.
✓. Willing and able to provide written informed consent.
✓. Willing to provide contact information for receipt of laboratory results, as applicable.
✓. Females, 18-45 years of age
Exclusion criteria
✕. Use of hormone replacement therapy, including oral, vaginal and transdermal.