Specimen Collection Study for Development and Validation of Laboratory Procedures

November 10, 2020 updated by: Katherine Bunge, University of Pittsburgh

Collection of Biological Specimens for Development and Validation of Laboratory Procedures to Support Future Clinical Research Studies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

HIV-negative women

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HIV-negative women
HIV-negative women who agree to have specimens collected for validation of laboratory procedures
Other: no intervention
not applicable-no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validation of Laboratory Procedures
Time Frame: 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.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO10080337

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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