Specimen Collection Study for Development and Validation of Laboratory Procedures

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon Hillier, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01236027
First received: November 4, 2010
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Laboratory Procedure Development and Validation
Other: no intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Collection of Biological Specimens for Development and Validation of Laboratory Procedures to Support Future Clinical Research Studies

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Validation of Laboratory Procedures [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 220
Study Start Date: November 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-negative women
HIV-negative women who agree to have specimens collected for validation of laboratory procedures
Other: no intervention
not applicable-no intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV-negative women

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236027

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Contact: Jamie Haggerty    412-641-5378    jhaggerty@mail.magee.edu   
Principal Investigator: Sharon L Hillier, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Sharon Hillier, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01236027     History of Changes
Other Study ID Numbers: PRO10080337, U19AI082639
Study First Received: November 4, 2010
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 01, 2014