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Improving Cervical Cancer Screening Among HIV-Infected Women in India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247999
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

  • Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical cancer are caused by the human papillomavirus (HPV). HPV is more common in women who have the human immunodeficiency virus (HIV). India has one of the highest rates of women who have both cervical cancer and HIV infection.
  • Cervical cancer can be discovered in early stages by screening for HPV infection. Researchers want to compare new cervical cancer screening tests for HIV-infected women. They also want to know more about how HPV can lead to cervical cancer in HIV-infected women. To do so, they will hold a study to screen HIV-infected women in India.

Objectives:

- To improve cervical cancer screening methods in HIV-infected women in India.

Eligibility:

  • Women at least 18 years of age who have HIV infection.
  • Participants will be recruited from HIV-focused health care clinics in Pune and Chennai, India.

Design:

  • Participants will have a physical exam and medical history. They will provide a urine sample and proof of HIV infection.
  • Participants will have a gynecological exam. This will involve a pelvic exam and Pap smear to collect cells for study. It will also involve a cervical exam to look for precancerous cells. Cervical tissue may be collected.
  • Participants will also provide a blood sample for testing.
  • Participants will return in 2 weeks for the test results. If there are signs of precancerous or cancer cells, participants will be referred to a doctor for treatment.

Condition or disease
Cervical Cancer HIV/AIDS HPV Cervical Intraepithelial Neoplasia Biomarkers

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Improving Cervical Cancer Prevention Among HIV-Infected Women Using Novel HPV Based Biomarker Assays
Study Start Date : November 28, 2012
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort
HIV-infected women attending HIV care and treatment clinics in Pune, Chennai, andBelgaum in India.



Primary Outcome Measures :
  1. Cervical Intraepithelial Neoplasia Grade II or more severe [ Time Frame: At enrollment ]
    Cervical Intraepithelial Neoplasia Grade II or more severe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be selected from HIV-infected women attending HIV care and treatment clinics in Pune, Chennai, and Belgaum in India.
Criteria
  • INCLUSION CRITERIA:

    1. Female greater than or equal to 18 years of age at study entry. This ensures that all participants are at or above legal age in India for giving informed consent.
    2. Confirmed HIV-1 infection.
    3. For women of reproductive potential, a negative urine pregnancy test with a sensitivity of <25mlU/mL prior to study entry. This ensures that only non-pregnant women are included. While pregnancy is not an absolute contraindication for screening, certain invasive clinical procedures are often postponed until after pregnancy.
    4. If recently given birth, must be at least 12 weeks postpartum.
    5. Physical and mental ability and willingness of participant to provide written informed consent.

EXCLUSION CRITERIA:

  1. Current or prior history of cervical, vaginal, or vulvar cancer.
  2. Prior treatment for cervical disease; including treatment by cervical cryotherapy, LEEP, cervical conization, total or partial hysterectomy, chemotherapy, or radiation therapy.
  3. Prior cervical procedure in the past 6 months, including dilatation and curettage (D&C).
  4. Serious illness requiring systemic treatment or hospitalization within 21 days prior to study entry.
  5. Active drug or alcohol use or dependence or any other condition that, in the opinion of the site investigator, would interfere with the participant s ability to adhere to study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247999


Locations
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India
National Institute of Epidemiology (NIE)
Chennai, India
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nicolas Wentzensen, M.D. National Cancer Institute (NCI)

Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02247999     History of Changes
Other Study ID Numbers: 999913037
13-C-N037
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 23, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Cervical Cancer
HIV/AIDS
HPV
Biomarkers
Screening
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type