Improving Cervical Cancer Screening Among HIV-Infected Women in India

NCT02247999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2020-10-09

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nicolas Wentzensen, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-28
Primary Completion
2020-10-08
Completion
2020-10-08

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02247999 on ClinicalTrials.gov