Improving Cervical Cancer Screening Among HIV-Infected Women in India
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|ClinicalTrials.gov Identifier: NCT02247999|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : May 2, 2019
- 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.
- To improve cervical cancer screening methods in HIV-infected women in India.
- 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.
- 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
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|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|
HIV-infected women attending HIV care and treatment clinics in Pune, Chennai, andBelgaum in India.
- Cervical Intraepithelial Neoplasia Grade II or more severe [ Time Frame: At enrollment ]Cervical Intraepithelial Neoplasia Grade II or more severe
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
|National Institute of Epidemiology (NIE)|
|Principal Investigator:||Nicolas Wentzensen, M.D.||National Cancer Institute (NCI)|