Improving Cervical Cancer Screening Among HIV-Infected Women in India

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.

Sex

Female

Minimum age

18 Years

* 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.

• BACKGROUNDSahasrabuddhe VV, Luhn P, Wentzensen N. Human papillomavirus and cervical cancer: biomarkers for improved prevention efforts. Future Microbiol. 2011 Sep;6(9):1083-98. doi: 10.2217/fmb.11.87. PMID 21958146
• BACKGROUNDWentzensen N, Fetterman B, Castle PE, Schiffman M, Wood SN, Stiemerling E, Tokugawa D, Bodelon C, Poitras N, Lorey T, Kinney W. p16/Ki-67 Dual Stain Cytology for Detection of Cervical Precancer in HPV-Positive Women. J Natl Cancer Inst. 2015 Sep 15;107(12):djv257. doi: 10.1093/jnci/djv257. Print 2015 Dec. PMID 26376685
• BACKGROUNDMane A, Nirmalkar A, Risbud AR, Vermund SH, Mehendale SM, Sahasrabuddhe VV. HPV genotype distribution in cervical intraepithelial neoplasia among HIV-infected women in Pune, India. PLoS One. 2012;7(6):e38731. doi: 10.1371/journal.pone.0038731. Epub 2012 Jun 19. PMID 22723879