Status:
COMPLETED
Improving Cervical Cancer Screening Among HIV-Infected Women in India
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
HIV/AIDS
Eligibility:
FEMALE
18+ years
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...
Detailed Description
Background: While HPV DNA testing is a highly sensitive screening method for cervical cancer, it cannot differentiate between the majority of benign infections and few persistent infections linked to...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- Confirmed HIV-1 infection.
- 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.
- If recently given birth, must be at least 12 weeks postpartum.
- Physical and mental ability and willingness of participant to provide written informed consent.
- EXCLUSION CRITERIA:
- Current or prior history of cervical, vaginal, or vulvar cancer.
- Prior treatment for cervical disease; including treatment by cervical cryotherapy, LEEP, cervical conization, total or partial hysterectomy, chemotherapy, or radiation therapy.
- Prior cervical procedure in the past 6 months, including dilatation and curettage (D\&C).
- Serious illness requiring systemic treatment or hospitalization within 21 days prior to study entry.
- 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.
Exclusion
Key Trial Info
Start Date :
November 28 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02247999
Start Date
November 28 2012
End Date
October 8 2020
Last Update
October 9 2020
Active Locations (1)
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1
National Institute of Epidemiology (NIE)
Chennai, India