Status:
NOT_YET_RECRUITING
Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
National Cancer Institute (NCI)
University of California, San Francisco
Conditions:
Cervical Cancer
Human Papillomavirus (HPV) Infection
Eligibility:
FEMALE
25-50 years
Phase:
NA
Brief Summary
Cervical cancer (CC) remains one of the most common malignancies among women in India, with nearly 100,000 women diagnosed annually and over 60,000 preventable deaths annually. With high-risk human pa...
Detailed Description
In this 5-year parallel-group RCT, the investigators will conduct a RCT to assess the efficacy of our six-month ASHA-Health HPV intervention, featuring: 1) eight in-depth group education sessions by n...
Eligibility Criteria
Inclusion
- WLH, 25 - 50 years of age; based on HIV-based guidelines;
- Receiving ART for \> 12 months to ensure medication stabilization, and ensure any impact on the cervical cancer outcomes will not be attributed solely to recent ART initiation, as validated by an ART card given to all ART patients;
- Screened as HPV positive by RT-PCR (Reverse Transcription Polymerase Chain Reaction) for oncogenic genes; and assessed to be VIA negative;
- Have not participated in Phase I Formative Study.
Exclusion
- Pregnant or lactating women due to hormonal and dietary guideline differences;
- Women older than age 50. These women will be immediately referred to a gynecology specialist.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT07209917
Start Date
February 1 2026
End Date
January 1 2030
Last Update
December 26 2025
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