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Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

RecruitingNAAges 25 Years - 50 YearsFemaleUniversity of California, Irvine
NCT07209917 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 papillomavirus (HR-HPV) as the causative agent for CC, one risk factor that places women at high risk for CC is human immunodeficiency virus (HIV), as impaired immune response against Human papillomavirus (HPV) may result in persistent HR-HPV infection, a critical risk factor for progression of HPV-related cervical oncogenesis. Progression of precancerous lesions among women living with HIV (WLH) is also associated with: 1) lack of HPV screening; 2) high levels of depressive symptoms and stigma; and 3) malnutrition, which negatively impacts the activation and proliferation of immune cells. Yet programs that offer WLH with comprehensive services focused on HPV screening and psychological and nu

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. WLH, 25 - 50 years of age; based on HIV-based guidelines; 2. 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; 3. Screened as HPV positive by RT-PCR (Reverse Transcription Polymerase Chain Reaction) for oncogenic genes; and assessed to be VIA negative; 4. Have not participated in Phase I Formative Study. Exclusion Criteria: 1. Pregnant or lactating women due to hormonal and dietary guideline differences; 2. Women older than age 50 These women will be immediately referred to a gynecology specialist.
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What it tests

  • SAKHI HPV Intervention
  • Enhanced Standard of Care (SOC+)
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Where

4 sites
KC General Hospital
Bangalore, India
Swathi Mahila Sangha
Bangalore, India
Victoria Hospital
Bangalore, India
General Hospital Jayanagar (GHJ)
Bengaluru, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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