Identification and Prevention of Cervical Cancer Risk in Women with HIV in India
Phase 2
- Conditions
- Health Condition 1: B20-B20- Human immunodeficiency virus [HIV] diseaseHealth Condition 2: R878- Other abnormal findings in specimens from female genital organs
- Registration Number
- CTRI/2024/02/062381
- Lead Sponsor
- ational Institutes of Health, National Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 WLH, 25 to 50 years of age per HIV-based guidelines 2 receiving ART for over two months to ensure medication stabilization, validated by an ART card given to all ART patients 3 screened as HPV positive with self sample vaginal collection 4 assessed to have oncogenic HPV and 5 assessed to be VIA negative for cervical lesions, performed by our trained Auxiliary Nurse Midwife (ANM)
Exclusion Criteria
1 pregnant or lactating women due to hormonal and dietary guideline differences 2 women below 25 years and 3 women determined to be VIA positive as they will be immediately referred to our Gynecology specialist.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HR-HPV persistence or 2 positive tests for the same HR-HPV type, separated by 12 to 18 months.Timepoint: 12, 18 months
- Secondary Outcome Measures
Name Time Method 1 HIV outcomes HIV <br/ ><br>viral load and CD4 count 2 Nutritional indices serum albumin, Vitamin A and <br/ ><br>Vitamin D for immune support and Iron 3 Mental health depression, HIV <br/ ><br>internalized stigma, and HPV and HIV stigma fears and 4 Engagement in care <br/ ><br>HPV and HIV appointment keeping and ART adherenceTimepoint: 6, 12, and 18 months.