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Identification and Prevention of Cervical Cancer Risk in Women with HIV in India

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062381
Enrollment
420
Registered
2024-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B20-B20- Human immunodeficiency virus [HIV] disease Health Condition 2: R878- Other abnormal findings in specimens from female genital organs

Interventions

Intervention1: ASHA Health: ASHA-Health HPV intervention will focus on improving nutrition
social factors (social support)
behavioral factors (coping skills, problem-solving skills, barriers to treatment adherence (transportation, lack of job skills, ART side effects), and mental health factors (depression, stigma) over 8

Sponsors

National Institutes of Health, National Cancer Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
HR-HPV persistence or 2 positive tests for the same HR-HPV type, separated by 12 to 18 months.Timepoint: 12, 18 months

Secondary

MeasureTime frame
1 HIV outcomes HIV viral load and CD4 count 2 Nutritional indices serum albumin, Vitamin A and Vitamin D for immune support and Iron 3 Mental health depression, HIV internalized stigma, and HPV and HIV stigma fears and 4 Engagement in care HPV and HIV appointment keeping and ART adherenceTimepoint: 6, 12, and 18 months.

Countries

India

Contacts

Public ContactVeena A Satyanarayana

National Institute of Mental Health and Neuro Sciences

veenas@nimhans.ac.in08026995877

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026