Preventing cervical cancer in women with HPV and HIV in Karnataka, India

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, parallel-group randomized controlled trial enrolling 420 women living with HIV from 24 villages in Karnataka who are HPV-positive and VIA-negative. Participants are randomized 1:1 to a six-month ASHA-Health HPV intervention (eight in-depth group sessions led by clinical and nutrition experts, ASHA-supported one-on-one follow-up, community referrals, and selected life-skills training) or an Enhanced Standard of Care (SOC+) control with three group sessions. The primary outcome is persistence of the same high-risk HPV type measured 12–18 months after baseline, and secondary outcomes include HIV viral load, CD4 count, and serum albumin measured at 6, 12, and 18 months. Enrollment occurs in cohorts of 84 women every six months, and participants must be aged 25–50, on ART for more than 12 months, and receiving care at participating ART centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• KC General Hospital
  Bangalore, Karnataka, India Recruiting
• Swathi Mahila Sangha
  Bangalore, Karnataka, India Recruiting
• Victoria Hospital
  Bangalore, Karnataka, India Recruiting
• General Hospital Jayanagar (GHJ)
  Bengaluru, Karnataka, India Not yet recruiting

Study contacts

• Principal investigator: Adey Nyamathi, ANP, PhD, FAAN — UCI Sue & Bill Gross School of Nursing
• Study coordinator: Veena Satyanarayana
• Email: veena.a.s@gmail.com
• Phone: 91-80-26995180/5877

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.