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

Secondary Cervical Cancer Prevention of Vulnerable Women With Human Papillomavirus (HPV) and Human Immunodeficiency Virus (HIV) Co-infection in India

This trial will test whether a six-month ASHA-Health program of group education, ASHA-supported one-on-one sessions, nutrition support, and life-skills training can reduce persistent high-risk HPV in women living with HIV.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 25 Years to 50 Years
• Sex: Female
• Sponsor: University of California, Irvine (Academic / other)
• Locations: 1 site (Bangalore, Karnataka)
• Trial ID: NCT07209917 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women living with HIV aged 25–50 who are on antiretroviral therapy for over 12 months, test positive for oncogenic HPV by RT-PCR, are VIA-negative, and receive care at the participating ART centers in Karnataka.

Not a fit: Women who are pregnant or lactating, older than 50, HPV-negative, VIA-positive with existing lesions, or on ART for less than 12 months are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could lower persistent high-risk HPV rates and reduce the future risk of cervical precancer and cancer among women living with HIV.

How similar studies have performed: Previous community health worker and psychosocial/nutrition programs have improved screening uptake and psychosocial outcomes, but randomized evidence showing a direct reduction in persistent high-risk HPV is limited, making this approach relatively novel for that specific endpoint.

Eligibility criteria

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 this trial is running

Bangalore, Karnataka

• KC General Hospital — Bangalore, Karnataka, India (Recruiting)

Study contacts

• Principal investigator: Adey Nyamathi, ANP, PhD, FAAN — UCI Sue & Bill Gross School of Nursing
• Study coordinator: Veena Satyanarayana

Conditions Cervical Cancer; Human Papillomavirus Infection; Human Immunodeficiency Virus Infection; Cervical Cancer Prevention; HPV-HIV Co-Infection; ASHA-Nutrition