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New program aims to cut cervical cancer risk in vulnerable women

NCT ID NCT07209917

Prevention Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests a program called SAKHI HPV for women in India who have both HPV and HIV. The program provides support from community health workers, group sessions, and nutrition education to help women stay healthy and reduce their risk of cervical cancer. Researchers will compare this program to standard care in 348 women to see if it lowers persistent HPV infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (SAKHI HPV program with ASHA support, group sessions, and nutrition education)
What this could lead to
If successful, this program could reduce persistent HPV infections and lower cervical cancer risk in women with HIV, offering a scalable prevention model.
What could go wrong
This is a behavioral intervention, not a drug, so effects may be modest. The trial is relatively small (348 participants) and results may not apply to other regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 348 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease human papilloma virus infection Infections Uterine Cervical Neoplasms cervical cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer Human immunodeficiency virus (HIV) infection Human papillomavirus (HPV) infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • General Hospital Jayanagar (GHJ)

    NOT_YET_RECRUITING

    Bengaluru, Karnataka, India

  • KC General Hospital

    RECRUITING

    Bangalore, Karnataka, India

  • Swathi Mahila Sangha

    RECRUITING

    Bangalore, Karnataka, India

  • Victoria Hospital

    RECRUITING

    Bangalore, Karnataka, India

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