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HPV DNA test could slash cervical cancer deaths in High-Risk populations

NCT ID NCT02956031

Diagnosis Sponsor: University of Pretoria Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study evaluates whether an HPV DNA test can more accurately detect pre-cancerous cervical changes than standard Pap smears in 1,500 women in South Africa, including those with and without HIV. Participants undergo HPV testing, followed by colposcopy and biopsy if needed. The goal is to see if this approach improves early detection and could be used for national screening programs.

What this could mean

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

Active substance
HPV DNA test
What this could lead to
If successful, this screening method could reduce cervical cancer deaths by catching pre-cancer earlier, especially in regions with high HIV rates.
What could go wrong
This is a diagnostic study, not a treatment trial. The screening test may still miss some cases or lead to unnecessary follow-up procedures.

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.

Participants

About 1,500 people

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

Started

Dec 2016

Expected to finish

Dec 2038

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.

Who is studied

This is a multicentric study carried out in South Africa. Women with unknown HIV status will be recruited from the general population, and HIV positive women from adult antiretroviral treatment (ART) clinics.

Ages

25 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Informed consent accepted and signed * Health seeking behaviour or request for a cervical cancer screening test * Willing and able to receive test result by automated text message or clinic visit Exclusion Criteria: * Current pregnancy * Hysterectomy * Current or previous treatment for gynaecological cancer * Hesitant or unable to undergo screening and treatment if indicated

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical intraepithelial neoplasia grade 2/3 cervical squamous intraepithelial neoplasia cervix disorder squamous cell intraepithelial neoplasia Squamous Intraepithelial Lesions Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical cancer CIN2 High grade sil

How to take part

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

  1. The places running it

    1 site. 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

  • Steve Biko Academic Hospital

    RECRUITING

    Pretoria, Gauteng, South Africa

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