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At-Home HPV tests could save lives of women with HIV

NCT ID NCT07624123

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 4 times

Summary

This study looks at whether giving women living with HIV the option to collect their own HPV test samples at home or in their community, with help from health workers, increases how many get screened for cervical cancer. About 17,700 women will take part across multiple clinics. The goal is to find better ways to reach women who might not come to a clinic for screening.

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 17,734 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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 49 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.

Clinic Inclusion Criteria * Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH. * These clinics should also have the ability to collect their own data. * Such clinics could be supported by national programs and bilateral donor-funded initiatives Inclusion Criteria for Medical Record Abstraction * Are living with Human Immunodeficiency Virus (HIV) * Are 25-49 years of age, or as recommended by the Zimbabwe National Screening Guidelines * Live in the catchment areas of or attend a study-eligible clinic * Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because: * They have never undergone cervical cancer screening before, or * They have never undergone HPV-based testing before and are now due for Visual Inspection with Acetic Acid and Cervicography (VIAC), per national guidelines, or * They have previously undergone HPV-based testing, and are now due for follow-up HPV-based testing per national guidelines, and /or * They underwent ablative or excisional treatment for presumed or confirmed cervical dysplasia \>1 year ago and have not had any follow-up cervical cancer screening since treatment. Exclusion Criteria for Medical Record Abstraction * Have had their cervix removed * Are pregnant or \<6 weeks post-delivery * Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral * Have previously been treated for invasive cervical cancer

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Cervix cancer HIV infections 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

    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

  • University of Zimbabwe Clinical Trials Research Centre

    Harare, 263-772287143, Zimbabwe

More trials for these conditions

Other studies related to the condition(s) this trial covers.