Bringing cervical cancer screening to women with HIV: can Home-Delivered HPV tests make a difference?

NCT ID NCT07428330

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to offer cervical cancer screening to women living with HIV: standard clinic-based screening versus adding community outreach where health workers provide HPV self-collection kits at home or in community settings. About 7,600 women across multiple clinics will take part. The goal is to see if the community approach increases how many women get screened.

What this could mean

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

Active substance
HPV self-collection kit
What this could lead to
If successful, this could show that community-based HPV self-collection is a practical way to increase cervical cancer screening rates among women living with HIV.
What could go wrong
This is an implementation study, not a test of a new treatment. It may not prove that screening reduces cancer rates, and results may vary by location.

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 7,597 people

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

Started

Feb 2026

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 Uganda's Ministry of Health Cervical Cancer Prevention and Control 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 Acetic Acid (VIA), 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 \<3 months 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 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Makerere University Walter Reed Program

    RECRUITING

    Kampala, 16524, Uganda

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