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New study aims to keep women with HIV on track for cervical cancer treatment

NCT ID NCT06182241

Knowledge-focused Sponsor: Boston University Charles River Campus 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 4 times

Summary

This study in South Africa works with women who have HIV and abnormal Pap results to find out why some don't follow up for cervical cancer care. Researchers will interview patients and providers, then create a short counseling and navigation program. They will test if the program is practical and acceptable in a small pilot study with 60 women.

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 (counseling and navigation)
What this could lead to
If successful, this could lead to a practical program that helps women with HIV complete cervical cancer treatment, improving survival rates.
What could go wrong
This is a small, early-stage pilot study (80 participants) testing feasibility, not effectiveness. The intervention may not work in larger, diverse populations.

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 80 people

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

Started

Nov 2025

Expected to finish

Sep 2026

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

18 years and older

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.

Aim 1 criteria: Inclusion Criteria: * Having a cervix * Aged 18+ * Living with HIV * Recent high-risk abnormal Pap results within the last month (if needed, we may increase the range by up to 6 months to ensure that we meet our targets). Exclusion Criteria: * Younger than 18 years old * HIV-negative * No cervix/history of hysterectomy * Recent normal or low-risk abnormal Pap results * Unable to provide informed consent or assent in English or isiZulu and/or have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic. Aim 3 criteria: Inclusion Criteria: * Having a cervix * Aged 18+ * Living with HIV * Recent Pap smear test (within the past two months). Exclusion Criteria: * Younger than 18 years old * HIV-negative * No cervix/history of hysterectomy * Unable to provide informed consent in English or isiZulu and/or have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.

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Conditions

The condition(s) this trial relates to.

AIDS cervical cancer HIV infectious disease Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical cancer HIV

Contacts and locations

Locations

  • Boston University

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand

    Durban, KwaZulu-Natal, 4000, South Africa

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