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New study tests HPV vaccine effectiveness and At-Home screening for women with HIV

NCT ID NCT06144229

Knowledge-focused Sponsor: University of California, Los Angeles 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how well the HPV vaccine works in women living with HIV and whether self-collected HPV tests can improve cervical cancer screening. About 650 women will use a self-swab kit at home or in the clinic. Those with positive results will get follow-up exams. The goal is to better protect this group from cervical cancer.

What this could mean

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

Active substance
HPV vaccine (effectiveness study) and self-collection HPV testing kit
What this could lead to
If successful, this could show how well the HPV vaccine works in women with HIV and improve cervical cancer screening methods for this group.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The findings may not apply to all women with HIV.

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 650 people

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

Started

Nov 2024

Expected to finish

Jan 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.

Who is studied

Approximately 810 WLHIV greater than or equal to 21 years of age to less than or equal to 40 years of age who are current participants in PHACS (SMARTT, AMP Up, and AMP Up Lite) or HOPE will be tested for hrHPV using a Food and Drug Administration (FDA)-approved primary hrHPV screening test from self-collected specimens.

Ages

21 to 40 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: * At least 21 years of age and less than or equal to 40 years of age; * WLHIV regardless of mode of transmission or HPV vaccination status; * Current enrollment in the Pediatric HIV/AIDS Cohort Study (PHACS),Surveillance Monitoring for ART Toxicities (SMARTT), Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up), Adolescent Master Protocol for Participants 18 Years of Age and Older - Lite (AMP Up Lite), or Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) studies; * Willing to participate and able to provide informed consent; * Willing to grant access to other PHACS/HOPE data; and * Willing to provide access to medical records. Exclusion Criteria: * Currently known to be pregnant via self-report at hrHPV screening for initial consent; * Special consideration: Women who test positive on urine pregnancy test at the baseline colposcopy visit will be asked to defer their colposcopy until after 6 weeks following the end of the pregnancy. However, pregnancy during follow-up will be allowed, and guidelines for endocervical curettage (ECC) and treatment will be followed.39 * Women known to have active CIN 2 or greater, undergoing active surveillance with colposcopy (per participant report); * Women with known bleeding disorders; * Women unable to consent for themselves; and * Women with a hysterectomy with removal of the cervix will be excluded from the study and, if such a procedure is conducted during the participant's study enrollment, the individual will be censored from analysis at the last visit prior to the hysterectomy and taken off-study.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease human papilloma virus infection

As listed by the trial registrant

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

HIV HPV

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611-2991, United States

  • Baylor college of Medicine

    Houston, Texas, 77030, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Bronx-Lebanon Hospital Center Health Care System

    The Bronx, New York, 10457, United States

  • Children's Hospital New Orleans

    New Orleans, Louisiana, 70112, United States

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • St. Jude Children's research hospital

    Memphis, Tennessee, 38105, United States

  • Univeristy of Miami

    Miami, Florida, 33136, United States

  • University of Colorado

    Denver, Colorado, 13123, United States

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