New study aims to improve cervical cancer detection in HIV-Positive women
NCT ID NCT06002126
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares different HPV tests to find the best way to screen for cervical cancer in women living with HIV in Latin America. Over 1,000 participants will provide cervical, vaginal, and urine samples, plus undergo colposcopy and biopsies. The goal is to identify which test most accurately detects precancerous lesions, enabling same-day diagnosis and treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Xpert HPV test
- What this could lead to
- If successful, this could identify the most accurate and practical HPV testing method to prevent cervical cancer in women with HIV.
- What could go wrong
- This is an observational diagnostic study, not a treatment trial. Results may not apply to all populations or settings.
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
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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
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1,001 people
The number who actually took part.
- Started
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Aug 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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25 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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 * HIV-1 infection, as documented by 1) any FDA approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA, test kit, and confirmed by Western blot or other approved test), OR 2) a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, OR 3) documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with two participant identifiers affixed to the bottles or packages. * Female. * Aged 25 to 65. * Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant. Exclusion Criteria * History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer. * Have undergone cervical cancer screening in the last 6 months. * Have undergone cervical HSIL treatment in the past year. * Have a history of hysterectomy with removal of the cervix. * Have never had sexual intercourse (oral or genital or anal). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of Acquired Immunodeficiency Syndrome-AIDS and/or genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study due to the lack of safety data of performing colposcopy during pregnancy. * Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators.
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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.
Contacts and locations
Locations
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National Institute of Public Health, Mexico
Cuernavaca, Morelos, 62209, Mexico
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University of São Paulo
São Paulo, São Paulo, 05403-911, Brazil
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