Cervical screening and care options for women living with HIV who test positive for high-risk HPV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective cohort study enrolls women living with HIV who are undergoing cervical cancer screening with primary HPV testing. Participants self-collect vaginal samples for extended HPV genotyping and assess viral load proxies, followed by triage with visual inspection with acetic acid and cervical histology as needed. The trial evaluates how various HPV types beyond 16/18 should be managed and whether current pathways can be optimized for WLWH. Interventions include HPV DNA testing with Abbott Alinity m, VIA, and cervical procedures such as biopsy, thermal ablation, or LEEP/LLETZ. The aim is to establish feasibility to inform a future larger trial on optimal management strategies.

Why it matters

Who can join: the full rules

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 participant identifiers affixed to the bottles or packages.
* Aged 25 or older.
* 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.
* Have an intact cervix.

Exclusion Criteria:

* Current symptoms or concern for cervical cancer.
* History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.
* Have undergone cervical hHSIL treatment in the past year.
* Have a history of hysterectomy with removal of the cervix.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of 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.
* 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.

Where it's running

• Kenya Medical Research Institute
  Nairobi, Kenya Recruiting

Study contacts

• Study coordinator: Caique Mello, MPH
• Email: camello@health.ucsd.edu
• Phone: 858-253-6394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.