Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV

CASCADE: A Feasibility Study of HPV Screening and Management Strategies Utilizing Extended Molecular HPV DNA Genotyping and HPV Viral Load in Women Living With HIV

The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and/or 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16/18) are not well defined.

This prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation.

The study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16/18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).

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.