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NCT Number: NCT07576842

Testing the Feasibility of Different HPV Screening and Care Strategies for 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).

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Key information

Conditions

Human Papillomavirus (HPV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Cervical Cancer Cervical Intraepithelial Neoplasia (CIN) Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections HPV Associated Cancers Human Immunodeficiency Virus (HIV) Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site Precancerous Conditions RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Botswana Harvard Health Partnership

Gaborone, South-East District, Botswana

Location contact

Doreen Ramogola-Masire, MBBS, PhD, MPH

SUB_INVESTIGATOR

Rebecca G Luckett, MD, MPH

SUB_INVESTIGATOR

Scott L Dryden-Peterson, MD, MSc

CONTACT

[email protected]

617-732-8881

Scott L Dryden-Peterson, MD, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 infection, as documented by:
  • 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
  • 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
  • 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.

Treatment and study plan

HPV DNA Testing (Abbott Alinity m HPV Assay)

Diagnostic Test

Women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. The Alinity m HR HPV assay is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of high-risk HPV DNA. The assay detects 14 hrHPV genotypes by targeting the conserved L1 region of HPV DNA and provides individual or group-level genotyping results, including separate readouts for HPV 16, HPV 18, and HPV 45, and grouped detection of other high-risk types. The assay also provides a proxy for HPV viral load as measured by the cycle threshold (CT) value for the type- or group-specific readout.

Visual Inspection with Acetic Acid

Procedure

Participants with hrHPV detected will undergo visual inspection with acetic acid (VIA) during a speculum examination. Standard acetic acid (3-5%) is applied to the cervix, and the provider will assess for the presence of cervical lesions, determine suitability for ablative treatment, and characterize the transformation zone (TZ1, TZ2, or TZ3). VIA findings will be used to guide participant management and treatment decisions.

Other names: VIA

Cervical Histology (Biopsy Procedures)

Procedure

Cervical histology specimens will be obtained from participants with hrHPV detected. Biopsies may include lesion-directed cervical punch biopsies, endo- and ectocervical soft-brush biopsies, or endocervical curettage (ECC). At least two biopsies will be obtained even if no lesions are seen. For participants undergoing LEEP/LLETZ, histology will be obtained through the excisional procedure. Cervical histology will be processed locally and interpreted according to the lower anogenital squamous terminology (LAST), including p16 testing where available to confirm morphologic-appearing CIN 2.

Cervical Treatment (Thermal Ablation or LEEP/LLETZ)

Procedure

Women with HPV 16 and/or 18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment if cervical lesions are seen on VIA. Women who are not treated but are subsequently found to have cervical high-grade squamous intraepithelial lesions (hHSIL) on histology will return for cervical treatment. Treatment modality will be determined based on the extent of cervical lesions, with thermal ablation (TA) used for lesions appropriate for ablative therapy and LEEP/LLETZ used for more extensive lesions.

Other names: Thermal Ablation, LEEP/LLETZ, LEEP, LLETZ

Primary outcomes

  1. Feasibility for a Future Clinical Trial

    Time frame: From enrollment through Month 6 visit

    To describe the feasibility for a future clinical trial testing various management strategies for women with non-16/18 hrHPV by examining the proportion of potentially eligible women agreeing to study participation, the timeliness and proportion of women receiving the HPV results, the proportion returning for baseline evaluation, and the proportion retained for the Month 6 visit.

  2. Proportion Receiving Treatment Under Different Management Strategies

    Time frame: Baseline through Month 6 visit

    To estimate the proportion of women living with HIV (WLWH) with hrHPV infection and cervical high-grade squamous intraepithelial lesions (hHSIL) who receive treatment under three different management strategies: visual inspection with acetic acid (VIA) triage, genotype restriction alone, and genotype restriction plus HPV viral load.

Secondary outcomes

  1. hrHPV Prevalence and Genotype Distribution

    Time frame: Screening

    To describe the hrHPV prevalence and HPV genotype distribution by clinical site.

  2. Alternative CT Value Cutoffs for Management

    Time frame: Baseline through Month 6 visit

    To explore alternative Abbott Alinity m CT value cutoffs for non-16/18 hrHPV to determine which women are managed with cervical treatment.

  3. Rate of Invasive Cancer or CIN 3 Managed With No Treatment

    Time frame: Baseline through Month 6 visit

    To estimate the rate of invasive cancer or cervical intraepithelial neoplasia (CIN) 3 managed with no treatment for the various management strategies (i.e., VIA triage, genotype restriction, and genotype restriction with incorporation of HPV viral load).

Study contacts

Contact information is provided by the study sponsor or research team.

Caique Mello, MPH

CONTACT

[email protected]

858-253-6394

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Botswana Harvard Health Partnership
  • Brigham and Women's Hospital
  • Frontier Science & Technology Research Foundation, Inc.
  • H. Lee Moffitt Cancer Center and Research Institute
  • National Cancer Institute (NCI)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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