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

4 maj 2026 uppdaterad av: Timothy Wilkin, University of California, San Diego

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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

750

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Botswana
    • South-East District
      • Gaborone, South-East District, Botswana
        • Botswana Harvard Health Partnership
        • Kontakt:
        • Huvudutredare:
          • Scott L Dryden-Peterson, MD, MSc
        • Underutredare:
          • Rebecca G Luckett, MD, MPH
        • Underutredare:
          • Doreen Ramogola-Masire, MBBS, PhD, MPH

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Primary HPV screen with management based on HPV types and VIA status
All women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. WLWH who test hrHPV negative will exit the study. Women with hrHPV will return for speculum examination, cervical swab collection, VIA, and histology. Women with HPV 16/18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment only if cervical lesions are seen on VIA. Women who are not treated, but subsequently found to have cervical HSIL on histology, will return for cervical treatment. The choice of treatment modality (TA vs. LEEP/LLETZ) will be determined by the extent of cervical lesions seen on VIA. Women with extensive lesions will undergo LEEP/LLETZ treatment. All women who are enrolled (and therefore hrHPV positive) in the early months of the study will be asked to return for a visit 4-6 months later for repeat HPV testing and cervical histology.
Diagnostiskt test: HPV DNA Testing (Abbott Alinity m HPV Assay)
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.
Procedur: Visual Inspection with Acetic Acid
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.
Andra namn:
  • VIA
Procedur: Cervical Histology (Biopsy Procedures)
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.
Procedur: Cervical Treatment (Thermal Ablation or LEEP/LLETZ)
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.
Andra namn:
  • LEEP
  • Thermal Ablation
  • LEEP/LLETZ
  • LLETZ

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility for a Future Clinical Trial
Tidsram: 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.
From enrollment through Month 6 visit
Proportion Receiving Treatment Under Different Management Strategies
Tidsram: 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.
Baseline through Month 6 visit

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
hrHPV Prevalence and Genotype Distribution
Tidsram: Screening
To describe the hrHPV prevalence and HPV genotype distribution by clinical site.
Screening
Alternative CT Value Cutoffs for Management
Tidsram: 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.
Baseline through Month 6 visit
Rate of Invasive Cancer or CIN 3 Managed With No Treatment
Tidsram: 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).
Baseline through Month 6 visit

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Diego

Samarbetspartners

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

Utredare

  • Studiestol: Timothy J Wilkin, MD, MPH, University of California, San Diego

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

4 maj 2026

Först inskickad som uppfyllde QC-kriterierna

4 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 813535
  • U24CA275417 (U.S.S. NIH-anslag/kontrakt)
  • UG1CA275414 (U.S.S. NIH-anslag/kontrakt)
  • UG1CA275416 (U.S.S. NIH-anslag/kontrakt)
  • C2001P-CS3 (Annan identifierare: National Cancer Institute)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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