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

4 de maio de 2026 atualizado por: 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).

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

750

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Botsuana
    • South-East District
      • Gaborone, South-East District, Botsuana
        • Botswana Harvard Health Partnership
        • Contato:
        • Investigador principal:
          • Scott L Dryden-Peterson, MD, MSc
        • Subinvestigador:
          • Rebecca G Luckett, MD, MPH
        • Subinvestigador:
          • Doreen Ramogola-Masire, MBBS, PhD, MPH

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Teste de diagnostico: 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.
Procedimento: 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.
Outros nomes:
  • ATRAVÉS DA
Procedimento: 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.
Procedimento: 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.
Outros nomes:
  • LEEP
  • Thermal Ablation
  • LEEP/LLETZ
  • LLETZ

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Feasibility for a Future Clinical Trial
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
hrHPV Prevalence and Genotype Distribution
Prazo: Screening
To describe the hrHPV prevalence and HPV genotype distribution by clinical site.
Screening
Alternative CT Value Cutoffs for Management
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of California, San Diego

Colaboradores

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

Investigadores

  • Cadeira de estudo: Timothy J Wilkin, MD, MPH, University of California, San Diego

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de maio de 2026

Primeira postagem (Real)

8 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 813535
  • U24CA275417 (Concessão/Contrato do NIH dos EUA)
  • UG1CA275414 (Concessão/Contrato do NIH dos EUA)
  • UG1CA275416 (Concessão/Contrato do NIH dos EUA)
  • C2001P-CS3 (Outro identificador: National Cancer Institute)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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