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Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women Living With HIV (C-3001B-P-CS7)

1. september 2026 oppdatert av: UNC Lineberger Comprehensive Cancer Center

Comparison of Clinic-based Versus Clinic-plus Community Outreach-based Strategy Via HPV Self-Collection to Increase Uptake of Cervical Cancer Screening Among Women Living With HIV: a Cluster Randomized Trial (CASCADE-3001-B)

This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE)-3001-B trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of cervical cancer screening uptake among women living with HIV (WLWH). This study involves offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH.

The 'CASCADE' Network is a clinical trials network aimed at improving cervical cancer screening, management, and pre-cancer treatment for WLWH, in various healthcare settings. The network will conduct implementation trials to improve the triage of HPV-positive WLWH, as well as algorithms to optimize access to and options for effective treatment. Trials will be conducted using a mixed-methods approach aimed at assessing implementation strategies and outcomes and their potential to integrate into existing health systems.

Further understanding of HPV-based community-based strategies to reach WLWH, and the acceptability, feasibility, appropriateness, and cost of these strategies will be valuable for cervical cancer screening programs serving WLWH. Inputs from various 'CASCADE' Clinical Sites (CS) regarding feasible screening outreach options available in their settings for WLWH have guided this study that focuses on evaluating a pragmatic HPV self-collection implementation model to improve access to screening.

While it is clear that HPV self-collection is a highly acceptable and feasible screening option, creating opportunities to conduct self-collection in alternative venues outside the clinic premises, and with the guidance of and facilitation by trusted community healthcare workers (CHWs) is an important implementation strategy that needs to be evaluated and considered for its potential benefit. Studies have not yet evaluated a community-based approach for HPV self-collection kit distribution among WLWH - who may have different characteristics, preferences, and access to screening services than women not living with HIV. Providing WLWH with the option of receiving HPV self-collection kits in their own homes or other community-based settings ('community-based HPV self-collection') is a novel implementation strategy that could improve cervical cancer screening rates among eligible women. Therefore, this novel trial aims to evaluate the feasibility and effectiveness of implementing community-based HPV self-collection among WLWH.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The feasibility phase of the study is a parallel, 1:1, open label, cluster randomized trial to evaluate two implementation models to increase access to HPV self-collection for cervical cancer screening among WLWH. The main study phase of the C3001-B trial will include a total of 20 clinics which will be enrolled in a stepped-wedge cluster randomized into Models 1 and 2 as described below. The feasibility phase of the study (C3001B-P-CS7) will include a total of 6 clinics, and the main phase of the study, if approved, will include 20 clinics. Trial dates and sample sizes are estimated for 26 clinics total. The feasibility phase of the study is a parallel, 1:1, open label, cluster randomized trial to evaluate two implementation models to increase access to HPV self-collection for cervical cancer screening among WLWH.

Studietype

Intervensjonell

Registrering (Antatt)

17734

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Zimbabwe
      • Harare, Zimbabwe, 263-772287143
        • University of Zimbabwe Clinical Trials Research Centre
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bothwell T Guzha, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Clinic Inclusion Criteria

  • Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH.
  • These clinics should also have the ability to collect their own data.
  • Such clinics could be supported by national programs and bilateral donor-funded initiatives

Inclusion Criteria for Medical Record Abstraction

  • Are living with Human Immunodeficiency Virus (HIV)
  • Are 25-49 years of age, or as recommended by the Zimbabwe National Screening Guidelines
  • Live in the catchment areas of or attend a study-eligible clinic
  • Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because:
  • They have never undergone cervical cancer screening before, or
  • They have never undergone HPV-based testing before and are now due for Visual Inspection with Acetic Acid and Cervicography (VIAC), per national guidelines, or
  • They have previously undergone HPV-based testing, and are now due for follow-up HPV-based testing per national guidelines, and /or
  • They underwent ablative or excisional treatment for presumed or confirmed cervical dysplasia >1 year ago and have not had any follow-up cervical cancer screening since treatment.

Exclusion Criteria for Medical Record Abstraction

  • Have had their cervix removed
  • Are pregnant or <6 weeks post-delivery
  • Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral
  • Have previously been treated for invasive cervical cancer

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Deltakere påmeldt ved Modell 1-klinikker
Kvinner som lever med humant immunsviktvirus (WLWH) innskrevet ved Modell 1-klinikken.
Diagnostisk test: Model 1- Screening in Clinic Only
Model 1 involves only the recommended standard-of-care of cervical cancer screening Human Papillomavirus (HPV) self-collection, if available, or Visual Inspection with Acetic Acid and Cervicography (VIAC), if HPV-based testing is not available) to clients who are due for screening at clinics that distribute Antiretroviral Therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH). Efforts will be made to ensure availability of HPV kits for Model 1 clinics.
Eksperimentell: Participants enrolled at Model 2 Clinics
Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 2 Clinics.
Diagnostisk test: Model 2 - Screening in Clinic and Community
Model 2 will include clinic-based Human Papillomavirus (HPV) self-collection, as well as the implementation strategy of providing community-based distribution for HPV self-collection via Community Health workers (CHWs). Women living with Human Immunodeficiency Virus (WLWH) who are due and overdue for cervical cancer screening will be identified via line lists and appointment directories.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cervical cancer monthly screening rates
Tidsramme: Up to 1 month

Monthly cervical cancer screening rates among Women living with Human Immunodeficiency Virus (WLWH) will be compared between two models: (1) standard-of-care screening at static clinics only (Model 1) , and (2) Human Papillomavirus (HPV) self-collection offered at static clinics and through a community-based strategy by community health workers (CHWs)(Model 2).

Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid and Cervicography (VIAC) when HPV-based screening is not available.
Up to 1 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studieleder: Michael Hudgens, PhD, University of North Carolina, Chapel Hill
  • Studiestol: Jennifer Tang, MD, UNC Lineberger Comprehensive Cancer Center
  • Hovedetterforsker: Jennifer Smith, PhD, UNC Lineberger Comprehensive Cancer Center
  • Studieleder: Katie Mollan, PhD, University of North Carolina, Chapel Hill
  • Studieleder: Lameck Chinula, MD, University of North Carolina, Chapel Hill
  • Studieleder: Lisa Spees, PhD, University of North Carolina, Chapel Hill
  • Studieleder: Chemtai Mungo, MD MPH, University of North Carolina, Chapel Hill
  • Studieleder: Vikrant Sahasrabuddhe, MBBS, MPH, DrPH, Division of Cancer Prevention (DCP)
  • Studieleder: Sue Siminski, MS, MBA, Frontier Science Foundation
  • Studieleder: Zvavahera M Chirenje, MD, University of California, San Francisco

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

28. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-0894
  • U24CA275417 (U.S. NIH-stipend/kontrakt)
  • UG1CA275403 (U.S. NIH-stipend/kontrakt)
  • UG1CA284918 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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