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Lo studio clinico NCT07428330 (CASCADE3001A) per Cancro della cervice, Infezioni da HIV, Infezione da HPV è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV (CASCADE3001A) 1.600 Innovativo

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07428330 (CASCADE3001A) è uno studio interventistico per Cancro della cervice, Infezioni da HIV, Infezione da HPV, attualmente in arruolamento. Avviato il 3 febbraio 2026, prevede di arruolare 1.600 partecipanti. Sotto la guida di UNC Lineberger Comprehensive Cancer Center, dovrebbe concludersi entro il 1 settembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 febbraio 2026.
Sommario breve
This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE) -3001-A 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 HPV ...Mostra di più
Titolo ufficiale

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-A)

Patologie
Cancro della cerviceInfezioni da HIVInfezione da HPV
Altri ID dello studio
Numero NCT
NCT07428330
Data di inizio (effettiva)
2026-02-03
Ultimo aggiornamento pubblicato
2026-02-27
Data di completamento (stimata)
2027-09
Arruolamento (previsto)
1.600
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
screening
self-collection
Scopo principale
Selezione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleParticipants enrolled at Model 1 Clinics
Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 1 Clinic.
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 (VIA), 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...Mostra di più
SperimentaleParticipants enrolled at Model 2 Clinic s
Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 2 Clinics.
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 Facility-link facilitator (FLF)s. 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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Cervical cancer monthly screening rates
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 facility link facilitators (FLFs)(Model 2). Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid (VIA) when HPV-based screening is not available.
Up to 1 month
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto
Età minima
25 Years
Sessi idonei
Femmina

  • Are living with Human Immunodeficiency Virus (HIV)

  • Are 25-49 years of age, or as recommended by the Uganda's Ministry of Health Cervical Cancer Prevention and Control Guidelines

  • Live in the catchment areas of or attend a study-eligible clinic

  • Are eligible for Human Papillomavirus (HPV)-based cervico vaginal 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 Acetic Acid (VIA), 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.

  • Have had their cervix removed
  • Are pregnant or <3 months 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

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
UNC Lineberger Comprehensive Cancer Center logoUNC Lineberger Comprehensive Cancer Center
  • National Cancer Institute (NCI) logoIstituto nazionale dei tumori, Estados Unidos
  • National Institute on Minority Health and Health Disparities (NIMHD) logoNational Institute on Minority Health and Health Disparities (NIMHD)
Contatti principali dello studio
Contatto: Jennifer S Smith, PhD, 919-966-4432, [email protected]
Contatto: Franklin K Okwunze, MD, [email protected]
1 Centri dello studio in 1 paesi
Makerere University Walter Reed Program, Kampala, 16524, Uganda
Betty Mwesigwa, MD, Contatto, 256-312- 330400, [email protected]
Betty Mwesigwa, MD, Investigatore principale
In arruolamento