Urine HPV test per lo screening del cancro cervicale tra le donne che vivono con l'HIV in Sud Africa
Convalida delle prestazioni cliniche del test HPV nelle urine per lo screening del cancro cervicale tra le donne affette da HIV in Sud Africa
The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women.
Cervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Invasive cervical cancer is a significant health burden in low and middle income countries.
HIV-infected women in Africa are particularly affected and have an estimated invasive cervical cancer risk ~20-fold higher than women without HIV. Previous studies have been performed among only HIV-uninfected women or those whose HIV status was unknown. Additionally, HIV infected women are often diagnosed with invasive cervical cancer at younger ages.
Cervical cancer is preventable by regular screenings which includes doing a pap smear or HPV tests. There is also treatment of precancerous cervical lesions and vaccination against high risk types of HPV. World Health Organization currently recommends high risk HPV testing for cervical cancer screening in both high and low resources settings. National Guidelines in many low and middle income countries, including South Africa, have been updated to include plans to transition from cytology or visual screening to primary HPV screening. Urine HPV testing could provide a simpler approach for cervical screening that is more easily scaled in low and middle income countries.
The study hypothesizes that high-risk human papillomavirus (hrHPV) testing on urine specimens will be similar in sensitivity and specificity for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) compared to self- or clinician-collected sampling.
This study will investigate whether women can collect their own samples for HPV testing using either urine or a small brush in the vagina. The results of HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples will be compared to see which sample type works best.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Cheryl Hendrickson
- Numero di telefono: 919-843-2541
- Email: cheryl_hendrickson@med.unc.edu
Luoghi di studio
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Johannesburg
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Westdene, Johannesburg, Sud Africa, 2092
- Reclutamento
- Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
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Contatto:
- Sibusisiwe Luvuno
- Numero di telefono: +27-11-276-8800
- Email: sluvuno@witshealth.co.za
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Investigatore principale:
- Carla Chibwesha, MD, MSc
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Confirmed HIV-1 infection
- Age 25 years and older.
- Be willing and able to provide written informed consent.
Exclusion Criteria:
- Pregnant or intend to become pregnant within 90 days of enrollment
- Have been screened for cervical cancer within the preceding year (365 days)
- Have an active sexually transmitted infection (STI; women may participate once treated)
- Have a surgically absent cervix
- Have a history of cervical cancer
- have been vaccinated against HPV.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Single Arm
This is a single arm study. All participants will receive same interventions. |
Human papillomavirus (HPV) testing in urine sample. Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample. Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
Lasso di tempo: 4 weeks (Entry visit)
|
The clinical performance (sensitivity, specificity, positive predictive value, and negative predictive value) for CIN2+ detection of sample collection methods namely urine, self-collected samples, and provider-collected samples will be determined. |
4 weeks (Entry visit)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse
Lasso di tempo: 4 weeks
|
The clinical performance (sensitivity, specificity, positive predictive value, and negative predictive value) for CIN3+ detection or worse of sample collection methods namely urine, self-collected samples, and provider-collected samples will be determined. |
4 weeks
|
|
The proportion of participants positive for hrHPV
Lasso di tempo: 4 weeks
|
The high-risk human papillomavirus (hrHPV) positivity detection of urine, self-collected cervicovaginal specimen, and provider-collected cervical samples will be compared. |
4 weeks
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Carla Chibwesha, MD, MSc, Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie uterine
- Malattie genitali, femmina
- Neoplasie genitali, femmina
- Malattie della cervice uterina
- Neoplasie uterine
- Neoplasie cervicali uterine
Altri numeri di identificazione dello studio
- IGHID12022
- U54CA254564-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The rights and privacy of individuals who participate in research will be protected at all times. Thus, data intended for broader use will be stripped of identifiers that would permit linkages to individual research participants or variables that could lead to deductive disclosure of the identity of individual subjects. Research data that documents, supports and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .