Test urinaire du VPH pour le dépistage du cancer du col de l'utérus chez les femmes vivant avec le VIH en Afrique du Sud
Validation des performances cliniques du test urinaire du VPH pour le dépistage du cancer du col de l'utérus chez les femmes vivant avec le VIH en Afrique du Sud
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Cheryl Hendrickson
- Numéro de téléphone: 919-843-2541
- E-mail: cheryl_hendrickson@med.unc.edu
Lieux d'étude
-
-
Johannesburg
-
Westdene, Johannesburg, Afrique du Sud, 2092
- Recrutement
- Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
-
Contact:
- Sibusisiwe Luvuno
- Numéro de téléphone: +27-11-276-8800
- E-mail: sluvuno@witshealth.co.za
-
Chercheur principal:
- Carla Chibwesha, MD, MSc
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Carla Chibwesha, MD, MSc, Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies utérines
- Maladies génitales, femme
- Tumeurs génitales, femme
- Maladies du col de l'utérus
- Tumeurs utérines
- Tumeurs du col de l'utérus
Autres numéros d'identification d'étude
- IGHID12022
- U54CA254564-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .