- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03324009
2-stage Cervical Cancer Screening in Botswana
Development of a Two-stage Cervical Cancer Screening Algorithm for Botswana
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Cervical cancer screening programs vary across settings and there is no clear guidance for effective screening programs for HIV-positive women. Evaluating the performance of algorithms that include human papillomavirus (HPV) DNA testing as first stage screening in high HIV prevalence settings like Botswana is essential for establishing an evidence-based strategy for cervical cancer screening in HIV-positive women.
This study seeks to evaluate the performance of two-stage cervical cancer screening algorithms using primary HPV testing in women living with HIV in Botswana. Second stage screening modalities include Papanicolaou (Pap) smear, visual inspection with acetic acid (VIA) and colposcopy.
The study will enroll 300 HIV positive women. For all 300 participants, gynecologic speculum exam will be performed and provider-collected cervical swabs will be collected for HPV testing and Pap smear preparation. HPV testing will be performed with either the commercially-available Cepheid Xpert® HPV Assay or a high throughput PCR platform. Pap smear will be prepared using standard technique at the site of collection.
Participants who test HPV-negative will have their Pap smear sent to the National Health Lab (NHL) for staining and pathologist evaluation. If the Pap smear is abnormal, they will be referred to colposcopy per current Botswana Cervical Cancer Prevention Guidelines.
Participants who test HPV-positive will also have their Pap smear reviewed, and will also be asked to return for colposcopy and will undergo further diagnosis and treatment for cervical cancer per national guidelines. At the colposcopy visit, a trained nurse will conduct VIA using the Botswana standard protocol. After application of acetic acid to the cervix, the nurse will record visual results as positive or negative. If VIA is positive based on assessment of the lesion(s), the nurse will record a recommendation for either cryotherapy or loop electrosurgical excision procedure (LEEP). Since all of these HPV-positive participants will undergo colposcopy, the participants will not be informed of the VIA results, as neither cryotherapy nor LEEP will be administered based on the VIA results. Rather, the participants will proceed to colposcopy and results of colposcopy will determine further diagnosis and treatment. This design enables us to assess the utility of the two-stage algorithms while providing the highest-quality follow-up to cervical cancer screening abnormalities in Botswana.
These same participants will be invited back at one-year for repeat cervical cancer screening using the same screening methods as at baseline. The data will inform guidelines on the frequency of hrHPV testing in women living with HIV.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Gaborone, Botswana
- Princess Marina Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- ≥25 years of age
- HIV-positive
- Competent to understand study procedures and give informed consent.
Exclusion Criteria:
- Currently pregnant
- Currently menstruating or having persistent vaginal discharge
- Previous hysterectomy
- Previous diagnosis of cervical cancer
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 2-stage screen
All patients will be enrolled in the two-stage cervical cancer screening protocol
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Pap smear is currently the standard of care for cervical cancer screening in Botswana.
In this study, participants will undergo HPV DNA testing at the time of Pap smear collection.
If HPV DNA test is positive, they will be referred for colposcopy.
Patients who have an HPV negative test but positive Pap smear will be referred for colposcopy per Botswana cervical cancer screening guidelines.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Performance of HPV-Pap screening algorithm
Aikaikkuna: 2 months
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Measurement of the sensitivity, specificity and positive predictive value of Pap smear in predicting cervical precancer and cancer in HPV positive, HIV positive women.
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2 months
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Performance of HPV-VIA screening algorithm
Aikaikkuna: 2 months
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Measurement of the sensitivity, specificity and positive predictive value of VIA in predicting cervical precancer and cancer in HPV positive, HIV positive women.
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2 months
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Performance of HPV-Colposcopy screening algorithm
Aikaikkuna: 6 months
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Measurement of the sensitivity, specificity and positive predictive value of Colposcopy in predicting cervical precancer and cancer in HPV positive, HIV positive women.
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6 months
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Incident and persistent HPV infection at one-year follow-up
Aikaikkuna: 18 months
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18 months
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Incidence, persistence and progression of histopathologic abnormality at one-year follow-up
Aikaikkuna: 18 months
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18 months
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Rebecca Luckett, MD MPH, Beth Israel Deaconess Medical Center
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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- Ginsburg O, Badwe R, Boyle P, Derricks G, Dare A, Evans T, Eniu A, Jimenez J, Kutluk T, Lopes G, Mohammed SI, Qiao YL, Rashid SF, Summers D, Sarfati D, Temmerman M, Trimble EL, Padela AI, Aggarwal A, Sullivan R. Changing global policy to deliver safe, equitable, and affordable care for women's cancers. Lancet. 2017 Feb 25;389(10071):871-880. doi: 10.1016/S0140-6736(16)31393-9. Epub 2016 Nov 1.
- Chatzistamatiou K, Moysiadis T, Angelis E, Kaufmann A, Skenderi A, Jansen-Duerr P, Lekka I, Kilintzis V, Angelidou S, Katsiki E, Hagemann I, Tsertanidou A, Koch I, Boecher O, Soutschek E, Maglaveras N, Agorastos T. Diagnostic accuracy of high-risk HPV DNA genotyping for primary cervical cancer screening and triage of HPV-positive women, compared to cytology: preliminary results of the PIPAVIR study. Arch Gynecol Obstet. 2017 May;295(5):1247-1257. doi: 10.1007/s00404-017-4324-x. Epub 2017 Mar 23.
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Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2017P000388
- 5P30AI060354-14 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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