2-stage Cervical Cancer Screening in Botswana
|ClinicalTrials.gov Identifier: NCT03324009|
Recruitment Status : Not yet recruiting
First Posted : October 27, 2017
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer HIV/AIDS||Diagnostic Test: 2-stage screen||Not Applicable|
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 sensitivity, specificity, and positive predictive value (PPV) of two different two-stage cervical cancer screening algorithms for HIV-positive women in Botswana: HPV followed by Papanicolaou (Pap) smear, and HPV followed by visual inspection with acetic acid (VIA). The specific aims are:
- To determine the sensitivity, specificity, and PPV of a two-stage screening algorithm that utilizes HPV testing followed by Pap smear for the detection of high-grade cervical dysplasia, using colposcopy with histology as the gold standard.
- To determine the sensitivity, specificity, and PPV of a two-stage screening algorithm that utilizes HPV testing followed by VIA for the detection of high-grade cervical dysplasia, using colposcopy with histology as the gold standard.
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 the commercially-available Roche Cobas® HPV Assay. 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 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 both HPV/Pap and HPV/VIA two-stage algorithms while providing the highest-quality follow-up to cervical cancer screening abnormalities in Botswana.
Participants will thus have a total of two study-related encounters if they are HPV positive—one for initial HPV and Pap specimen collection and then one for VIA and colposcopy. Participants who are HPV negative and Pap smear negative will only have the one study-related initial screening visit. Participants who are HPV negative and Pap smear positive will be referred to colposcopy per Botswana cervical cancer screening protocol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cross-sectional study|
|Masking:||None (Open Label)|
|Official Title:||Development of a Two-stage Cervical Cancer Screening Algorithm for Botswana|
|Estimated Study Start Date :||May 2018|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: 2-stage screen
All patients will be enrolled in the two-stage cervical cancer screening protocol
Diagnostic Test: 2-stage screen
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.
- Performance of HPV-Pap screening algorithm [ Time Frame: 2 months ]Measurement of the sensitivity, specificity and positive predictive value of Pap smear in predicting cervical precancer and cancer in HPV positive, HIV positive women.
- Performance of HPV-VIA screening algorithm [ Time Frame: 2 months ]Measurement of the sensitivity, specificity and positive predictive value of VIA in predicting cervical precancer and cancer in HPV positive, HIV positive women.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324009
|Contact: Rebecca Luckett, MD MPH||+267 7433 email@example.com|
|Contact: Katharine Esselen, MD MBAfirstname.lastname@example.org|
|Principal Investigator:||Rebecca Luckett, MD MPH||Beth Israel Deaconess Medical Center|