CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 239 enrolled
Drug / intervention
2-stage screenother
Likely dose
Not stated in record
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Search/NCT03324009
NCT03324009N/ACompleted

Development of a Two-stage Cervical Cancer Screening Algorithm for Botswana

Beth Israel Deaconess Medical Center·interventional·Posted Oct 27, 2017·Updated May 5, 2020

In Brief

A clinical study evaluating 2-stage screen for Cervical Cancer and HIV/AIDS. Completed, enrolled 239 participants across 1 site.

Detailed Summary

Cervical cancer is the leading cause of cancer death among women in Botswana. The burden of cervical cancer is largely related to the high prevalence of HIV in Botswana (22%), as HIV is known to be a significant risk factor for cervical cancer. Cervical cancer screening is life-saving and has been shown to reduce cervical cancer incidence in multiple settings. Yet, there is no consensus on appropriate screening algorithms for women living with HIV, across resource settings. Botswana is in a unique position, relative to its neighbors in Sub-Saharan Africa, in that there exists capacity for advanced screening modalities, including primary high risk human papilloma virus (hrHPV) testing and cytology-based screening. To address this issue, this study seeks to evaluate two-stage cervical cancer screening algorithms for women living with HIV in Botswana using hrHPV testing. The protocols include hrHPV testing followed by Pap Smear evaluation, VIA and colposcopy. These same participants will be invited back at one-year for cervical cancer screening using hrHPV testing (followed by triage testing) in order to inform guidelines on the frequency of HPV testing in women living with HIV. The evidence generated will be critical to guiding cervical cancer screening in HIV-infected women across resource settings.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBotswana

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 27, 2017
Enrollment StartApr 20, 2018
Primary CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago

Interventions

2-stage screenother

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.