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Two-stage Cervical Cancer Screening Algorithms Using Primary hrHPV Testing in Botswana

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242823
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : September 13, 2021
Sponsor:
Collaborators:
University of Botswana
Botswana Harvard AIDS Institute Partnership
Information provided by (Responsible Party):
Rebecca Luckett, Beth Israel Deaconess Medical Center

Brief Summary:
Primary high-risk human papillomavirus (hrHPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of hrHPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary hrHPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and automated visual evaluation (AVE) for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for hrHPV self-testing in our setting. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.

Condition or disease Intervention/treatment Phase
Cervical Cancer Prevention Diagnostic Test: Automated visual evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in Botswana
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Baseline screening cohort
This group undergoes hrHPV self-swab and triage if positive. Triage evaluation occurs in all women and includes visual inspection with acetic acid, colposcopy and image capture for automated visual evaluation
Diagnostic Test: Automated visual evaluation
Participants will undergo primary hrHPV testing and if positive will be referred for VIA per Botswana and WHO guidelines. Participants will also undergo colposcopy, image capture for automated visual evaluation and biopsy at the time of VIA.




Primary Outcome Measures :
  1. Correlate results of self-collected vaginal swabs with provider collected specimens for hrHPV testing. [ Time Frame: 1 year ]
  2. Evaluate the sensitivity, specificity, positive and negative predictive value of primary hrHPV testing followed by visual inspection with acetic acid (VIA) [ Time Frame: 3 years ]
  3. Evaluate the sensitivity, specificity, positive and negative predictive value of primary hrHPV testing followed by colposcopy [ Time Frame: 3 years ]
  4. Evaluate the sensitivity, specificity, positive and negative predictive value of primary hrHPV testing followed by automated visual evaluation (AVE) [ Time Frame: 3 years ]
  5. Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. [ Time Frame: 3 years ]


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Ages Eligible for Study:   25 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis-gender female or transgender male are eligible if they have a cervix.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Cis-gender female or transgender male (must have a cervix)
  2. ≥25 years of age
  3. Competent to understand study procedures and give informed consent.

Exclusion Criteria:

  1. Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy)
  2. Previous hysterectomy
  3. Previous diagnosis of cervical cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242823


Contacts
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Contact: Rebecca Luckett, MD MPH 617-667-4165 rluckett@bidmc.harvard.edu
Contact: Annika Gompers, MPH 617-667-4165 agompers@bidmc.harvard.edu

Locations
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Botswana
Bamalete Lutheran Hospital Recruiting
Ramotswa, Botswana
Contact: Rebecca Luckett, MD MPH    +26774333773    rluckett@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
University of Botswana
Botswana Harvard AIDS Institute Partnership
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Responsible Party: Rebecca Luckett, Obstetrician Gynecologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04242823    
Other Study ID Numbers: 2019P001130
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases