Cervical Cancer Screening in Cameroon
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|ClinicalTrials.gov Identifier: NCT04401670|
Recruitment Status : Completed
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer HIV/AIDS||Other: HPV screening and triage tests Behavioral: HPV self-sampling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||873 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||The US pathologist was masked to the original cytologic interpretation but unmasked to being hrHPV positive to reduce influence of how the slides were read.|
|Official Title:||Cervical Cancer Screening Strategies in Women Living With HIV and HIV Uninfected Women in Cameroon|
|Actual Study Start Date :||April 25, 2017|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||May 1, 2020|
Triage with different options
Other: HPV screening and triage tests
The participants underwent a pelvic exam to have a provider-collected sample placed in PreservCyt [Hologic, Inc., Bedford, MA, USA] and a visual inspection by acetic acid (VIA) by a nurse.
Behavioral: HPV self-sampling
The participant was escorted by the nurse to a private room and given instructions on how to self-collect their sample using "Just for Me" sampler [Preventive Oncology International, Cleveland, OH, USA].
- Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+ [ Time Frame: 0 days ]To evaluate and compare the clinical performance of high-risk human papillomavirus (hrHPV) DNA testing using provider-collected specimens (Provider/hrHPV) and self-collected specimens (Self/hrHPV), visual inspection after acetic acid (VIA), and liquid-based cytology (LBC) for detection of cervical intraepithelial neoplasia (CIN) grade 2 or more severe diagnoses (CIN2+) and grade 3 or more severe diagnoses (CIN3+) in HIV[+] and HIV[-] women.
- Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+ [ Time Frame: 0 days ]To compare the clinical performance of VIA, detection of the most carcinogenic hrHPV genotypes HPV16, 18, or/and 45, and biomarkers Ki-67, p16INK4a, and TOP2A mRNA, HPV viral load, and LBC as triage strategies for hrHPV-positive women for detection of CIN2+ and CIN3+.
- Age-Specific Prevalence of Screen Positives in Limbé [ Time Frame: 0 days ]To measure the age-group specific prevalence of hrHPV DNA, LBC, and VIA positivity, and CIN2+ and CIN3+ in HIV[+] and HIV[-] women living in Limbé, Cameroon.
- Qualitative interviews to assess acceptability and feasibility of self-collection from women [ Time Frame: 0 days ]To identify micro- and meso-level factors from an exploratory qualitative analysis using data obtained through focus group discussions and in-depth interviews to evaluate acceptability and feasibility of self-sampling for hrHPV testing among HIV[+] and HIV[-] women living in Limbé, Cameroon. This approach was used to better understand and describe women's knowledge, attitudes, and practices regarding cancers in general, cervical cancer, HPV infection, screening as well as behavioral and structural facilitators and barriers to cervical cancer prevention. Additional information was obtained to assess and compare perceptions and preferences for self-versus health provider-collected biological specimens to understand women's preferences given peculiar contextual factors that facilitate or inhibit access to cervical cancer screening for women at risk.
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): NCT04401670
|Limbé Regional Hospital|
|Principal Investigator:||Philip E Castle||Albert Einstein College of Medicine|
|Principal Investigator:||Adebola Adedimeji||Albert Einstein College of Medicine|