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Cervical Cancer Screening in Cameroon

Primary Purpose

Cervical Cancer, HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
HPV screening and triage tests
HPV self-sampling
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring HIV, HPV screening, cervical cancer, self sampling, human papillomavirus

Eligibility Criteria

25 Years - 56 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women living in Limbe town and neighborhood
  • Confirmed to be HIV[+] or HIV[-]
  • Have never undergone cervical cancer screening, with no history of ICC
  • Willing and able to competently understand and provide written, informed paper-based consent
  • Women who are having a menstrual period will be deferred for 2 weeks from participating in the study

Exclusion Criteria:

  • Pregnant women
  • Women with signs of abnormalities
  • Non-menstrual bleeding suggestive of ICC
  • Without a cervix because they have undergone hysterectomy
  • Based on the judgment of the clinicians not sufficiently healthy to participate in a research study

Sites / Locations

  • Limbé Regional Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Triage with different options

Arm Description

Self-Collection: hrHPV and Biomarkers Testing (among hrHPV+) ThinPrep Specimen: Liquid-Based Cytology (LBC), hrHPV Testing, and Biomarker Testing (among hrHPV+) Visual Inspection after Acetic Acid (VIA)

Outcomes

Primary Outcome Measures

Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+
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+
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
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.

Secondary Outcome Measures

Qualitative interviews to assess acceptability and feasibility of self-collection from women
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.

Full Information

First Posted
May 18, 2020
Last Updated
May 22, 2020
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04401670
Brief Title
Cervical Cancer Screening in Cameroon
Official Title
Cervical Cancer Screening Strategies in Women Living With HIV and HIV Uninfected Women in Cameroon
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world. Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy, 2-3 generations of at-risk HIV[+] and HIV[-] women are already highly exposed to human papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine. Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is expensive and requires a complex clinical and lab infrastructure that does not generally exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily implemented, and effective cervical cancer screening methods are greatly needed in Sub-Saharan Africa, especially for HIV[+] women. This cervical cancer screening study of 1,200 women (800 HIV[+] and 400 HIV[-] women), aged 25-59 years, living in Cameroon, utilized our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women. All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of sensitivity, specificity, and positive and negative predictive value. The goal of this study was to establish the foundation and capacity for future studies designed to reduce the burden of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other countries with high HIV burdens on the best strategies for cervical cancer screening in their HIV[+] and HIV[-] women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, HIV/AIDS
Keywords
HIV, HPV screening, cervical cancer, self sampling, human papillomavirus

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study 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.
Allocation
N/A
Enrollment
873 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triage with different options
Arm Type
Other
Arm Description
Self-Collection: hrHPV and Biomarkers Testing (among hrHPV+) ThinPrep Specimen: Liquid-Based Cytology (LBC), hrHPV Testing, and Biomarker Testing (among hrHPV+) Visual Inspection after Acetic Acid (VIA)
Intervention Type
Other
Intervention Name(s)
HPV screening and triage tests
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HPV self-sampling
Intervention Description
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].
Primary Outcome Measure Information:
Title
Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+
Description
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.
Time Frame
0 days
Title
Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+
Description
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+.
Time Frame
0 days
Title
Age-Specific Prevalence of Screen Positives in Limbé
Description
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.
Time Frame
0 days
Secondary Outcome Measure Information:
Title
Qualitative interviews to assess acceptability and feasibility of self-collection from women
Description
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.
Time Frame
0 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women living in Limbe town and neighborhood Confirmed to be HIV[+] or HIV[-] Have never undergone cervical cancer screening, with no history of ICC Willing and able to competently understand and provide written, informed paper-based consent Women who are having a menstrual period will be deferred for 2 weeks from participating in the study Exclusion Criteria: Pregnant women Women with signs of abnormalities Non-menstrual bleeding suggestive of ICC Without a cervix because they have undergone hysterectomy Based on the judgment of the clinicians not sufficiently healthy to participate in a research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip E Castle
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adebola Adedimeji
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Limbé Regional Hospital
City
Limbé
Country
Cameroon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32676125
Citation
Castle PE, Ajeh R, Dzudie A, Kendowo E, Fuhngwa N, Simo-Wambo AG, Nsame D, Orock E, Hebert TM, Pierz AJ, Murokora D, Anastos K, Adedimeji A. A comparison of screening tests for detection of high-grade cervical abnormalities in women living with HIV from Cameroon. Infect Agent Cancer. 2020 Jul 11;15:45. doi: 10.1186/s13027-020-00311-w. eCollection 2020.
Results Reference
derived

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Cervical Cancer Screening in Cameroon

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