Cervical Cancer Screening in Cameroon

NCT ID: NCT04401670

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 873 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2020-05-01

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.

Conditions

Cervical Cancer; HIV/AIDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Triage with different options

• 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)

Group Type: OTHER

HPV screening and triage tests

Intervention Type: OTHER

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.

HPV self-sampling

Intervention Type: BEHAVIORAL

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 \[Preventive Oncology International, Cleveland, OH, USA\].

Interventions

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.

Intervention Type: OTHER

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 \[Preventive Oncology International, Cleveland, OH, USA\].

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Adebola Adedimeji

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip E Castle

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Adebola Adedimeji

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Limbé Regional Hospital

Limbe, , Cameroon

Countries

Cameroon

References

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.

Reference Type: DERIVED

PMID: 32676125 (View on PubMed)

Other Identifiers

3P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-6070

Identifier Type: -

Identifier Source: org_study_id