Cervical Cancer Screening in Cameroon

NCT04401670 | Completed

• 2 other identifiers: 2016-60703P30CA013330
• Study Type: interventional
• Target: 873
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; HPV screening; cervical cancer; self sampling; human papillomavirus

Outcome Measures

Primary Outcomes (3)

• 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.

  0 days

• 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+.

  0 days

• 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.

  0 days

Secondary Outcomes (1)

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

  0 days

Study Arms (1)

Triage with different options

OTHER

* 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)

Other: HPV screening and triage tests; Behavioral: HPV self-sampling

Interventions

HPV screening and triage tests 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.

Triage with different options

HPV self-sampling 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 \[Preventive Oncology International, Cleveland, OH, USA\].

Triage with different options

Eligibility Criteria

• Age: 25 Years - 56 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Limbé Regional Hospital

Limbe, Cameroon

Location

Related Publications (1)

• 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.

  PMID: 32676125 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Philip E Castle

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Adebola Adedimeji

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 26, 2020
• Study Start: April 25, 2017
• Primary Completion: August 1, 2019
• Study Completion: May 1, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)