Cervical Cancer Screening in Cameroon

Albert Einstein College of Medicine

Status: Completed

Conditions: HIV/AIDS; Cervical Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04401670

3P30CA013330 (U.S. NIH Grant/Contract)

2016-6070

Details and patient eligibility

About

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.

Enrollment: 873 patients

Sex: Female

Ages: 25 to 56 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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873 participants in 1 patient group

Triage with different options

Other group

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)

Treatment:

Other: HPV screening and triage tests

Behavioral: HPV self-sampling