NCT04401670

Cervical Cancer Screening in Cameroon

Cervical Cancer Screening Strategies in Women Living With HIV and HIV Uninfected Women in Cameroon

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 873 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 25 Years – 56 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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 \[Preventive Oncology International, Cleveland, OH, USA\].

Timeline

• Start date: 2017-04-25
• Primary completion: 2019-08-01
• Completion: 2020-05-01
• First posted: 2020-05-26
• Last updated: 2020-05-26

Locations

1 site across 1 country: Cameroon