Cervical Cancer Screening in Cameroon
Condition: Cervical Cancer; HIV/AIDS
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

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.
    


Intervention name(s): HPV screening and triage tests; HPV self-sampling
Intervention type(s): Other; Behavioral
Intervention description(s): 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.; 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HIV; HPV screening; cervical cancer; self sampling; human papillomavirus