Clinical trial NCT04401670: Cervical Cancer Screening in Cameroon
Official title: Cervical Cancer Screening Strategies in Women Living With HIV and HIV Uninfected Women in Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
HIV/AIDS
Keywords: HIV
HPV screening
cervical cancer
self sampling
human papillomavirus
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-05-26
Enrollment: 873
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+
timeFrame: 0 days
measure: Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+
timeFrame: 0 days
measure: Age-Specific Prevalence of Screen Positives in Limbé
timeFrame: 0 days
Secondary outcomes:
measure: Qualitative interviews to assess acceptability and feasibility of self-collection from women
timeFrame: 0 days
Other outcomes:
Locations:
city: Limbé
country: Cameroon
facility: Limbé Regional Hospital
Study officials:
affiliation: Albert Einstein College of Medicine
name: Philip E Castle
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Adebola Adedimeji
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.