Cervical Cancer Screening in Cameroon

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401670
• Other study ID #: 2016-6070
• Secondary ID: 3P30CA013330
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 873
• Est. completion date: May 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 56 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• HIV/AIDS
• Uterine Cervical Neoplasms

Intervention

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].

Locations

Country	Name	City	State
Cameroon	Limbé Regional Hospital	Limbé

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Qualitative interviews to assess acceptability and feasibility of self-collection from women	To identify micro- and meso-level factors from an exploratory qualitative analysis using data obtained through focus group discussions and in-depth interviews to evaluate acceptability and feasibility of self-sampling for hrHPV testing among HIV[+] and HIV[-] women living in Limbé, Cameroon. This approach was used to better understand and describe women's knowledge, attitudes, and practices regarding cancers in general, cervical cancer, HPV infection, screening as well as behavioral and structural facilitators and barriers to cervical cancer prevention. Additional information was obtained to assess and compare perceptions and preferences for self-versus health provider-collected biological specimens to understand women's preferences given peculiar contextual factors that facilitate or inhibit access to cervical cancer screening for women at risk.	0 days