Cervical Cancer, HIV/AIDS
Conditions
Keywords
HIV, HPV screening, cervical cancer, self sampling, human papillomavirus
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.
Interventions
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.
BEHAVIORALHPV 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 \[Preventive Oncology International, Cleveland, OH, USA\].
Sponsors
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
The US pathologist was masked to the original cytologic interpretation but unmasked to being hrHPV positive to reduce influence of how the slides were read.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 56 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+ | 0 days | 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. |
| Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+ | 0 days | 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+. |
| Age-Specific Prevalence of Screen Positives in Limbé | 0 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews to assess acceptability and feasibility of self-collection from women | 0 days | 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. |
Countries
Cameroon
Outcome results
None listed