Cervical Cancer
Conditions
Keywords
Cervical Cancer, Cervical Cancer Screening, Low Resource setting, HPV, Self-Collection, VIA
Brief summary
Cervical cancer remains a public health burden, particularly in developing countries such as sub-saharan Africa where the infrastructure for organized screening programs does not exist. As a result, other screening modalities (visual inspection with acetic acid) are the standard of care in such regions. It is now known, persistent infection with an oncogenic Human papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing HPV testing is a potential, safe and effective alternative to cytology testing (The Pap smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs. VIA in a cohort of women from Kisenyi, Uganda.
Interventions
PROCEDUREHPV self-colleciton
Women will self-collect a cervical sample that will be provided to an outreach worker and then labelled and sent to laboratories in Kampala for HPV testing. Women who test positive for HPV will be contacted by phone and provided with follow-up instructions.
DRUG3-5% acetic acid
Sponsors
Makerere University
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 30-65yrs * Living or working in community of Kisenyi, Uganda * Access to mobile telephone * Fluent in Luganda, Somali or English * Competent to provide informed consent
Exclusion criteria
* Known to be pregnant at study entry (self-reported) * Complete hysterectomy * Prior diagnosis or treatment of cervical dysplasia or cervical cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy | At the 12 month follow-up visit | Presence of low grade (CIN1) or moderate to high grade lesions (CIN2 or greater) will be compared between the two groups using chi-square testing at month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda | One Year | Proportion of women who provide HPV self collected specimen or who attend initial VIA will be compared between groups using Pearson's Chi-square test. Proportion of women who complete all recommended follow-up assessments and treatment (if required) will be compared between groups using chi-square testing. |
| Prevalence rates of high-risk HPV in the self-collection arm. | One year | — |
| Assess screen positive rates by nurse-midwife exam in VIA arm | One year | — |
| Evaluation of adverse events or complications documented at time of sample collection, 4-6 weeks after cryotherapy and at 12 and 36 months by study questionnaire | 36 months | — |
Countries
Canada
Outcome results
None listed