ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer
This trial is active, not recruiting.
|Treatments||hpv self-colleciton, visual inspection with acetic acid (via), 3-5% acetic acid|
|Sponsor||University of British Columbia|
|Start date||March 2014|
|End date||May 2014|
|Trial size||500 participants|
|Trial identifier||NCT02029794, H13-02627|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy
time frame: At the 12 month follow-up visit
Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda
time frame: One Year
Prevalence rates of high-risk HPV in the self-collection arm.
time frame: One year
Assess screen positive rates by nurse-midwife exam in VIA arm
time frame: 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
time frame: 36 months
Female participants from 30 years up to 65 years old.
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
|Official title||ASPIRE Pilot: Determining Optimal Cervical Cancer Screening in a Low-resource Setting: A Randomized Controlled Trial Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid (VIA) Screening in Kampala, Uganda|
|Principal investigator||Gina Ogilvie, MD FCFP DrPH|
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