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
Overview
- Phase
- Not Applicable
- Intervention
- HPV self-colleciton
- Conditions
- Cervical Cancer
- Sponsor
- University of British Columbia
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Gina Ogilvie
Dr. Gina Ogilvie
University of British Columbia
Eligibility Criteria
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
Arms & Interventions
HPV Self-collection
Subjects will self-collect a cervical-vaginal sample. One time use.
Intervention: HPV self-colleciton
VIA arm
Standard of care in Uganda is visual inspection with acetic acid (VIA). Women randomized to this arm will undergo the following: Cervix examined by clinician using speculum and light source. Cervix then sprayed with 3-5% acetic acid, and then lesions described one minute after application of acetic acid. VIA negative no acetowhite lesions detected; positive is when dense aceto-white lesions are seen touching squamocolumnar junction
Intervention: visual inspection with acetic acid (VIA)
VIA arm
Standard of care in Uganda is visual inspection with acetic acid (VIA). Women randomized to this arm will undergo the following: Cervix examined by clinician using speculum and light source. Cervix then sprayed with 3-5% acetic acid, and then lesions described one minute after application of acetic acid. VIA negative no acetowhite lesions detected; positive is when dense aceto-white lesions are seen touching squamocolumnar junction
Intervention: 3-5% acetic acid
Outcomes
Primary Outcomes
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
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 Outcomes
- Prevalence rates of high-risk HPV in the self-collection arm.(One year)
- Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda(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)
- Assess screen positive rates by nurse-midwife exam in VIA arm(One year)