- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02029794
ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer (ASPIRE)
May 1, 2017 updated by: Gina Ogilvie, University of British Columbia
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- University of British Columbia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HPV Self-collection
Subjects will self-collect a cervical-vaginal sample.
One time use.
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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.
Other Names:
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Active Comparator: 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
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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At the 12 month follow-up visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda
Time Frame: One Year
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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.
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One Year
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Prevalence rates of high-risk HPV in the self-collection arm.
Time Frame: One year
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One year
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Assess screen positive rates by nurse-midwife exam in VIA arm
Time Frame: One year
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One year
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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
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36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gina Ogilvie, MD FCFP DrPH, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
June 30, 2014
Study Completion (Actual)
December 29, 2015
Study Registration Dates
First Submitted
January 2, 2014
First Submitted That Met QC Criteria
January 7, 2014
First Posted (Estimate)
January 8, 2014
Study Record Updates
Last Update Posted (Actual)
May 3, 2017
Last Update Submitted That Met QC Criteria
May 1, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Anticarcinogenic Agents
- Acetic Acid
- Retinol acetate
Other Study ID Numbers
- H13-02627
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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