ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer (ASPIRE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02029794|
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Procedure: HPV self-colleciton Procedure: visual inspection with acetic acid (VIA) Drug: 3-5% acetic acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||June 30, 2014|
|Actual Study Completion Date :||December 29, 2015|
Experimental: HPV Self-collection
Subjects will self-collect a cervical-vaginal sample. One time use.
Procedure: HPV 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.
Other Name: Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.
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
Procedure: visual inspection with acetic acid (VIA)
Other Name: VIA conducted per standard of care.
Drug: 3-5% acetic acid
- 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.
- Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda [ Time Frame: 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. [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029794
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Gina Ogilvie, MD FCFP DrPH||University of British Columbia|