ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: HPV self-colleciton; Procedure: visual inspection with acetic acid (VIA); Drug: 3-5% acetic acid

• Registration Number: NCT02029794
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Study Start: 2014-03
• Primary Completion: 2014-06-30
• Study Completion: 2015-12-29
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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

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Exclusion Criteria

• Known to be pregnant at study entry (self-reported)
• Complete hysterectomy
• Prior diagnosis or treatment of cervical dysplasia or cervical cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV Self-collection	HPV self-colleciton	Subjects will self-collect a cervical-vaginal sample. One time use.
VIA arm	visual inspection with acetic acid (VIA)	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
VIA arm	3-5% acetic acid	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	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.
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

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada