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

Cervical Cancer Clinical Trial

— ASPIRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029794
• Other study ID #: H13-02627
• Status: Completed
• Phase: N/A
• First received: January 2, 2014
• Last updated: May 1, 2017
• Start date: March 2014
• Est. completion date: December 29, 2015

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 29, 2015
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.
• visual inspection with acetic acid (VIA)

Drug:
• 3-5% acetic acid

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Makerere University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy	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.	At the 12 month follow-up visit
Secondary	Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda	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.	One Year
Secondary	Prevalence rates of high-risk HPV in the self-collection arm.		One year
Secondary	Assess screen positive rates by nurse-midwife exam in VIA arm		One year
Secondary	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