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

NCT ID: NCT02029794

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-12-29

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

HPV Self-collection

Subjects will self-collect a cervical-vaginal sample. One time use.

Group Type: EXPERIMENTAL

HPV self-colleciton

Intervention Type: PROCEDURE

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.

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

Group Type: ACTIVE_COMPARATOR

visual inspection with acetic acid (VIA)

Intervention Type: PROCEDURE

3-5% acetic acid

Intervention Type: DRUG

Interventions

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.

Intervention Type: PROCEDURE

visual inspection with acetic acid (VIA)

Intervention Type: PROCEDURE

3-5% acetic acid

Intervention Type: DRUG

Other Intervention Names

Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.; VIA conducted per standard of care.

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Gina Ogilvie

Dr. Gina Ogilvie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gina Ogilvie, MD FCFP DrPH

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H13-02627

Identifier Type: -

Identifier Source: org_study_id