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

NCT02029794 | Completed

• 1 other identifier: H13-02627
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

Cervical Cancer; Cervical Cancer Screening; Low Resource setting; HPV; Self-Collection; VIA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda

  One Year

• Prevalence rates of high-risk HPV in the self-collection arm.

  One year

• Assess screen positive rates by nurse-midwife exam in VIA arm

  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

  36 months

Study Arms (2)

HPV Self-collection

EXPERIMENTAL

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

Procedure: HPV self-colleciton

VIA arm

ACTIVE COMPARATOR

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); Drug: 3-5% acetic acid

Interventions

HPV self-colleciton 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.

Also known as: Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.

HPV Self-collection

visual inspection with acetic acid (VIA) PROCEDURE

Also known as: VIA conducted per standard of care.

VIA arm

3-5% acetic acid DRUG

VIA arm

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Makerere University: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Watchful Waiting; Acetic Acid

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Gina Ogilvie, MD FCFP DrPH

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gina Ogilvie

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 8, 2014
• Study Start: March 1, 2014
• Primary Completion: June 30, 2014
• Study Completion: December 29, 2015
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

CA (1)