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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2014

Interventions

  • 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.
  • Procedure: visual inspection with acetic acid (VIA)
  • Drug: 3-5% acetic acid

Arms, Groups and Cohorts

  • Experimental: HPV Self-collection
    • Subjects will self-collect a cervical-vaginal sample. One time use.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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
  • Gender Eligibility: Female

    Minimum Age: 30 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • University of British Columbia
    • Collaborator
      • Makerere University
    • Provider of Information About this Clinical Study
      • Principal Investigator: Gina Ogilvie, Dr. Gina Ogilvie – University of British Columbia
    • Overall Official(s)
      • Gina Ogilvie, MD FCFP DrPH, Principal Investigator, University of British Columbia

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