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

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ClinicalTrials.gov Identifier: NCT02029794
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Makerere University
Information provided by (Responsible Party):
Gina Ogilvie, 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: HPV self-colleciton Procedure: visual inspection with acetic acid (VIA) Drug: 3-5% acetic acid Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Study Start Date : March 2014
Actual Primary Completion Date : June 30, 2014
Actual Study Completion Date : December 29, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: HPV Self-collection
Subjects will self-collect a cervical-vaginal sample. One time use.
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.
Other Name: Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.

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
Procedure: visual inspection with acetic acid (VIA)
Other Name: VIA conducted per standard of care.

Drug: 3-5% acetic acid



Primary Outcome Measures :
  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 [ 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 Outcome Measures :
  1. 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.

  2. Prevalence rates of high-risk HPV in the self-collection arm. [ Time Frame: One year ]
  3. Assess screen positive rates by nurse-midwife exam in VIA arm [ Time Frame: One year ]
  4. 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 ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029794


Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Makerere University
Investigators
Principal Investigator: Gina Ogilvie, MD FCFP DrPH University of British Columbia

Responsible Party: Gina Ogilvie, Dr. Gina Ogilvie, University of British Columbia
ClinicalTrials.gov Identifier: NCT02029794     History of Changes
Other Study ID Numbers: H13-02627
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Gina Ogilvie, University of British Columbia:
Cervical Cancer
Cervical Cancer Screening
Low Resource setting
HPV
Self-Collection
VIA

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents