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

University of British Columbia logo

University of British Columbia

Status

Completed

Conditions

Cervical Cancer

Treatments

Procedure: HPV self-colleciton
Drug: 3-5% acetic acid
Procedure: visual inspection with acetic acid (VIA)

Study type

Interventional

Funder types

Other

Identifiers

NCT02029794
H13-02627

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

Female

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

HPV Self-collection
Experimental group
Description:
Subjects will self-collect a cervical-vaginal sample. One time use.
Treatment:
Procedure: HPV self-colleciton
VIA arm
Active Comparator group
Description:
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
Treatment:
Procedure: visual inspection with acetic acid (VIA)
Drug: 3-5% acetic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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