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

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)

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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