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

N/ACompletedNCT02029794

University of British Columbia500 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

500

Conditions

Cervical Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At the 12 month follow-up visit

Secondary Outcomes

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

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.

Time frame: One Year

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