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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Cancer

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV Self-collection<br>Subjects will self-collect a cervical-vaginal sample. One time use. | Procedure: HPV self-colleciton<br>* 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.<br>* Other names: Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.;|
| Active Comparator: VIA arm<br>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)<br> <br> * Other names: VIA conducted per standard of care.;Drug: 3-5% acetic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the 12 month follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One Year | 
| Prevalence rates of high-risk HPV in the self-collection arm. |  | One year | 
| Assess screen positive rates by nurse-midwife exam in VIA arm |  | 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 |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Cervical Cancer, Cervical Cancer Screening, Low Resource setting, Self-Collection, VIA