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Completed

NCT Number: NCT02029794

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV self-colleciton

Procedure

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 names: Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.

Visual Inspection with Acetic Acid (VIA)

Procedure

Other names: VIA conducted per standard of care.

3-5% acetic acid

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Makerere University

Registry information

Official study 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

Acronym: ASPIRE

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 8, 2014
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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