This trial is active, not recruiting.

Condition cervical cancer
Treatments hpv self-colleciton, visual inspection with acetic acid (via), 3-5% acetic acid
Sponsor University of British Columbia
Collaborator Makerere University
Start date March 2014
End date May 2014
Trial size 500 participants
Trial identifier NCT02029794, H13-02627


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Subjects will self-collect a cervical-vaginal sample. One time use.
hpv self-colleciton Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.
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.
(Active Comparator)
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
visual inspection with acetic acid (via) VIA conducted per standard of care.
3-5% acetic acid

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
time frame: At the 12 month follow-up visit

Secondary Outcomes

Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda
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
time frame: 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
time frame: 36 months

Eligibility Criteria

Female participants from 30 years up to 65 years old.

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

Additional Information

Official 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
Principal investigator Gina Ogilvie, MD FCFP DrPH
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.