Cervical CancerASPIRENCT02029794
ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer
A study testing HPV self-colleciton, visual inspection with acetic acid (VIA) and 3-5% acetic acid in people with Cervical Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV self-colleciton, visual inspection with acetic acid (VIA) and 3-5% acetic acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to 29 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known to be pregnant at study entry (self-reported)
- Complete hysterectomy
- Prior diagnosis or treatment of cervical dysplasia or cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cervical Cancer
- Being tested
- HPV self-colleciton, visual inspection with acetic acid (VIA), 3-5% acetic acid
- Keywords
- Cervical Cancer, Cervical Cancer Screening, Low Resource setting, HPV, Self-Collection, VIA
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV self-collecitonProcedure or surgery
Also called 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.
visual inspection with acetic acid (VIA)Procedure or surgery
Also called VIA conducted per standard of care.
3-5% acetic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| HPV Self-collection | Experimental | Subjects will self-collect a cervical-vaginal sample. One time use. Receives: Procedure: HPV self-colleciton |
| VIA arm | 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 Receives: Procedure: visual inspection with acetic acid (VIA); Drug: 3-5% acetic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the 12 month follow-up visit
Secondary outcomes (4)
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.
Measured: One Year
Prevalence rates of high-risk HPV in the self-collection arm.
Measured: One year
Assess screen positive rates by nurse-midwife exam in VIA arm
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startMar 2014
- Primary completion30 Jun 2014
- Study completion29 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University
- Responsible party
- Principal investigator, Gina Ogilvie, University of British Columbia
- Investigators
- Gina Ogilvie, MD FCFP DrPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029794
- Sponsor's protocol ID
- H13-02627
- Acronym
- ASPIRE
- Status last verified
- May 2017
- First submitted
- 2 Jan 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02029794
- Acronym / sponsor ID
- ASPIRE / H13-02627
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Cervical Cancer Screening, Low Resource setting, HPV, Self-Collection, VIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Makerere University
- Study start
- Mar 2014
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 29 Dec 2015 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV Self-collection | Experimental | Procedure: HPV self-collecitonSubjects will self-collect a cervical-vaginal sample. One time use. |
| VIA arm | Active comparator | Procedure: visual inspection with acetic acid (VIA), Drug: 3-5% acetic acidStandard 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Known to be pregnant at study entry (self-reported)
- Complete hysterectomy
- Prior diagnosis or treatment of cervical dysplasia or cervical cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV self-collecitonAlso: 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. | Procedure or surgery | HPV Self-collection |
| visual inspection with acetic acid (VIA)Also: VIA conducted per standard of care. | Procedure or surgery | VIA arm |
| 3-5% acetic acid | Drug | VIA arm |
Primary outcome
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.
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Ogilvie, MD FCFP DrPH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV self-colleciton, visual inspection with acetic acid (VIA) and 3-5% acetic acid in people with Cervical Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.