Cervical Intraepithelial NeoplasiaSAVENCT02237326
Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
A study testing Visual Inspection with Acetic Acid and Visual Inspection with Lugol's Iodine in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
The clinical trial is part of a larger study to evaluate the safety and efficacy of screening techniques for cervical cancer among HIV-infected women. The investigators randomized women to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with Lugol's Iodine (VILI), along with a… Read more about this study
- Who is it for?
- Ages 23 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Cancer, HIV
- What is being tested?
- Visual Inspection with Acetic Acid and Visual Inspection with Lugol's Iodine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2011to Oct 2012
- 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 23 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 23-59
- Intact cervix/uterus
- no evidence of infection
- ability to provide informed consent
Who cannot join
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Validity Evaluation for Cervical Cancer Screening and Treatment Techniques Among HIV-infected Women
The clinical trial is part of a larger study to evaluate the safety and efficacy of screening techniques for cervical cancer among HIV-infected women. The investigators randomized women to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were based on the colposcopy exam done at the study visit. The investigators then compared outcomes between the two groups to assess the test characteristics of both VIA and VILI.
Read the detailed description
Cervical cancer and HIV are intersecting epidemics that both disproportionately affect low-income women; the impact of the socioeconomic disparity and biologic synergy of these two diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer killer. HIV-infected women are at increased risk for the development of cervical precancer and cancer, develop more aggressive lesions and are affected at younger ages. Although screening for and treatment of precancer has reduced the incidence of cervical cancer to close to zero in resource-rich countries, strategies are costly and not available in most resource-limited countries. Novel testing and treatment methods that can be carried out in low-resource settings are urgently needed to prevent cervical cancer in these settings, especially among HIV-infected women. Using a cross-sectional study design, the investigators tested two potentially low-cost and effective cervical cancer screening methods: visual inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of cervical dysplasia, neither of which have been well-studied in HIV-infected women. Investigators also randomized a small subset of women to undergo VIA compared to Visual Inspection with Lugol's Iodine (VILI) to compare the test characteristics of these two screening exams. In addition, remarkably little is known about the potential impact of the presence, diagnosis and treatment of human papillomavirus-related dysplasia on HIV genital shedding, a major risk factor for HIV transmission. To explore the impact of the presence, diagnosis and treatment of human papillomavirus-related cervical dysplasia on HIV-1 in genital secretions, investigators compared the levels of HIV-1 RNA found in the cervicovaginal secretions of women with no evidence of cervical dysplasia to levels in women with high-grade cervical dysplasia. They also compared the levels of HIV-1 RNA prior to and after cervical biopsy as well as up to 14 weeks after standard treatment for cervical dysplasia using loop electrosurgical excision procedure (LEEP). Results from this study will inform the prioritization and design of safe, effective and low-cost cervical cancer screening and prevention programs for HIV-infected
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Cancer, HIV
- Being tested
- Visual Inspection with Acetic Acid, Visual Inspection with Lugol's Iodine
- Keywords
- Visual Inspection with Acetic Acid, Visual Inspection with Lugol's Iodine, Cervical Intraepithelial neoplasia, Cervical Cancer Screening, HIV infected women
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Inspection with Acetic AcidProcedure or surgery
Visual Inspection with Acetic Acid is the application of acetic acid to a cervix, followed by examination with a light source. It is not a new drug or device, and has been used in resource-limited settings for several decades. The purpose of this trial is to compare the two screening techniques, which had not been done previously.
Visual Inspection with Lugol's IodineProcedure or surgery
Visual Inspection with Lugol's Iodine is the application of lugol's iodine to a woman's cervix, followed by examination with a light source with the goal of detecting precancerous lesions. Like Visual Inspection with Acetic Acid, it is not a new drug or device.
| Study group | Role | What they receive |
|---|---|---|
| Visual Inspection with Lugol's Iodine | Active comparator | Participants underwent colposcopic exam, followed by Visual Inspection with Lugol's Iodine (VILI) by a second, blinded clinician (the order of exams was reversed to eliminate potential interference with exam results due to iodine staining). Biopsy was done after the VILI. Receives: Procedure: Visual Inspection with Lugol's Iodine |
| Visual Inspection with Acetic Acid | Active comparator | Participants underwent Visual Inspection with Acetic Acid followed by colposcopy by a second clinician who was blinded to the screening test result. Receives: Procedure: Visual Inspection with Acetic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Positivity Rate
Investigators compared the test positivity between VIA and VILI.
Measured: eight months
Secondary outcomes (1)
Sensitivity
Investigators compared the sensitivity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237326
- Sponsor's protocol ID
- SSC 1825
- Other IDs
- 10-00197
- Acronym
- SAVE
- Status last verified
- Sep 2014
- First submitted
- 3 Sep 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Huchko MJ, Sneden J, Zakaras JM, Smith-McCune K, Sawaya G, Maloba M, Bukusi EA, Cohen CR. A randomized trial comparing the diagnostic accuracy of visual inspection with acetic acid to Visual Inspection with Lugol's Iodine for cervical cancer screening in HIV-infected women. PLoS One. 2015 Apr 7;10(4):e0118568. doi: 10.1371/journal.pone.0118568. eCollection 2015.
PubMed 25849627
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Validity Evaluation for Cervical Cancer Screening and Treatment Techniques Among HIV-infected Women
- ClinicalTrials.gov ID
- NCT02237326
- Acronym / sponsor ID
- SAVE / SSC 1825
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Cancer, HIV
- Keywords
- Visual Inspection with Acetic Acid, Visual Inspection with Lugol's Iodine, Cervical Intraepithelial neoplasia, Cervical Cancer Screening, HIV infected women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Sep 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.
The clinical trial is part of a larger study to evaluate the safety and efficacy of screening techniques for cervical cancer among HIV-infected women. The investigators randomized women to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were based on the colposcopy exam done at the study visit. The investigators then compared outcomes between the two groups to assess the test characteristics of both VIA and VILI.
Detailed description
Cervical cancer and HIV are intersecting epidemics that both disproportionately affect low-income women; the impact of the socioeconomic disparity and biologic synergy of these two diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer killer. HIV-infected women are at increased risk for the development of cervical precancer and cancer, develop more aggressive lesions and are affected at younger ages. Although screening for and treatment of precancer has reduced the incidence of cervical cancer to close to zero in resource-rich countries, strategies are costly and not available in most resource-limited countries. Novel testing and treatment methods that can be carried out in low-resource settings are urgently needed to prevent cervical cancer in these settings, especially among HIV-infected women. Using a cross-sectional study design, the investigators tested two potentially low-cost and effective cervical cancer screening methods: visual inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of cervical dysplasia, neither of which have been well-studied in HIV-infected women. Investigators also randomized a small subset of women to undergo VIA compared to Visual Inspection with Lugol's Iodine (VILI) to compare the test characteristics of these two screening exams. In addition, remarkably little is known about the potential impact of the presence, diagnosis and treatment of human papillomavirus-related dysplasia on HIV genital shedding, a major risk factor for HIV transmission. To explore the impact of the presence, diagnosis and treatment of human papillomavirus-related cervical dysplasia on HIV-1 in genital secretions, investigators compared the levels of HIV-1 RNA found in the cervicovaginal secretions of women with no evidence of cervical dysplasia to levels in women with high-grade cervical dysplasia. They also compared the levels of HIV-1 RNA prior to and after cervical biopsy as well as up to 14 weeks after standard treatment for cervical dysplasia using loop electrosurgical excision procedure (LEEP). Results from this study will inform the prioritization and design of safe, effective and low-cost cervical cancer screening and prevention programs for HIV-infected
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Inspection with Lugol's Iodine | Active comparator | Procedure: Visual Inspection with Lugol's IodineParticipants underwent colposcopic exam, followed by Visual Inspection with Lugol's Iodine (VILI) by a second, blinded clinician (the order of exams was reversed to eliminate potential interference with exam results due to iodine staining). Biopsy was done after the VILI. |
| Visual Inspection with Acetic Acid | Active comparator | Procedure: Visual Inspection with Acetic AcidParticipants underwent Visual Inspection with Acetic Acid followed by colposcopy by a second clinician who was blinded to the screening test result. |
Who may qualify
- Ages
- 23 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 23-59
- Intact cervix/uterus
- no evidence of infection
- ability to provide informed consent
Key exclusion criteria (1 listed)
- pregnant
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 |
|---|---|---|
| Visual Inspection with Acetic AcidVisual Inspection with Acetic Acid is the application of acetic acid to a cervix, followed by examination with a light source. It is not a new drug or device, and has been used in resource-limited settings for several decades. The purpose of this trial is to compare the two screening techniques, which had not been done previously. | Procedure or surgery | Visual Inspection with Acetic Acid |
| Visual Inspection with Lugol's IodineVisual Inspection with Lugol's Iodine is the application of lugol's iodine to a woman's cervix, followed by examination with a light source with the goal of detecting precancerous lesions. Like Visual Inspection with Acetic Acid, it is not a new drug or device. | Procedure or surgery | Visual Inspection with Lugol's Iodine |
Primary outcome
Test Positivity Rate
Time frame: eight months
Investigators compared the test positivity between VIA and VILI.
1 secondary outcome
Sensitivity
Time frame: 12 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 11 Sep 2014.
- Derived from this study: PubMed 25849627Huchko MJ, Sneden J, Zakaras JM, Smith-McCune K, Sawaya G, Maloba M, Bukusi EA, Cohen CR. A randomized trial comparing the diagnostic accuracy of visual inspection with acetic acid to Visual Inspection with Lugol's Iodine for cervical cancer screening in HIV-infected women. PLoS One. 2015 Apr 7;10(4):e0118568. doi: 10.1371/journal.pone.0118568. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Inspection with Acetic Acid and Visual Inspection with Lugol's Iodine in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by University of California, San Francisco at 1 site in Kenya.
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 4 inclusion and 1 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 11 Sep 2014. 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 Kenya. 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?
Test Positivity Rate (time frame: eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237326, which also lists 1 linked publication.
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 11 Sep 2014.