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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
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The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope
Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. Visual Inspection with Lugol's Iodine (VILI): After imaging with Acetic acid, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Lesion location(s) will be noted on a clock-face diagram and used to direct biopsy if a lesion is present or random biopsies will be obtained from two quadrants in the absence of a visible lesion. |
|
| Pocket Colposcope | Experimental | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. Pocket-Assisted Visual Inspection with Lugol's Iodine (PA-VILI): After imaging with AA, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Images will be acquired. A biopsy will be obtained using the pocket. Random biopsies will be obtained from 2 quadrants in the absence of a visible lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pocket Colposcope | Device | Both arms will receive treatment in order to prevent cervical cancer. However, the intervention using the pocket colposcope device will be used on half the enrolled subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Exams With Lesions Identified | The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions. | Baseline |
| Sensitivity | Sensitivity of Pocket vs VIA | Baseline |
| Specificity | Specificity of Pocket vs VIA | Baseline |
| Negative Predictive Value (NPV) | Negative predictive value (NPV) of Pocket vs VIA | Baseline |
| Positive Predictive Value (PPV) | Positive predictive value (PPV) of Pocket vs VIA | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire | Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit. | baseline |
| Percent of Providers Who Reported Experiencing no Challenges During the Exam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Huchko, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Nairobi | Kenya |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pocket Colposcope | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. |
| FG001 | Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. |
| FG002 | Mis-weighted Randomization to Pocket Colposcope | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. |
| FG003 | Mis-weighted Randomization to Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pocket Colposcope | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Exams With Lesions Identified | The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions. | Participants who completed the study | Posted | Number | 95% Confidence Interval | percent of exams | Baseline | Exams | Exams |
|
During baseline visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pocket Colposcope | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Huchko, MD, MPH | Duke University Medical Center | (919) 684-8111 | megan.huchko@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2024 | Jun 5, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Standard of Care Colposcopy | Procedure | VIA and VILI as previously described, |
|
Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'. |
| baseline |
| Percent of Participants Who Reported Experiencing Pain During Their Exam | Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?" | Baseline |
| Percent of Participants Who Expressed Confidence in Their Provider's Assessment | Participant perspective of the exam was assessed by asking "How confident are you in the provider's assessment from today's visit?" | Baseline |
| Percent of Participants Who Would Recommend the Exam to a Friend | Participant perspective of the exam was assessed by asking "How likely would you recommend this medical exam to a friend?" | Baseline |
| BG001 | Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. |
| BG002 | Mis-weighted Randomization to Pocket Colposcope | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. |
| BG003 | Mis-weighted Randomization to Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. |
| OG002 | Mis-weighted Randomization to Pocket Colposcope | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. |
| OG003 | Mis-weighted Randomization to Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. |
|
|
| Primary | Sensitivity | Sensitivity of Pocket vs VIA | Participants with biopsy results | Posted | Number | percent | Baseline |
|
|
|
| Primary | Specificity | Specificity of Pocket vs VIA | Participants with biopsy results | Posted | Number | percent | Baseline |
|
|
|
| Primary | Negative Predictive Value (NPV) | Negative predictive value (NPV) of Pocket vs VIA | Participants with biopsy results | Posted | Number | percentage | Baseline |
|
|
|
| Primary | Positive Predictive Value (PPV) | Positive predictive value (PPV) of Pocket vs VIA | Participants with biopsy results | Posted | Number | percentage | Baseline |
|
|
|
| Secondary | Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire | Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit. | Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report. | Posted | Number | percent of participants | baseline |
|
|
|
| Secondary | Percent of Providers Who Reported Experiencing no Challenges During the Exam | Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'. | Provider surveys for participants who completed the study. Provider survey data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report. | Posted | Number | percent | baseline |
|
|
|
| Secondary | Percent of Participants Who Reported Experiencing Pain During Their Exam | Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?" | Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report. | Posted | Number | percent of participants | Baseline |
|
|
|
| Secondary | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | Participant perspective of the exam was assessed by asking "How confident are you in the provider's assessment from today's visit?" | Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report. | Posted | Number | percent of participants | Baseline |
|
|
|
| Secondary | Percent of Participants Who Would Recommend the Exam to a Friend | Participant perspective of the exam was assessed by asking "How likely would you recommend this medical exam to a friend?" | Participants who completed the questionnaire. Questionnaire data were not collected for the two mis-weighted randomization arms due to a lengthy enrollment pause prior to those arms being enrolled, as well as the randomization error. No data were collected from participants in the mis-weighted randomization arms, and there is no data to report. | Posted | Number | percent of participants | Baseline |
|
|
|
| 0 |
| 196 |
| 0 |
| 196 |
| 0 |
| 196 |
| EG001 | Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. | 0 | 208 | 0 | 208 | 0 | 208 |
| EG002 | Mis-weighted Randomization to Pocket Colposcope | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Mis-weighted Randomization to Standard of Care (VIA) | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Somewhat |
|
| Very much |
|
| Somewhat |
|
| Very much |
|
| Likely |
|
| Very likely |
|