Cervical Cancer, HIV Infections, HPV Infection
Conditions
Keywords
cervical cancer screening, Pap smear, Colposcopy, Pap smear, colposcopy
Brief summary
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
Detailed description
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.
Interventions
PROCEDUREStandard of Care Colposcopy
VIA and VILI as previously described,
DEVICEPocket Colposcope
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.
Sponsors
Kenya Medical Research Institute
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 25 years old and \< 65 years old 2. Sex: Female 3. Positive HPV test within past 6 months 4. HIV+ women
Exclusion criteria
1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated) 2. Women with a negative HPV test 3. Patients incapable of giving informed consent 4. Women with a history of cervical cancer 5. Pelvic exam concerning for cervical cancer or cervical infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) | Baseline | Positive predictive value (PPV) of Pocket vs VIA |
| Percent of Exams With Lesions Identified | Baseline | The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions. |
| Sensitivity | Baseline | Sensitivity of Pocket vs VIA |
| Specificity | Baseline | Specificity of Pocket vs VIA |
| Negative Predictive Value (NPV) | Baseline | Negative predictive value (NPV) of Pocket vs VIA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire | baseline | Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit. |
| Percent of Providers Who Reported Experiencing no Challenges During the Exam | baseline | Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'. |
| Percent of Participants Who Reported Experiencing Pain During Their Exam | Baseline | Participant perspective of the exam was assessed by asking Did you experience any pain throughout your exam? |
| Percent of Participants Who Expressed Confidence in Their Provider's Assessment | Baseline | Participant perspective of the exam was assessed by asking How confident are you in the provider's assessment from today's visit? |
| Percent of Participants Who Would Recommend the Exam to a Friend | Baseline | Participant perspective of the exam was assessed by asking How likely would you recommend this medical exam to a friend? |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 196 |
| 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. | 208 |
| 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. | 11 |
| 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. | 19 |
| Total | 434 |
Baseline characteristics
| Characteristic | Pocket Colposcope | Standard of Care (VIA) | Mis-weighted Randomization to Pocket Colposcope | Mis-weighted Randomization to Standard of Care (VIA) | Total |
|---|---|---|---|---|---|
| Age, Customized 25-34 years old | 49 Participants | 56 Participants | 2 Participants | 3 Participants | 110 Participants |
| Age, Customized 35-44 years old | 87 Participants | 81 Participants | 2 Participants | 6 Participants | 176 Participants |
| Age, Customized 45-54 years old | 45 Participants | 46 Participants | 5 Participants | 8 Participants | 104 Participants |
| Age, Customized 55-65 years old | 15 Participants | 25 Participants | 2 Participants | 2 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 196 Participants | 208 Participants | 0 Participants | 0 Participants | 404 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 11 Participants | 19 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 196 Participants | 208 Participants | 11 Participants | 19 Participants | 434 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 196 Participants | 208 Participants | 11 Participants | 19 Participants | 434 Participants |
| Sex: Female, Male Female | 196 Participants | 208 Participants | 11 Participants | 19 Participants | 434 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 196 | 0 / 208 | 0 / 11 | 0 / 19 |
| other Total, other adverse events | 0 / 196 | 0 / 208 | 0 / 11 | 0 / 19 |
| serious Total, serious adverse events | 0 / 196 | 0 / 208 | 0 / 11 | 0 / 19 |
Outcome results
Primary
Negative Predictive Value (NPV)
Negative predictive value (NPV) of Pocket vs VIA
Time frame: Baseline
Population: Participants with biopsy results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pocket Colposcope | Negative Predictive Value (NPV) | 82.9 percentage |
| Standard of Care (VIA) | Negative Predictive Value (NPV) | 87.1 percentage |
Primary
Percent of Exams With Lesions Identified
The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Time frame: Baseline
Population: Participants who completed the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pocket Colposcope | Percent of Exams With Lesions Identified | 14.3 percent of exams |
| Standard of Care (VIA) | Percent of Exams With Lesions Identified | 17.3 percent of exams |
| Mis-weighted Randomization to Pocket Colposcope | Percent of Exams With Lesions Identified | 0 percent of exams |
| Mis-weighted Randomization to Standard of Care (VIA) | Percent of Exams With Lesions Identified | 21.1 percent of exams |
Primary
Positive Predictive Value (PPV)
Positive predictive value (PPV) of Pocket vs VIA
Time frame: Baseline
Population: Participants with biopsy results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pocket Colposcope | Positive Predictive Value (PPV) | 37.5 percentage |
| Standard of Care (VIA) | Positive Predictive Value (PPV) | 20.6 percentage |
Primary
Sensitivity
Sensitivity of Pocket vs VIA
Time frame: Baseline
Population: Participants with biopsy results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pocket Colposcope | Sensitivity | 26.3 percent |
| Standard of Care (VIA) | Sensitivity | 25.0 percent |
Primary
Specificity
Specificity of Pocket vs VIA
Time frame: Baseline
Population: Participants with biopsy results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pocket Colposcope | Specificity | 88.9 percent |
| Standard of Care (VIA) | Specificity | 84.0 percent |
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?
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pocket Colposcope | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | None | 0.0 percent of participants |
| Pocket Colposcope | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | Somewhat | 28.4 percent of participants |
| Pocket Colposcope | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | Very much | 68.4 percent of participants |
| Pocket Colposcope | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | A little | 3.2 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | Very much | 69.0 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | None | 0.0 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | A little | 2.5 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Expressed Confidence in Their Provider's Assessment | Somewhat | 28.4 percent of participants |
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?
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pocket Colposcope | Percent of Participants Who Reported Experiencing Pain During Their Exam | None | 21.6 percent of participants |
| Pocket Colposcope | Percent of Participants Who Reported Experiencing Pain During Their Exam | A little | 73.2 percent of participants |
| Pocket Colposcope | Percent of Participants Who Reported Experiencing Pain During Their Exam | Somewhat | 5.3 percent of participants |
| Pocket Colposcope | Percent of Participants Who Reported Experiencing Pain During Their Exam | Very much | 0 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Reported Experiencing Pain During Their Exam | Very much | 1.0 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Reported Experiencing Pain During Their Exam | None | 21.8 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Reported Experiencing Pain During Their Exam | Somewhat | 3.0 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Reported Experiencing Pain During Their Exam | A little | 74.1 percent of participants |
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.
Time frame: baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pocket Colposcope | Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire | Pre-exam | 21.6 percent of participants |
| Pocket Colposcope | Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire | Post-exam | 0.5 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire | Pre-exam | 21.8 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire | Post-exam | 0.5 percent of participants |
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?
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pocket Colposcope | Percent of Participants Who Would Recommend the Exam to a Friend | Not likely at all | 0.0 percent of participants |
| Pocket Colposcope | Percent of Participants Who Would Recommend the Exam to a Friend | Likely | 22.6 percent of participants |
| Pocket Colposcope | Percent of Participants Who Would Recommend the Exam to a Friend | Not likely | 1.1 percent of participants |
| Pocket Colposcope | Percent of Participants Who Would Recommend the Exam to a Friend | Very likely | 76.3 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Would Recommend the Exam to a Friend | Not likely | 0.0 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Would Recommend the Exam to a Friend | Not likely at all | 0.5 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Would Recommend the Exam to a Friend | Very likely | 80.7 percent of participants |
| Standard of Care (VIA) | Percent of Participants Who Would Recommend the Exam to a Friend | Likely | 18.8 percent of participants |
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?'.
Time frame: baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pocket Colposcope | Percent of Providers Who Reported Experiencing no Challenges During the Exam | 96.3 percent |
| Standard of Care (VIA) | Percent of Providers Who Reported Experiencing no Challenges During the Exam | 97.0 percent |