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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
| Universidad Peruana Cayetano Heredia | 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. The objective is to provide colposcopy capability to rural communities in Peru potentially using Telehealth. Approximately 10,000 women will receive self HPV test kit for community health workers. Of these participants, approximately 1,000 HPV+ participants will be invited to participate in this pocket colposcopy study. Approximately 500 of these participants may require treatment using thermocoagulation.
The goal is to demonstrate that the combination of self-sampling, the Pocket colposcope and the thermocoagulator will yield a high proportion of HPV positive women who complete treatment and follow-up care. The bulk of this trial will occur over a two-year period in Peru. Duke will provide the Pocket colposcope and the Calla application to run the device only. Dr. Garcia will recruit and train community women for the distribution of self-collection HPV test kits, identify and partner with 10 to 12 health centers in the Andean region of Peru, conduct baseline data collection in each health center, procure necessary equipment and technology, and conduct training for HPV testing, Pocket colposcopy, and thermocoagulation. Within 18 months trained community women will distribute 10,000 HPV tests to women within the region. The investigators anticipate that 10% of the women screened will be HPV positive and they will be recruited for our trial. As part of the study the participants will be followed to determine if the participants attend a health center, receive Pocket colposcopy, and if needed whether the participants are treated with the thermocoagulator device. All women will be appointed to return to the health center for a follow-up evaluation six months post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV+ Pap smear | Experimental | Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colposcopy using pocket colpscope and thermocoagulator | Device | If HPV+, visualization with pocket colposcope and treatment with thermocoagulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of HPV Positive Women Examined | Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope | up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment | 6 months after initial visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nimmi Ramanujam, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Peruana Cayetano Heredia | Lima | Peru |
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3734 HPV tests were administered for screening purposes to participate in this study. Of these, 534 women were HPV+. 503 of those were consented to the study
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| ID | Title | Description |
|---|---|---|
| FG000 | HPV+ Pap Smear | Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. Colposcopy using pocket colpscope and thermocoagulator: If HPV+, visualization with pocket colposcope and treatment with thermocoagulator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HPV+ Pap Smear | Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. Colposcopy using pocket colpscope and thermocoagulator: If HPV+, visualization with pocket colposcope and treatment with thermocoagulator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Number of HPV Positive Women Examined | Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope | Posted | Count of Participants | Participants | up to approximately 1 year |
|
|
Approximately 6 months
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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 | HPV+ Pap Smear | Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. Colposcopy using pocket colpscope and thermocoagulator: If HPV+, visualization with pocket colposcope and treatment with thermocoagulator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nimmi Ramanujam, PhD | Duke University | 9196605307 | nimmi@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 | Oct 10, 2023 | Apr 11, 2024 | Prot_SAP_000.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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| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment | Posted | Count of Participants | Participants | 6 months after initial visit |
|
|
|
| 0 |
| 503 |
| 0 |
| 503 |
| 0 |
| 503 |
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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 |