Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.

Detailed Description
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This research is a randomized, prospective trial designed to evaluate the value of magnification in making a diagnosis of high grade intraepithelial lesions of the cervix. The overall goal is to evaluate a cervical cancer screening protocol that provides the highest level of care possible for low-resource communities and hard-to-reach areas. Currently, a national cervical cancer screening and diagnosis program does not exist within Haiti. All women meeting inclusion criteria will be randomized to portable (8x magnification with the Cerviscope) or conventional (25x magnification) colposcopy. After application of acetic acid to the cervix, the physician will record naked eye observations of the cervix by: 1) recording the location of all white lesions; 2) describing the vascular pattern; and 3) stating his/her clinical impression of a diagnosis. The physician will then follow-up with use of either the portable or the conventional colposcope to: 1) record the location of all white lesions; 2) describe the vascular pattern; and 3) state a clinical impression of diagnosis. Women will have biopsies in all four quadrants of the cervix even if no cervical lesions are seen to evaluate the accuracy of the visualization techniques against the gold standard of biopsy pathologic results. Treatment options will be dictated by biopsy results. Biopsy material will also be evaluated for specific HPV genotype using lab-based measures. Results of these genotypes will be compared between women with high-grade disease vs. low-grade disease and in the subset of women with HIV compared to the HIV-negative population.

Official Title
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Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti

Conditions
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Cervical Cancer, Human Papillomavirus, Human Immunodeficiency Virus

Intervention / Treatment
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* Device: Portable colposcopy (Cerviscope)
* Device: Conventional colposcopy (Wallach Zoomscope)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 25-60 years old Pre-tested as positive for human papillomavirus (HPV) Exclusion Criteria: Pre-tested as negative for human papillomavirus (HPV) Pregnant at time of enrollment Prior hysterectomy < 25 or > 60 years old Male

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portable colposcopy<br>Diagnostic evaluation with 8x magnification portable colposcopy after visual inspection with acetic acid | Device: Portable colposcopy (Cerviscope)<br>* HPV-positive women will be evaluated with portable colposcopy (with a novel portable colposcope known as the Cerviscope) after visual inspection with acetic acid and prior to biopsy in the experimental group.<br>* Other names: Cerviscope;|
| Active Comparator: Conventional colposcopy<br>Diagnostic evaluation with standard 25x magnification conventional colposcopy after visual inspection with acetic acid | Device: Conventional colposcopy (Wallach Zoomscope)<br>* HPV-positive women will be evaluated with conventional colposcopy (with the Wallach Zoomscope) after visual inspection with acetic acid and prior to biopsy per usual standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method | The number of correct diagnoses of HSIL by eventual pathologic diagnosis will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings). | Point-of-care (at time of examination, approximately one hour) | 
| Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method | Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Rates of detection of these abnormal vascular patterns will be compared between 8x magnification (Cerviscope) and 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and between both and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings). | Point-of-care (at time of examination, approximately one hour) | 
| Rate of concordance between vascular patterns indicative of high-grade squamous intraepithelial lesions and biopsy by visualization method | Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Concordance between these visualized vascular patterns and eventual pathologic diagnosis from biopsy will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings). | Point-of-care (at time of examination, approximately one hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity | HPV genotypes will be performed for patients and reported as percentages isolated for the differing lesion grades of HSIL vs. non-HSIL cervical lesions based on genotype results and correlation with biopsy results. | Point-of-care (at time of examination, approximately one hour) | 
| Prevalence of HPV genotypes by HIV status | HPV genotypes will be performed for patients and reported as percentages isolated for HIV positive and negative women based on genotype results after HIV status is determined. This will be further reported by HIV status in women with different lesion severities. | Point-of-care (at time of examination, approximately one hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, colposcopy, human papillomavirus, human immunodeficiency virus