Clinical trial NCT02338141: Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women
Official title: Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Human Papillomavirus
Human Immunodeficiency Virus
Keywords: cervical cancer
colposcopy
human papillomavirus
human immunodeficiency virus
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 132
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
timeFrame: Point-of-care (at time of examination, approximately one hour)
measure: Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method
timeFrame: Point-of-care (at time of examination, approximately one hour)
measure: Rate of concordance between vascular patterns indicative of high-grade squamous intraepithelial lesions and biopsy by visualization method
timeFrame: Point-of-care (at time of examination, approximately one hour)
Secondary outcomes:
measure: Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity
timeFrame: Point-of-care (at time of examination, approximately one hour)
measure: Prevalence of HPV genotypes by HIV status
timeFrame: Point-of-care (at time of examination, approximately one hour)
Other outcomes:
Locations:
city: Port-au-Prince
country: Haiti
facility: Blanchard Clinic
Study officials:
affiliation: Duke Health
name: David K Walmer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: