|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02338141 |
|
Date of registration:
|
30/12/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women
|
|
Scientific title:
|
Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
132 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02338141 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Participant).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Haiti
| | | | | | | |
|
Contacts
|
|
Name:
|
David K Walmer, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Duke University Health System |
| | |
|
Key inclusion & exclusion 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
Age minimum:
25 Years
Age maximum:
60 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Human Immunodeficiency Virus
|
|
Cervical Cancer
|
|
Human Papillomavirus
|
|
Intervention(s)
|
|
Device: Portable colposcopy (Cerviscope)
|
|
Device: Conventional colposcopy (Wallach Zoomscope)
|
|
Primary Outcome(s)
|
|
Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method
[Time Frame: 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
[Time Frame: Point-of-care (at time of examination, approximately one hour)]
|
|
Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
[Time Frame: Point-of-care (at time of examination, approximately one hour)]
|
|
Secondary Outcome(s)
|
|
Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity
[Time Frame: Point-of-care (at time of examination, approximately one hour)]
|
|
Prevalence of HPV genotypes by HIV status
[Time Frame: Point-of-care (at time of examination, approximately one hour)]
|
|
Secondary ID(s)
|
|
Pro00055627
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|