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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01298596 |
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Date of registration:
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16/02/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
PHE-LEEP |
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Scientific title:
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Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01298596 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Michael Chung, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV positive receiving care at the Coptic Hope Center
- Not pregnant by clinical examination or history
- Have an intact cervix
- Have not received prior cervical treatment
- Do not have a history of a bleeding disorder
- Are above 18 years of age
Exclusion Criteria:
- HIV-negative
- Male
- Below 18 years of age
- Pregnant by clinical examination or history
- Post-hysterectomy
- Post-cervical cancer treatment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical Intraepithelial Neoplasia
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Intervention(s)
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Procedure: Loop Electrosurgical Excision Procedure (LEEP)
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Procedure: Cryotherapy
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Primary Outcome(s)
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Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women
[Time Frame: 2 years]
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Secondary Outcome(s)
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Shedding of HIV-1 From the Cervix Between HIV-positive Women
[Time Frame: 3 weeks]
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Secondary ID(s)
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35995-J
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KE.09.0238
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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