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Note: This record shows only the 20 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.
Last refreshed on: 2 June 2014
Main ID:  NCT01298596
Date of registration: 16/02/2011
Primary sponsor: University of Washington
Public title: Cryotherapy vs. LEEP to Treat CIN2/3 Among HIV-positive Women PHE-LEEP
Scientific title: Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women
Date of first enrolment: June 2011
Target sample size: 400
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Cervical Intraepithelial Neoplasia
Procedure: Cryotherapy
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Primary Outcome(s)
recurrence of cervical intraepithelial neoplasia among HIV-positive women [Time Frame: 2 years]
Secondary Outcome(s)
Shedding of HIV-1 from the cervix between HIV-positive women [Time Frame: 3 weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
International Agency for Research on Cancer
University of Nairobi
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