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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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ClinicalTrials.gov Identifier: NCT01298596
Recruitment Status : Completed
First Posted : February 17, 2011
Results First Posted : October 18, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
University of Nairobi
International Agency for Research on Cancer
Information provided by (Responsible Party):
Michael Chung, University of Washington

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 17, 2011
Results First Submitted Date  ICMJE September 23, 2019
Results First Posted Date  ICMJE October 18, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE June 2011
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women [ Time Frame: 2 years ]
Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2019)
Shedding of HIV-1 From the Cervix Between HIV-positive Women [ Time Frame: 3 weeks ]
Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP between baseline and weeks 1, 2, and 3 of follow-up
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
Shedding of HIV-1 From the Cervix Between HIV-positive Women [ Time Frame: 6 weeks ]
Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 6 weeks of follow-up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
Official Title  ICMJE Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women
Brief Summary The purpose of this study is to compare the rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 3 weeks of follow-up.
Detailed Description

The recent scale-up of antiretroviral treatment programs in resource-limited settings provides an unprecedented opportunity to implement a comprehensive cervical cancer screening and treatment program for women who, by virtue of having HIV, are at significant risk for cervical disease. Unfortunately, even if screening is offered free of charge to millions of women living with HIV, it is unclear which treatment modality for pre-cancerous cervical lesions will be most effective since HIV appears to affect outcomes of treatment by increasing the recurrence and severity of cervical disease. Cervical treatment may also increase shedding of HIV from the cervix which may put discordant couples at risk and possibly spread HIV more widely. This study proposes to randomize HIV-positive women with cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) to cryotherapy vs. loop electrosurgical excision procedure (LEEP) and measure the recurrence of cervical disease in each group over 2-years of follow-up as well as HIV shedding from the cervix for 6 weeks after treatment.

Our hypothesis is that compared to cryotherapy, LEEP is significantly more likely to prevent recurrence of cervical lesions over 2 years of follow-up and less likely to cause shedding of HIV-1 from the cervix over 3 weeks of follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Intraepithelial Neoplasia
Intervention  ICMJE
  • Procedure: Loop Electrosurgical Excision Procedure (LEEP)
    LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix
    Other Name: LEEP
  • Procedure: Cryotherapy
    Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
Study Arms  ICMJE
  • Experimental: Cryotherapy
    Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
    Intervention: Procedure: Cryotherapy
  • Experimental: Loop Electrosurgical Excision Procedure
    Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix
    Intervention: Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2011)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01298596
Other Study ID Numbers  ICMJE 35995-J
KE.09.0238 ( Other Identifier: Kenya Ethical Review Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Chung, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • University of Nairobi
  • International Agency for Research on Cancer
Investigators  ICMJE
Principal Investigator: Michael Chung, MD University of Washington
PRS Account University of Washington
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP