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Cryotherapy vs. LEEP to Treat CIN2/3 Among HIV-positive Women (PHE-LEEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Collaborators:
University of Nairobi
International Agency for Research on Cancer
Information provided by (Responsible Party):
Michael Chung, University of Washington
ClinicalTrials.gov Identifier:
NCT01298596
First received: February 16, 2011
Last updated: May 20, 2014
Last verified: May 2014

February 16, 2011
May 20, 2014
June 2011
November 2016   (final data collection date for primary outcome measure)
recurrence of cervical intraepithelial neoplasia among HIV-positive women [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up
Same as current
Complete list of historical versions of study NCT01298596 on ClinicalTrials.gov Archive Site
Shedding of HIV-1 from the cervix between HIV-positive women [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 6 weeks of follow-up
Shedding of HIV-1 from the cervix between HIV-positive women [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 6 weeks of follow-up
Not Provided
Not Provided
 
Cryotherapy vs. LEEP to Treat CIN2/3 Among HIV-positive Women
Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
  • Procedure: Loop Electrosurgical Excision Procedure (LEEP)
    LEEP procedure uses a heated wire to scoop out disease from the cervix
    Other Name: LEEP
  • Procedure: Cryotherapy
    Cryotherapy procedure which will freeze and remove the diseased part of the cervix
  • Experimental: Cryotherapy
    Cryotherapy procedure which will freeze and remove the diseased part of the cervix
    Intervention: Procedure: Cryotherapy
  • Experimental: Loop Electrosurgical Excision Procedure (LEEP)
    LEEP procedure uses a heated wire to scoop out disease from the cervix
    Intervention: Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
November 2016
November 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Kenya
 
NCT01298596
35995-A, KE.09.0238
Yes
Michael Chung, University of Washington
University of Washington
  • University of Nairobi
  • International Agency for Research on Cancer
Principal Investigator: Michael Chung, MD University of Washington
University of Washington
May 2014

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