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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
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cervical Intraepithelial Neoplasia Procedure: Loop Electrosurgical Excision Procedure (LEEP) Procedure: Cryotherapy

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 2011
Primary Completion Date : October 2016
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cryotherapy
Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
Procedure: Cryotherapy
Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
Experimental: Loop Electrosurgical Excision Procedure
Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 over 6 weeks of follow-up


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298596


Locations
Kenya
Coptic Hospital
Nairobi, Kenya, 21570-00505
Sponsors and Collaborators
University of Washington
University of Nairobi
International Agency for Research on Cancer
Investigators
Principal Investigator: Michael Chung, MD University of Washington
More Information

Responsible Party: Michael Chung, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01298596     History of Changes
Other Study ID Numbers: 35995-J
KE.09.0238 ( Other Identifier: Kenya Ethical Review Committee )
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type