Brief Title
Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
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
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
Interventional
Primary Outcome
Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women
Secondary Outcome
Shedding of HIV-1 From the Cervix Between HIV-positive Women
Condition
Cervical Intraepithelial Neoplasia
Intervention
Loop Electrosurgical Excision Procedure (LEEP)
Study Arms / Comparison Groups
Cryotherapy
Description: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
400
Start Date
June 2011
Completion Date
January 2017
Primary Completion Date
October 2016
Eligibility 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michael Chung, MD, ,
Location Countries
Kenya
Location Countries
Kenya
Administrative Informations
NCT ID
NCT01298596
Organization ID
35995-J
Secondary IDs
KE.09.0238
Responsible Party
Principal Investigator
Study Sponsor
University of Washington
Collaborators
University of Nairobi
Study Sponsor
Michael Chung, MD, Principal Investigator, University of Washington
Verification Date
October 2019