Clinical Trial: Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-posit

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 Summary:

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.

Sponsor: University of Washington

Current Primary Outcome: recurrence of cervical intraepithelial neoplasia among HIV-positive women [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Shedding of HIV-1 from the cervix between HIV-positive women [ Time Frame: 3 weeks ]

Original Secondary Outcome: Shedding of HIV-1 from the cervix between HIV-positive women [ Time Frame: 6 weeks ]

Information By: University of Washington

Dates:
Date Received: February 16, 2011
Date Started: June 2011
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017