Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
This trial is active, not recruiting.
|Condition||cervical intraepithelial neoplasia|
|Treatments||loop electrosurgical excision procedure (leep), cryotherapy|
|Sponsor||University of Washington|
|Collaborator||University of Nairobi|
|Start date||June 2011|
|End date||November 2016|
|Trial size||400 participants|
|Trial identifier||NCT01298596, 35995-J, KE.09.0238|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
recurrence of cervical intraepithelial neoplasia among HIV-positive women
time frame: 2 years
Shedding of HIV-1 from the cervix between HIV-positive women
time frame: 3 weeks
Female participants at least 18 years old.
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.
|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|
|Principal investigator||Michael Chung, MD|
|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.|
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