Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
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 (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix
loop electrosurgical excision procedure (leep) LEEP
LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Primary Outcomes

Measure
recurrence of cervical intraepithelial neoplasia among HIV-positive women
time frame: 2 years

Secondary Outcomes

Measure
Shedding of HIV-1 from the cervix between HIV-positive women
time frame: 3 weeks

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Washington.