Trial Information

Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women

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 2 months of follow-up.