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

University of Washington

Status: Completed

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Procedure: Cryotherapy; Procedure: Loop Electrosurgical Excision Procedure (LEEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01298596

35995-J

KE.09.0238 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Cryotherapy

Experimental group

Description:

Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix

Treatment:

Procedure: Cryotherapy

Loop Electrosurgical Excision Procedure

Experimental group

Description:

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

Treatment:

Procedure: Loop Electrosurgical Excision Procedure (LEEP)