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

Not Applicable

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Procedure: Loop Electrosurgical Excision Procedure (LEEP); Procedure: Cryotherapy

• Registration Number: NCT01298596
• Lead Sponsor: University of Washington

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 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.

Study Timeline

• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Study Start: 2011-06
• Primary Completion: 2016-10
• Study Completion: 2017-01
• Results First Submitted: 2019-09-23
• Results First Submitted QC: 2019-09-23
• Status Verified: 2019-10
• Results First Posted: 2019-10-18
• Last Update Submitted: 2019-10-19
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

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Exclusion Criteria

• HIV-negative
• Male
• Below 18 years of age
• Pregnant by clinical examination or history
• Post-hysterectomy
• Post-cervical cancer treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loop Electrosurgical Excision Procedure	Loop Electrosurgical Excision Procedure (LEEP)	Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix
Cryotherapy	Cryotherapy	Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix

Primary Outcome Measures

Name	Time	Method
Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women	2 years	Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up

Secondary Outcome Measures

Name	Time	Method
Shedding of HIV-1 From the Cervix Between HIV-positive Women	3 weeks	Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP between baseline and weeks 1, 2, and 3 of follow-up

Trial Locations

Locations (1)

Coptic Hospital; 🇰🇪 Nairobi, Kenya