NCT02250716

A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women

A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Based on the high incidence of cervical cancer and high grade dysplasia and increased progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have had a colposcopic biopsy for persistent LSIL as per standard of care.

Detailed description

Women with HIV have a higher risk of cervical cancer. Screening and treatment formaly of the disease is limited die to poor access of screening programs and multiple visits. Women with HIV also have high progressions rates of disease amd my need to be treated earliers. Cryotherapy is a low option and very easy to implement especially in low resource provinces. * It is cheaper and easier to administer than Large Loop electrosurgical excision procedure (LLETZ) * No histology or transportation costs of specimens * Less invasive than LLETZ * It is nurse driven and easily learned * It decreases loss to follow-up of patients due to reduced waiting time, transportation costs, time off work and HIV stigma

Conditions

• Cervical Dysplasia

Interventions

Type	Name	Description
PROCEDURE	cryotherapy	cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2014-09-26
• Last updated: 2015-12-03

Locations

1 site across 1 country: South Africa