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A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women
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.
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
Age
18 - 65 years
Sex
FEMALE
Healthy Volunteers
No
University of Witwatersrand/Helen Joseph Hospital
Johannesburg, South Africa
Start Date
October 1, 2012
Primary Completion Date
August 1, 2015
Completion Date
August 1, 2016
Last Updated
December 3, 2015
480
ESTIMATED participants
cryotherapy
PROCEDURE
Lead Sponsor
University of Witwatersrand, South Africa
NCT05606133
NCT05132114
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06598176