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

Cervical Dysplasia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02250716
Study type Interventional
Source University of Witwatersrand, South Africa
Contact
Status Active, not recruiting
Phase N/A
Start date October 2012
Completion date August 2016
View Details
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