Brief Title
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women
Official Title
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women
Brief 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
Study Type
Interventional
Primary Outcome
Regresson of CIN1 to a normal biopsy
Condition
Cervical Dysplasia
Intervention
cryotherapy
Study Arms / Comparison Groups
Arm 1
Description: Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
480
Start Date
October 2012
Completion Date
August 2016
Primary Completion Date
August 2015
Eligibility Criteria
Inclusion Criteria:
- HIV -infected women whose biopsy proves CIN1 and who consent to study participants and
procedures
- CIN1 with no visible lesion
- The entire ectocervical lesion should cover less than 75% of the cervix and not more
than 2 - 3mm into the endocervical canal
Exclusion Criteria:
- Pregnant women
- Known and previous treatment for HSIL by any method (Cryotherapy, LEEP or cone biopsy)
- Women who are menstruating or who have active pelvic inflammatory disease will be
deferred from the study until the infection is cleared or the menstrual cycle has
ended; the patient may then participate in the study.
- Unsatisfactory colposcopic examination defined as inability to see the extent of the
lesion in the endocervical canal and lesions deemed ineligible for cryotherapy by an
OB/GYN specialist.
- Previous hysterectomy with removal of the cervix
Gender
Female
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Cynthia S Firnhaber, MD, ,
Location Countries
South Africa
Location Countries
South Africa
Administrative Informations
NCT ID
NCT02250716
Organization ID
CIN1
Responsible Party
Principal Investigator
Study Sponsor
University of Witwatersrand, South Africa
Study Sponsor
Cynthia S Firnhaber, MD, Principal Investigator, University of Witwatersrand, South Africa
Verification Date
December 2015