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

NCT ID: NCT02250716

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-08-31

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

Conditions

Cervical Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up

Group Type: EXPERIMENTAL

cryotherapy

Intervention Type: PROCEDURE

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

Arm 2

12 month cytology and histology follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cryotherapy

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: lead

Responsible Party

Cynthia S Firnhaber

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia S Firnhaber, MD

Role: PRINCIPAL_INVESTIGATOR

University of Witwatersrand, South Africa

Locations

University of Witwatersrand/Helen Joseph Hospital

Johannesburg, , South Africa

Countries

South Africa

Other Identifiers

CIN1

Identifier Type: -

Identifier Source: org_study_id