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

Sponsor

University of Witwatersrand, South Africa (Other)

Overall Status

Unknown status

CT.gov ID

NCT02250716

Collaborator

(none)

480

Enrollment

Location

Arms

Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Dysplasia	Procedure: cryotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up	Procedure: cryotherapy cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)
No Intervention: Arm 2 12 month cytology and histology follow-up

Arm

Intervention/Treatment

Experimental: Arm 1

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

Procedure: cryotherapy

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

No Intervention: Arm 2

12 month cytology and histology follow-up

Outcome Measures

Primary Outcome Measures

Regresson of CIN1 to a normal biopsy [12 month]
Treatment failure is the progression of CIN1 to CIN2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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