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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02250716
• Other study ID #: CIN1
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2014
• Last updated: December 1, 2015
• Start date: October 2012
• Est. completion date: August 2016

Study information

• Verified date: December 2015
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• HIV Seropositivity
• Uterine Cervical Dysplasia

Intervention

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

Locations

Country	Name	City	State
South Africa	University of Witwatersrand/Helen Joseph Hospital	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regresson of CIN1 to a normal biopsy	Treatment failure is the progression of CIN1 to CIN2	12 month	No