Clinical trial NCT02250716: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Dysplasia
Keywords: CIN1
HIV seropositive women
Cryotherapy
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Regresson of CIN1 to a normal biopsy
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: University of Witwatersrand/Helen Joseph Hospital
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Cynthia S Firnhaber, MD
role: PRINCIPAL_INVESTIGATOR
References: