Cervical Dysplasia
Conditions
Keywords
CIN1, HIV seropositive women, Cryotherapy
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
Interventions
PROCEDUREcryotherapy
cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)
Sponsors
University of Witwatersrand, South Africa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regresson of CIN1 to a normal biopsy | 12 month | Treatment failure is the progression of CIN1 to CIN2 |
Countries
South Africa
Outcome results
None listed