Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women (VICAR2)

University of Witwatersrand

Status

Completed

Conditions

Cervical Intraepithelial Neoplasia

Treatments

Procedure: Cryotherapy

Procedure: LEEP

Study type

Interventional

Funder types

Other

Identifiers

NCT01723956

ZA.09.0265

Details and patient eligibility

About

To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.

Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV positive women in South Africa

Full description

Cervical cancer is the most common cancer in HIV positive women. This is due to immunosuppression and lack of organized and effective screening and treatment programs in Africa. Other screening and treatment modalities need to be evaluated in resource limited countries as there is not capacity in most of these countries to implement a cytology/histology based program. The treatment modality of cryotherapy is easy to train and perform and can be done by a nurse. LEEP requires significant training usually doctors and skills in administering local anaesthetic. This study compares the two modalities of cryotherapy vs LEEP in a randomized controlled study in HIV positive women in South Africa.

A. PRIMARY AIMS (S.A.):

To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women.

SECONDARY AIMS:

To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
To evaluate the relationship between HIV status, demographics, HPV, and sexual behavior with the clearance of cervical disease at the ectocervical and endocervical margins in HIV seropositive women.

Enrollment

166 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women 18-65 years of age
Not menstruating (if menstruating, the patient can be screened at another date)
Able to sign consent
Able to follow the study protocol
HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1)
Participant with histology-proven CIN 2 or 3 disease

Exclusion criteria

Pregnant
Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management)
Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy)
Previous hysterectomy with removal of the cervix
Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk
Cervical dysplastic lesions that are not appropriate for cryotherapy, defined as the following:
1. Lesion is greater than ≥75% cervix
2. Lesion entering into the cervical canal and the complete lesion cannot be visualized
3. Presence of abnormal vasculature
4. Lesion bigger that the cryotherapy probe