Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
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.):
1. 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.
2. 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.
3. To compare the safety of cryotherapy versus LLETZ in HIV seropositive women.
1. To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior
in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
3. To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
4. 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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare efficacy of cryotherapy and LEEP
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.
South Africa USAID: Public Health Evaluation Committee of Office of Global Aids Coordinator