Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: HIV Seropositivity; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      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
    

Detailed 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.):

        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.

      SECONDARY AIMS:

      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
      seropositive women.
    

Intervention name(s): Cryotherapy; LEEP
Intervention type(s): Procedure; Procedure
Intervention description(s): This is involves freezing the lesions with a cryo gun using Nitrous Oxide for 3 minutes-- wait 5 minutes and then refreezing for 3 more minutes. This procedure uses the Wallach cryogun; The cervix is anaesthetized with lidocaine and then a electric loop is applied to the cervical lesion which is cut with one pass. The LEEP machine used is the automatic Finesse Machine.
Other intervention name(s): This is a study using Freezing with a cryogun; Loop Electric Excision Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Dysplasia; Cin 2; Cin 3; HIV positive women; South Africa