Cervical precancer, human papillomavirus.
Conditions
Interventions
Large Loop Excision of the Transformation Zone LLETZ
Thermal Ablation
Sponsors
Stellenbosch University Gynaecological Oncology Research Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Female gender Living with HIV Age 30 years and above; younger than 60 years Negative pregnancy test Never treated for precancer/cancer Two episodes of Low-grade squamous intraepithelial lesions (LSIL) at least six months apart on cytology or one High-grade squamous intraepithelial lesion (HSIL) Receipt of ART for at least 30 days prior to randomization. Informed consent accepted and signed
Exclusion criteria
Exclusion criteria: Previous hysterectomy/Current pregnancy HIV negative Age younger than 30 years or older than 60 years Hesitant or unable to undergo screening and treatment if indicated Current or previous treatment for gynaecological cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the treatment failure of TA vs. excision based on cervical cytology, histology and HPV status at 26-week intervals up to two years after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess patient experiences with side effects and safety when treated with TA versus excision. ;To evaluate the anatomy of the cervix for structural changes that may impact reproductive outcomes before and after treatment using colposcopy with mobile imaging. | — |
Countries
South Africa
Contacts
Public ContactRobyn Anne Adams
Research Coordinator
Outcome results
None listed