A Randomized Clinical Trial to Assess the Effectiveness of Thermal Ablation Versus Loop Electrosurgical Excision Procedure for Cervical Cancer Risk Reduction in Women Living With Human Immunodeficiency Virus in Mozambique

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2/3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 49
Healthy Volunteers: f
View:

• ages 25-49 years;

• confirmed HIV infection;

• physically and mentally willing and able to participate in the study, and provide informed consent.

Locations
Other Locations
Mozambique
INSMozambique
RECRUITING
Maputo
Contact Information
Primary
Edna Viegas, MD, PhD
edna.viegas@ins.gov.mz
+258823060500
Backup
Edna Nhacule, MD
edna.nhacule@ins.gov.mz
845210269
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2027-12
Participants
Target number of participants: 4844
Treatments
Other: Thermo ablation treatment
Participants allocated in this group will be treated with thermo ablation. Before TA, perform biopsies of any acetowhite lesions by colposcopy and/or positive by AVE and an endocervical curettage (ECC); In women who do not have any lesions noted by colposcopy or AVE, one random cervical biopsy at the squamocolumnar junction and an endocervical curettage (ECC) will be obtained.~TA is performed during the same exam (immediately following biopsies/ECC)TA will be done according to the manufacturer's instructions and specifications.
Other: LEEP treatment
Participants allocated in this group will be treated with LEEP. LEEP will be done according to standard procedure. No biopsies are taken, only LEEP is performed, unless clinically indicated.
Related Therapeutic Areas
Sponsors
Leads: Instituto Nacional de Saúde, Mozambique
Collaborators: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov