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Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique

NCT06326294 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4844

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Thermal ablation

Thermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the cervical transformation zone and destroy the abnormal epithelium.

PROCEDURE

LOOP ELECTROSURGICAL EXCISION PROCEDURE

Cervical tissue excision

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Instituto Nacional de Saúde, Mozambique

    lead OTHER_GOV

Principal Investigators

  • Edna Viegas, MD, PhD · Instituto Nacional de Saúde, Mozambique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Mozambique

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326294 on ClinicalTrials.gov