Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
Recruiting · NCT06326294 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto Nacional de Saúde, Mozambique
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- ages 25-49 years;
- confirmed HIV infection;
- physically and mentally willing and able to participate in the study, and provide informed consent.
Exclusion criteria
- currently pregnant or \<6 weeks post-partum;
- had a hysterectomy and no longer have a cervix;
- a history of cervical cancer or treatment for cervical abnormalities; and
- any medical, psychiatric, or other condition that would interfere with protocol adherence, assessment of safety, and/or ability/competence to provide informed consent.
Where it is running
1 location listed.
- INSMozambique - Maputo, Mozambique