|

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

RECRUITINGN/ASponsored by Instituto Nacional de Saúde, Mozambique
Actively Recruiting
PhaseN/A
SponsorInstituto Nacional de Saúde, Mozambique
Started2024-04-17
Est. completion2027-09
Eligibility
Age25 Years – 49 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 25 Years – 49 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions4

CIN 2/3CancerHIV InfectionsHPV Infection

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.