Actively Recruiting
Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
Led by Instituto Nacional de Saúde, Mozambique · Updated on 2024-05-22
4844
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
I
Instituto Nacional de Saúde, Mozambique
Lead Sponsor
M
M.D. Anderson Cancer Center
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 25 to 49 years
- Confirmed HIV infection
- Physically and mentally able and willing to participate and provide informed consent
You will not qualify if you...
- Currently pregnant or less than 6 weeks postpartum
- History of hysterectomy and no longer have a cervix
- History of cervical cancer or treatment for cervical abnormalities
- Any medical, psychiatric, or other condition that would interfere with study adherence, safety assessment, or ability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
INSMozambique
Maputo, Mozambique
Actively Recruiting
Research Team
E
Edna Viegas, MD, PhD
CONTACT
E
Edna Nhacule, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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