Comparing two treatments for cervical precancer in women living with HIV in Mozambique
Compares thermal ablation and LEEP treatments for cervical precancer in women with HIV.
Plain-language title generated from the registry record
Registry title: Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
Key facts
- Where
- Maputo, MozambiqueSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 49 years old?
Source: NCT06326294, who can take part
Where in Mozambique
- INSMozambiqueMaputo, MozambiqueTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto Nacional de Saúde, Mozambique
- Trial code
- NCT06326294
- Record updated
- 22 May 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: ages 25-49 years; confirmed HIV infection; physically and mentally willing and able to participate in the study, and provide informed consent.
Exclusion: 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; currently pregnant or <6 weeks post-partum; had a hysterectomy and no longer have a cervix.