NCT06326294 Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
| NCT ID | NCT06326294 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Saúde, Mozambique |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,844 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,844 participants in total. It began in 2024-04-17 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Edna Viegas, MD, PhD
PRINCIPAL INVESTIGATOR
Instituto Nacional de Saúde, Mozambique
Frequently Asked Questions
Who can join the NCT06326294 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 49 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06326294 currently recruiting?
Yes, NCT06326294 is actively recruiting participants. Contact the research team at edna.viegas@ins.gov.mz for enrollment information.
Where is the NCT06326294 trial being conducted?
This trial is being conducted at Maputo, Mozambique.
Who is sponsoring the NCT06326294 clinical trial?
NCT06326294 is sponsored by Instituto Nacional de Saúde, Mozambique. The principal investigator is Edna Viegas, MD, PhD at Instituto Nacional de Saúde, Mozambique. The trial plans to enroll 4,844 participants.
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