Comparing two treatments for cervical cancer risk reduction in women living with HIV in Mozambique
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
This study is testing two different treatments for pre-cancerous cervical lesions in women living with HIV in Mozambique to see which one works better in getting rid of high-risk HPV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4844 (estimated) |
| Ages | 25 Years to 49 Years |
| Sex | Female |
| Sponsor | Instituto Nacional de Saúde, Mozambique Government |
| Locations | 1 site (Maputo) |
| Trial ID | NCT06326294 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of thermal ablation (TA) and loop electrosurgical excision procedure (LEEP) in treating pre-cancerous cervical lesions and HPV infections in women living with HIV (WLWH) in Mozambique. It will assess the effectiveness of both treatments in eradicating high-risk HPV and managing biopsy-confirmed CIN 2/3. Additionally, the study will identify factors that contribute to treatment failure and develop a predictive tool to help tailor alternative treatments for patients at risk of failure. The findings will provide local evidence to inform health policy and improve adherence to cervical cancer prevention strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25-49 years who are confirmed to be HIV positive.
Not a fit: Patients who are currently pregnant, have had a hysterectomy, or have a history of cervical cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and accessible treatment options for cervical cancer prevention in women living with HIV.
How similar studies have performed: Other studies have shown success with similar treatment comparisons, but this specific approach in the context of WLWH in Mozambique is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maputo
- INSMozambique — Maputo, Mozambique (Recruiting)
Study contacts
- Principal investigator: Edna Viegas, MD, PhD — Instituto Nacional de Saúde, Mozambique
- Study coordinator: Edna Viegas, MD, PhD
- Email: edna.viegas@ins.gov.mz
- Phone: +258823060500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.