Comparing two treatments for cervical cancer risk reduction in women living with HIV in Mozambique
Official title: 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
Run by Instituto Nacional de Saúde, Mozambique · NCT06326294 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 49 Years |
| Sex | Women only |
| Enrollment | 4844 (estimated) |
| Sponsor | Instituto Nacional de Saúde, Mozambique Government |
| Locations | 1 site (Maputo) |
| Status | Recruiting |
| Started | April 17, 2024 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | May 22, 2024 |
| Trial ID | NCT06326294 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 25-49 years who are confirmed to be HIV positive.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with similar treatment comparisons, but this specific approach in the context of WLWH in Mozambique is novel.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.