Clinical trial · Interventional
Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
| HIV Infections | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LOOP ELECTROSURGICAL EXCISION PROCEDURE | Procedure | — | UNRESOLVED |
| Thermal ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Thermo ablation treatment
- description
- Participants allocated in this group will be treated with thermo ablation. Before TA, perform biopsies of any acetowhite lesions by colposcopy and/or positive by AVE and an endocervical curettage (ECC); In women who do not have any lesions noted by colposcopy or AVE, one random cervical biopsy at the squamocolumnar junction and an endocervical curettage (ECC) will be obtained. TA is performed during the same exam (immediately following biopsies/ECC)TA will be done according to the manufacturer's instructions and specifications.
- interventionNames
- Device: Thermal ablation
- type
- OTHER
- label
- LEEP treatment
- description
- Participants allocated in this group will be treated with LEEP. LEEP will be done according to standard procedure. No biopsies are taken, only LEEP is performed, unless clinically indicated.
- interventionNames
- Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFallah PN, Salcedo MP, Nhacule E, Utui Y, Massinga MM, Osman NB, Tivir GG, Carrilho C, Monteiro E, Rangeiro R, Neves A, Changule D, Mariano A, Machaze A, Castiano CE, Baker E, Jeronimo J, Chiao EY, Munsell MF, Varon ML, Milan J, Thomas JP, Richards-Kortum R, Lorenzoni C, Omar Viegas EN, Castle PE, Schmeler KM. 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 HIV in Mozambique. Int J Gynecol Cancer. 2026 Jan;36(1):101905. doi: 10.1016/j.ijgc.2025.101905. Epub 2025 Apr 26. PMID 40399211