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. 2025 Apr 26:101905.
doi: 10.1016/j.ijgc.2025.101905. Online ahead of print.

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

Parisa N Fallah  1 , Mila P Salcedo  1 , Edna Nhacule  2 , Yolanda Utui  2 , Marcia M Massinga  2 , Nafissa B Osman  3 , Guilhermina G Tivir  2 , Carla Carrilho  3 , Eliane Monteiro  4 , Ricardina Rangeiro  4 , Andrea Neves  5 , Dercia Changule  4 , Arlete Mariano  6 , Alberto Machaze  2 , Celso E Castiano  2 , Ellen Baker  1 , Jose Jeronimo  7 , Elizabeth Y Chiao  8 , Mark F Munsell  9 , Melissa L Varon  1 , Jessica Milan  1 , Joseph P Thomas  10 , Rebecca Richards-Kortum  11 , Cesaltina Lorenzoni  12 , Edna N Omar Viegas  2 , Philip E Castle  7 , Kathleen M Schmeler  13
Affiliations

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

Parisa N Fallah et al. Int J Gynecol Cancer. .

Abstract

Background: Cervical cancer remains a leading cause of death in low- and middle-income countries. Women living with human immunodeficiency virus (HIV) carry a 6-fold higher risk of cervical cancer than the general population. The effectiveness of thermal ablation versus loop electrosurgical excision procedure (LEEP) in women living with HIV is uncertain, prompting this study.

Primary objective: To compare the effectiveness of thermal ablation versus LEEP for the management of abnormal cervical cancer screening results in women living with HIV.

Study hypothesis: Thermal ablation is non-inferior to LEEP for treatment of cervical intra-epithelial neoplasia (CIN) 2/3 and high-risk human papillomavirus (hrHPV) infection in women living with HIV.

Trial design: This is a prospective randomized clinical trial. Participants undergo screening with primary hrHPV testing. Those with positive hrHPV results undergo visual inspection with acetic acid and a review of genotyping results to determine eligibility for treatment. Those who are hrHPV-positive and positive by visual assessment with acetic acid, or human papillomavirus16/18 positive regardless of visual assessment with acetic acid result, are randomized to thermal ablation or LEEP. Participants undergo follow-up at 4 to 8 weeks, 6 months, and 12 months post-procedure.

Major inclusion/exclusion criteria: Participants include 25 to 49-year-old women living with HIV in Mozambique. Exclusion criteria include pregnancy, previous total hysterectomy, history of cervical cancer or prior treatment for CIN, or any condition that would preclude adherence to the study protocol.

Primary endpoints: Persistent or recurrent CIN 2/3 (or worse diagnosis) and hrHPV infection at 12 months after initial treatment.

Sample size: To meet our primary objectives and to achieve a power of 0.8 (α = 0.025), we will need to randomize 126 participants with CIN 2/3, 63 to thermal ablation, and 63 to LEEP. We estimate that this will require screening a total of 4844 women living with HIV.

Estimated dates for completing accrual and presenting results: We anticipate that study accrual will be completed in 3 years (2027), with an additional 18 months to complete all follow-up visits and data analysis. We anticipate presenting results in 2029.

Trial registration: ClinicalTrials.gov #NCT06326294.

Keywords: Cervical Cancer; Loop Electrosurgical Excision Procedure; Low-Resource Settings; Thermal Ablation; Women Living With HIV.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interests None declared.

References

    1. WHO Cervical Cancer Elimination Initiative. Global strategy to accelerate the elimination of cervical cancer as a public health problem. WHO. Nov 17 2020. Oct 30 2024. https://www.who.int/publications/i/item/9789240014107.
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    1. Salcedo MP, Oliveira C, Andrade V, Mariano AAN, Changule D, Rangeiro R, et al. The Capulana study: a prospective evaluation of cervical cancer screening using human papillomavirus testing in Mozambique. Int J Gynecol Cancer. 2020;30(9):1292–7. - PubMed
    1. Salcedo MP, Lathrop E, Osman N, Neves A, Rangeiro R, Mariano AAN, et al. The MULHER Study: cervical cancer screening with primary HPV testing in Mozambique. Int J Gynecol Cancer. 2023;33(12):1869–1874. - PubMed

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