Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique

NCT06326294 | Recruiting

• 1 other identifier: 727/CNBS/23
• Study Type: interventional
• Target: 4,844
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; HPV Infection; CIN 2/3

Outcome Measures

Primary Outcomes (1)

• Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)

  The treatment success rate (12-month efficacy) of LEEP (pL) and that of ablation (pA) for participants with ablation-eligible CIN 2/3 will be measured by assessing the proportion of patients in each treatment group whose lesions completely regress or are successfully treated without recurrence over a defined follow-up period.

  12 months

Study Arms (2)

Thermo ablation treatment

OTHER

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.

Device: Thermal ablation

LEEP treatment

OTHER

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.

Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE

Interventions

Thermal ablation DEVICE

Thermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the cervical transformation zone and destroy the abnormal epithelium.

Also known as: TA

Thermo ablation treatment

LOOP ELECTROSURGICAL EXCISION PROCEDURE PROCEDURE

Cervical tissue excision

Also known as: LEEP

LEEP treatment

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ages 25-49 years;
• confirmed HIV infection;
• physically and mentally willing and able to participate in the study, and provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Saúde, Mozambique: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

INSMozambique

Maputo, Mozambique

RECRUITING

Related Publications (1)

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

  PMID: 40399211 DERIVED

MeSH Terms

Conditions

HIV Infections; Papillomavirus Infections

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Edna Viegas, MD, PhD

  Instituto Nacional de Saúde, Mozambique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edna Viegas, MD, PhD

CONTACT

+258823060500; edna.viegas@ins.gov.mz

Edna Nhacule, MD

CONTACT

845210269; edna.nhacule@ins.gov.mz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: To compare TA, an ablative cervical treatment modality, and LEEP, an excisional cervical treatment modality, in screen-positive WLWH patients, for eradication of hrHPV and effectiveness of treating biopsy-confirmed CIN 2/3.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 22, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

MO (1)