HIV InfectionsNCT06326294
Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
A study testing Thermal ablation and LOOP ELECTROSURGICAL EXCISION PROCEDURE in people with HIV Infections and HPV Infection, run by Instituto Nacional de Saúde, Mozambique at 1 site in Mozambique.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- HIV Infections, HPV Infection, CIN 2/3
- What is being tested?
- Thermal ablation and LOOP ELECTROSURGICAL EXCISION PROCEDURE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,844 participants
- Where
- 1 siteMozambique
- Study dates
- 17 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ages 25-49 years;
- confirmed HIV infection;
- physically and mentally willing and able to participate in the study, and provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mozambique1 site, 1 recruiting
- Recruiting
INSMozambique
Maputo
Edna Viegas, MD,PhD, +258823060500, edna.viegas@ins.gov.mz
Edna Nhacule, MD, +258827460555, edna.nhacule@ins.gov.mz
About this study
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
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.
Read the detailed description
- General purpose:
The goal of this study is 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.
- Specific purposes
Primary Objectives:
- Compare the effectiveness of treating biopsy-confirmed CIN 2/3 by TA versus LEEP
- Compare the effectiveness of treating hrHPV infection by TA versus LEEP
- Assess pain and side effects/adverse events due to TA versus LEEP
Secondary Objectives:
- Identify the determinants of treatment failures
- Develop a deep learning-based automated visual evaluation tool that predicts treatment failure
- Conditions
- HIV Infections, HPV Infection, CIN 2/3
- Being tested
- Thermal ablation, LOOP ELECTROSURGICAL EXCISION PROCEDURE
- Medical subject headings
- HIV Infections, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablationDevice
Also called TA
Thermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the cervical transformation zone and destroy the abnormal epithelium.
LOOP ELECTROSURGICAL EXCISION PROCEDUREProcedure or surgery
Also called LEEP
Cervical tissue excision
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start17 Apr 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 4,844 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Saúde, Mozambique
- Sponsor type
- Other government
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Edna Viegas, MD, PhD, Principal investigator, Instituto Nacional de Saúde, Mozambique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326294
- Sponsor's protocol ID
- 727/CNBS/23
- Status last verified
- May 2024
- First submitted
- 27 Feb 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Jan;36(1):101905. doi: 10.1016/j.ijgc.2025.101905. Epub 2025 Apr 26.
PubMed 40399211
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06326294
- Acronym / sponsor ID
- 727/CNBS/23
- Conditions
- HIV Infections, HPV Infection, CIN 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,844 participants (estimated)
- Lead sponsor
- Instituto Nacional de Saúde, MozambiqueOther government
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- General purpose:
The goal of this study is 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.
- Specific purposes
Primary Objectives:
- Compare the effectiveness of treating biopsy-confirmed CIN 2/3 by TA versus LEEP
- Compare the effectiveness of treating hrHPV infection by TA versus LEEP
- Assess pain and side effects/adverse events due to TA versus LEEP
Secondary Objectives:
- Identify the determinants of treatment failures
- Develop a deep learning-based automated visual evaluation tool that predicts treatment failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thermo ablation treatment | Other | Device: Thermal ablationParticipants 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. |
| LEEP treatment | Other | Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDUREParticipants 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. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ages 25-49 years;
- confirmed HIV infection;
- physically and mentally willing and able to participate in the study, and provide informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ablationAlso: TAThermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the cervical transformation zone and destroy the abnormal epithelium. | Device | Thermo ablation treatment |
| LOOP ELECTROSURGICAL EXCISION PROCEDUREAlso: LEEPCervical tissue excision | Procedure or surgery | LEEP treatment |
Primary outcome
Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 40399211Fallah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edna Viegas, MD, PhD principal investigator
Instituto Nacional de Saúde, Mozambique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal ablation and LOOP ELECTROSURGICAL EXCISION PROCEDURE in people with HIV Infections and HPV Infection, run by Instituto Nacional de Saúde, Mozambique at 1 site in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edna Viegas, MD, PhD (+258823060500, edna.viegas@ins.gov.mz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.