Clinical trial · Interventional
Thermocoagulation for Treatment of Precancerous Cervical Lesions
Cervical Cancer Screening Among HIV-infected Women in Western Kenya: Evaluation of the Safety, Acceptability, and Efficacy of an Alternative Ablation Method for Treatment of Precancerous Lesions
NCT04191967CI-TRIAL-00063404completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the safety, acceptability, and efficacy of Thermocoagulation for treatment of precancerous lesions among HIV-positive women in a screen-and-treat program in Western Kenya.
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 |
| HPV Infection | — | UNRESOLVED | — |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thermocoagulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thermocoagulation
- description
- Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician. Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
- interventionNames
- Device: Thermocoagulation
Primary outcomes (2)
- measure
- Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months
- timeFrame
- 12 months
- description
- The proportion of participants with no evidence of cervical dysplasia at 12-months follow-up, defined as biopsy-confirmed CIN1 result or normal findings, 12-months following treatment.
- measure
- Proportion of Participants With Persistent HPV at 12-month Follow-up
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 25-65 years. 2. Enrolled in HIV care at FACES-supported clinics in Kisumu County. 3. Able to understand a written informed consent document, and willing to sign it. 4. Speaks a language that the consent form and data collection instruments are written in. Exclusion Criteria: 1. Has a history of cervical cancer. 2. Has received any treatment for cervical precancer after screening positive for precancer. 3. Has evidence of cervical infection. 4. Pregnant women are excluded from this study.
References
Publications (3)
- RESULTMungo C, Osongo CO, Ambaka J, Randa MA, Omoto J, Cohen CR, Huchko M. Safety and Acceptability of Thermal Ablation for Treatment of Human Papillomavirus Among Women Living With HIV in Western Kenya. JCO Glob Oncol. 2020 Jul;6:1024-1033. doi: 10.1200/GO.20.00035. PMID 32634066
- DERIVED2022 ASCCP Poster Presentations. J Low Genit Tract Dis. 2022 Apr 1;26(2S):6-13. doi: 10.1097/LGT.0000000000000671. No abstract available. PMID 35350043
- DERIVEDMungo C, Osongo CO, Ambaka J, Randa MA, Samba B, Ochieng CA, Barker E, Guliam A, Omoto J, Cohen CR. Feasibility and Acceptability of Smartphone-Based Cervical Cancer Screening Among HIV-Positive Women in Western Kenya. JCO Glob Oncol. 2021 May;7:686-693. doi: 10.1200/GO.21.00013. PMID 33999653