Human Immunodeficiency VirusNCT04191967
Thermocoagulation for Treatment of Precancerous Cervical Lesions
A study testing Thermocoagulation in people with Human Immunodeficiency Virus and HPV Infection, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Human Immunodeficiency Virus, HPV Infection, CIN 2/3
- What is being tested?
- Thermocoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteKenya
- Study dates
- 25 Sep 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-65 years.
- Enrolled in HIV care at FACES-supported clinics in Kisumu County.
- Able to understand a written informed consent document, and willing to sign it.
- Speaks a language that the consent form and data collection instruments are written in.
Who cannot join
- Has a history of cervical cancer.
- Has received any treatment for cervical precancer after screening positive for precancer.
- Has evidence of cervical infection.
- Pregnant women are excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Thermocoagulation is endorsed as an alternative to Cryotherapy for treatment of Visual Inspection with Acetic Acid (VIA) or Human Papillomavirus (HPV)-positive women by the 2018 Kenya national cancer guidelines.32 Data primary from Western countries demonstrate similar efficacy for the treatment of precancerous lesions between Cryotherapy and Thermocoagulation. Data on safety, acceptability, and efficacy, particularly linked to gold-standard pathology, among HIV-positive women in low-resource settings are scare. Given the demonstrated benefits over cryotherapy including increased portability and availability hence easier implementation, use of thermal coagulation for the treatment of precancerous lesions in low resource settings could significantly improve access to treatment compared with cryotherapy.
This study seeks to fill a critical data gap by evaluating the efficacy of thermocoagulation among HIV-positive positive women using gold-standard biopsy for disease verification at baseline and follow-up, as indicated. We will also assess the safety and acceptability of this treatment modality among patients and providers
Aim 1: To evaluate the efficacy of thermal coagulation for the treatment of HIV-positive, HPV-positive women by assessing rates of HPV persistence and CIN2/3 rate at 12 months after treatment
Aim 2: To evaluate the safety and acceptability of thermal coagulation for treatment of abnormal cervical lesions within a screen-and-treat program among HIV-positive women in Western Kenya.
Aim 3: Evaluate provider acceptability of thermal coagulation for the treatment of precancerous cervical lesion within a screen-and-treat program in Western Kenya.
Outline:
Counseling on HPV, cervical cancer, and the screening process was offered during routine HIV clinics in group and individual settings. Participants will then be provided self-sampling instructions, a collection kit, and a private area to perform self-collection. The self-collected HPV samples will be labeled, stored, and processed for DNA of 14 high-risk HPV types. HPV-positive participants were invited for a return visit, including a pelvic examination and visual inspection with acetic acid (VIA) to determine eligibility for ablative therapy. After ablation, a questionnaire will be administered to participants to evaluate treatment experience. All participants will be given a 4- to 6-week phone or in-person follow-up appointment, per participant preference
- Conditions
- Human Immunodeficiency Virus, HPV Infection, CIN 2/3
- Being tested
- Thermocoagulation
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermocoagulationDevice
Also called Liger thermocoagulator
Treatment of positive screening results will be performed using the Liger Thermocoagulator device
| Study group | Role | What they receive |
|---|---|---|
| Thermocoagulation | Experimental | 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 Receives: Device: Thermocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months
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.
Measured: 12 months
Proportion of Participants With Persistent HPV at 12-month Follow-up
The proportion of persistence of HPV at follow-up will be reported defined as treatment failure with persistent biopsy-confirmed CIN2/3.
Measured: 12 months
Secondary outcomes (3)
Frequency of Pain Score Category
A 4-point Visual Analog Scale (VAS) for pain assessment was used to evaluate pain immediately after treatment. The pain VAS was comprised of verbal descriptors, one for each symptom extreme. The pain VAS is self-completed by the respondent. The respondent is asked to select the point that represents their pain intensity. The "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Measured: Day of Treatment, approximately 1 day
Percentage of Participants Reporting Treatment-related Adverse Events (AE)
The percentage of participants reporting grade 2 and higher AEs, and severe adverse events (SAEs) during the 4-week follow-up will be reported by event.
Measured: Up to 6 weeks following treatment
Frequency of Positive Participant Satisfaction Responses
Participant satisfaction with thermocoagulation will be evaluated by determining the proportion of participants indicating a response of 'yes' to the question "Do you feel satisfied with the treatment you received?" with an alternative response of 'no' at the 4-6 week follow-up visit.
Measured: Up to 6 weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start25 Sep 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Chemtai Mungo, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191967
- Sponsor's protocol ID
- 19405
- Other IDs
- 5D43TW009343
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2019
- Last updated
- 25 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mungo 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.
PubMed 326340662022 ASCCP Poster Presentations. J Low Genit Tract Dis. 2022 Apr 1;26(2S):6-13. doi: 10.1097/LGT.0000000000000671. No abstract available.
PubMed 35350043Mungo 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.
PubMed 33999653
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04191967
- Acronym / sponsor ID
- 19405
- Conditions
- Human Immunodeficiency Virus, HPV Infection, CIN 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thermocoagulation is endorsed as an alternative to Cryotherapy for treatment of Visual Inspection with Acetic Acid (VIA) or Human Papillomavirus (HPV)-positive women by the 2018 Kenya national cancer guidelines.32 Data primary from Western countries demonstrate similar efficacy for the treatment of precancerous lesions between Cryotherapy and Thermocoagulation. Data on safety, acceptability, and efficacy, particularly linked to gold-standard pathology, among HIV-positive women in low-resource settings are scare. Given the demonstrated benefits over cryotherapy including increased portability and availability hence easier implementation, use of thermal coagulation for the treatment of precancerous lesions in low resource settings could significantly improve access to treatment compared with cryotherapy.
This study seeks to fill a critical data gap by evaluating the efficacy of thermocoagulation among HIV-positive positive women using gold-standard biopsy for disease verification at baseline and follow-up, as indicated. We will also assess the safety and acceptability of this treatment modality among patients and providers
Aim 1: To evaluate the efficacy of thermal coagulation for the treatment of HIV-positive, HPV-positive women by assessing rates of HPV persistence and CIN2/3 rate at 12 months after treatment
Aim 2: To evaluate the safety and acceptability of thermal coagulation for treatment of abnormal cervical lesions within a screen-and-treat program among HIV-positive women in Western Kenya.
Aim 3: Evaluate provider acceptability of thermal coagulation for the treatment of precancerous cervical lesion within a screen-and-treat program in Western Kenya.
Outline:
Counseling on HPV, cervical cancer, and the screening process was offered during routine HIV clinics in group and individual settings. Participants will then be provided self-sampling instructions, a collection kit, and a private area to perform self-collection. The self-collected HPV samples will be labeled, stored, and processed for DNA of 14 high-risk HPV types. HPV-positive participants were invited for a return visit, including a pelvic examination and visual inspection with acetic acid (VIA) to determine eligibility for ablative therapy. After ablation, a questionnaire will be administered to participants to evaluate treatment experience. All participants will be given a 4- to 6-week phone or in-person follow-up appointment, per participant preference
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermocoagulation | Experimental | Device: ThermocoagulationThermal 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 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 25-65 years.
- Enrolled in HIV care at FACES-supported clinics in Kisumu County.
- Able to understand a written informed consent document, and willing to sign it.
- Speaks a language that the consent form and data collection instruments are written in.
Key exclusion criteria (4 listed)
- Has a history of cervical cancer.
- Has received any treatment for cervical precancer after screening positive for precancer.
- Has evidence of cervical infection.
- Pregnant women are excluded from this study.
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 |
|---|---|---|
| ThermocoagulationAlso: Liger thermocoagulatorTreatment of positive screening results will be performed using the Liger Thermocoagulator device | Device | Thermocoagulation |
Primary outcome
Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months
Time frame: 12 months
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.
Proportion of Participants With Persistent HPV at 12-month Follow-up
Time frame: 12 months
The proportion of persistence of HPV at follow-up will be reported defined as treatment failure with persistent biopsy-confirmed CIN2/3.
3 secondary outcomes
Frequency of Pain Score Category
Time frame: Day of Treatment, approximately 1 day
Percentage of Participants Reporting Treatment-related Adverse Events (AE)
Time frame: Up to 6 weeks following treatment
Frequency of Positive Participant Satisfaction Responses
Time frame: Up to 6 weeks following treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32634066Mungo 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.
- Derived from this study: PubMed 353500432022 ASCCP Poster Presentations. J Low Genit Tract Dis. 2022 Apr 1;26(2S):6-13. doi: 10.1097/LGT.0000000000000671. No abstract available.
- Derived from this study: PubMed 33999653Mungo 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chemtai Mungo, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermocoagulation in people with Human Immunodeficiency Virus and HPV Infection, run by University of California, San Francisco at 1 site in Kenya.
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 4 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: finished, as of the sponsor's last update on 25 Jan 2023. 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04191967, which also lists 3 linked publications.
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 25 Jan 2023.