Thermocoagulation for Treatment of Precancerous Cervical Lesions
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Thermocoagulation Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive women |
Device: Thermocoagulation
Treatment of positive screening results will be performed using the Liger Thermocoagulator device
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of women with no evidence of cervical dysplasia at 12-months [12 months]
The proportion of women with no evidence of cervical dysplasia at 12-months follow-up, including 95% confidence intervals. We will extrapolate the rate of disease among those with normal colposcopy based on the rate of disease among the 25% in this group who will receive biopsy, and this will be incorporated in calculating persistence. We will perform a logistic regression to examine predictors of treatment success, using clinical and demographic variables as predictor variables.
- Proportion of women with persistent HPV at 12-month follow-up [12 months]
We will also report the rate of persistence of HPV at follow-up and compare with rates reported in the literature in this same population. We will compare efficacy rates for clearance of CIN2/3 to historical results following cryotherapy treatment in similar settings. A one-sample exact test will be used to compare the obtained efficacy proportion to that of historical controls.
Secondary Outcome Measures
- Average pain score on the pain VAS [Day of Treatment, approximately 1 day]
The average pain score and confidence intervals will be calculated immediately after treatment, as reported using the Visual analog scale (VAS) for pain assessment. The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between 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) (11). Normative values are not available.
- Rate of Adverse Events (AE) [Up to 6 weeks following treatment]
We will determine the proportion of women who experience grade 2 and 3 AEs, and severe adverse events (SAEs) during follow-up and calculate confidence intervals. Rates of AEs and SAEs will be compared to published rates for cryotherapy amongst this population (2.1% with mild pain or cramping, 1.6%with malodorous excessive vaginal discharge, 0.7% with mild bleeding or spotting, and no severe adverse events)
- Frequency of Patient Satisfaction Responses [Up to 6 weeks following treatment]
Patient 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 25-65 years.
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Enrolled in HIV care at FACES-supported clinics in Kisumu County.
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Able to understand a written informed consent document, and willing to sign it.
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Speaks a language that the consent form and data collection instruments are written in.
Exclusion Criteria:
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Has a history of cervical cancer.
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Has received any treatment for cervical precancer after screening positive for precancer.
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Has evidence of cervical infection.
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Pregnant women are excluded from this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kenya Medical Research Institute | Kisumu | Kenya |
Sponsors and Collaborators
- University of California, San Francisco
- National Institutes of Health (NIH)
- Fogarty International Center of the National Institute of Health
Investigators
- Principal Investigator: Chemtai Mungo, MD, MPH, University of California, San Francisco
Study Documents (Full-Text)
More Information
Publications
None provided.- 19405
- 5D43TW009343