Acceptability of innovative treatments for cervical pre- cancer in - - PowerPoint PPT Presentation

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Co-Hosted by the National Institutes

• f Health and AcademyHealth

Acceptability of innovative treatments for cervical pre- cancer in LMICs

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Global Burden of Cervical Cancer

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Global Challenges in Detection and Prevention

• Screening of high-grade precancerous lesions

(cervical intraepithelial neoplasia grade 2 or higher [CIN2+]):

• Conventional screening (cytology)
• Innovative primary and secondary prevention

methods (HPV vaccination, HPV testing, self- sampling)

• Treatment of CIN2+

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CIN2+ Treatments Endorsed by WHO

Excision procedures

• LEEP/cold knife cone
• Gold standard
• Requires highly trained

clinician

• Anesthesia
• Potentially serious

complications Ablation procedures

• Gas-based cryotherapy/thermal

ablation

• Cryo is standard treatment in

LMICs (uses cryogenic gas)

• Require minimal training
• No anesthesia, few reported

complications

• Cure rates 77-93% vs. LEEP

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Cryotherapy Challenges

• Procurement of medical-grade CO2 or

N2O gas

• Standard 56lb tank:
• Treats about 25 patients
• Refilling is costly
• Tanks are heavy = very difficult to

transport and store

• Cryo machines require maintenance to

avoid leaks/blockages

• Treatment lasts 10-15 min.

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Potential alternatives to gas-based cryotherapy

• CryoPen
• Non-gas cryotherapy device
• Runs on electricity or car battery
• Requires small amount of ethanol
• Relatively portable
• Treatment lasts about 5min. (single

application)

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Potential alternatives to gas-based cryotherapy

• Thermal ablation (handheld models)
• Uses heat instead of cold
• Runs on electricity or rechargeable

battery

• Very light and portable
• Lack of RCT data (safety and

efficacy)

• Other models in development

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RCT in three LMICs

• 3-arm non-inferiority trial
• 1151 women with biopsy-confirmed CIN2+, return at 6 weeks and at 12 months

post-treatment (have enrolled and randomized 629, 54%)

• Sites: ISSS (San Salvador, El Salvador), HUSI (Bogotá, Colombia), SDH (Shanxi and

Xinxiang provinces, China) Double-freeze CO2- based cryotherapy (3’-5’-3’) Single-freeze CryoPen (5’) Thermal ablation at 100°C (40 sec, followed by 20 sec)

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Measures of acceptability

• Pain during and after treatment
• Survey at 6-weeks post-treatment (structured and open questions)

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Pain during and after treatment, by treatment type

Study Time Point Baseline Before Treatment During Treatment After Treatment Treatment Groups Mean (95%CI) CO2 0.06 (0, 0.12) 1.08 (0.72, 1.43) 2.54 (1.97, 3.11) 1.24 (1.12, 1.36) CryoPen 0.08 (0, 0.15) 1.06 (0.69, 1.42) 2.97 (2.51, 3.69) 1.14 (1.01, 1.26) Thermal ablation 0.12 (0, 0.28) 1.00 (0.70, 1.30) 3.69 (2.77, 4.00) 1.19 (1.07, 1.30) Kruskal-Wallis Rank Test p-value 0.99 0.99 0.001 0.45

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Pain during and after treatment, by site

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Treatment acceptability

Satisfaction with treatment n(%)

Very satisfied 304 (87) Somewhat satisfied 34 (10) Neutral 12 (3) Somewhat dissatisfied Very dissatisfied

Was discomfort acceptable n(%)

Definitely 321 (92) Probably yes 25 (7) Probably no 2 (.5) Definitely no Not sure 1 (.3) Missing 1 (.3)

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Would you recommend treatment to a friend?

Recommend to a friend n(%)

Definitely 532 (93) Probably yes 20 (3.5) Probably no 1 (.1) Definitely no 3 (.5) Not sure 13 (3)

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Open questions – preliminary content analysis

Not painful Comfortable Fast Depends on biopsy results Effective Preventive Improves health Makes me better Non surgery Outpatient Non-invasive No complications Follow-up care

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Lessons learned and future steps

• It’s never too late to include a D&I approach!
• Preliminary data
• Provider acceptability (qualitative assessment)
• New RCT – hybrid(ish) model focused on efficacy, acceptability, and

feasibility of thermal ablation treatment protocols (PI: Cremer)

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THANK YOU!

• Montserrat Soler, PhD MPH
• Ob/Gyn and Women’s Health Institute, Cleveland Clinic
• Basic Health International