1 Co-Hosted by the National Institutes of Health and AcademyHealth Acceptability of innovative treatments for cervical pre- cancer in LMICs
Global Burden of Cervical Cancer 2
Global Challenges in Detection and Prevention 3 • 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+
CIN2+ Treatments Endorsed by WHO 4 Ablation procedures Excision procedures • Gas-based cryotherapy/thermal • LEEP/cold knife cone ablation • Gold standard • Cryo is standard treatment in • Requires highly trained LMICs (uses cryogenic gas) clinician • Require minimal training • Anesthesia • No anesthesia, few reported • Potentially serious complications complications • Cure rates 77-93% vs. LEEP
Cryotherapy Challenges 5 • Procurement of medical-grade CO 2 or N 2 O 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.
Potential alternatives to gas-based cryotherapy 6 • CryoPen • Non-gas cryotherapy device • Runs on electricity or car battery • Requires small amount of ethanol • Relatively portable • Treatment lasts about 5min. (single application)
Potential alternatives to gas-based cryotherapy 7 • 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
RCT in three LMICs 8 -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 CO 2 - Thermal ablation at Single-freeze CryoPen based cryotherapy 100 °C (40 sec, followed (5’) by 20 sec) (3’-5’-3’)
Measures of acceptability 9 • Pain during and after treatment • Survey at 6-weeks post-treatment (structured and open questions)
Pain during and after treatment, by treatment type 10 Study Time Point Baseline Before During After Treatment Treatment Treatment Treatment CO 2 0.06 1.08 2.54 1.24 Groups (0, 0.12) (0.72, 1.43) (1.97, 3.11) (1.12, 1.36) Mean CryoPen 0.08 1.06 2.97 1.14 (95%CI) (0, 0.15) (0.69, 1.42) (2.51, 3.69) (1.01, 1.26) Thermal 0.12 1.00 3.69 1.19 ablation (0, 0.28) (0.70, 1.30) (2.77, 4.00) (1.07, 1.30) Kruskal-Wallis p-value 0.99 0.99 0.001 0.45 Rank Test
Pain during and after treatment, by site 11
Treatment acceptability 12 Satisfaction with treatment n(%) Was discomfort acceptable n(%) Very satisfied 304 (87) Definitely 321 (92) Somewhat satisfied 34 (10) Probably yes 25 (7) Neutral 12 (3) Probably no 2 (.5) Somewhat dissatisfied 0 Definitely no 0 Very dissatisfied 0 Not sure 1 (.3) Missing 1 (.3)
Would you recommend treatment to a friend? 13 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)
Open questions – preliminary content analysis 14 Effective Not painful Preventive Improves health Comfortable Makes me better Fast Depends on Non surgery No complications biopsy results Outpatient Follow-up care Non-invasive
Lessons learned and future steps 15 • 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)
16 THANK YOU! • Montserrat Soler, PhD MPH • Ob/Gyn and Women’s Health Institute, Cleveland Clinic • Basic Health International
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