Safety and Acceptability of Thermal Ablation for Treatment of Human Papillomavirus Among Women Living With HIV in Western Kenya

Mungo, Chemtai; Osongo, Cirilus Ogollah; Ambaka, Jeniffer; Randa, Magdalene; Omoto, Jackton; Cohen, Craig R.; Huchko, Megan J.

doi:10.1200/go.20.00035

Cited by 12 publications

(24 citation statements)

References 18 publications

(49 reference statements)

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“…Our study was not powered to evaluate the effectiveness of thermal ablation. As in other studies, thermal ablation did not cause any significant side effects, and the most common side effects were abnormal vaginal discharge and light vaginal bleeding 20,30‐32 . These reported side effects are comparable and less common than those reported for cryotherapy, the most widely used ablative therapy for CIN in sub‐Saharan Africa 33 …”

Section: Discussionsupporting

confidence: 59%

“…As in other studies, thermal ablation did not cause any significant side effects, and the most common side effects were abnormal vaginal discharge and light vaginal bleeding. 20,[30][31][32] These reported side effects are comparable and less common than those reported for cryotherapy, the most widely used ablative therapy for CIN in sub-Saharan Africa. 33 False VIA-positive results were high among our study population; 20 (69%) of 29 VIA-positive women with histologic results did not have CIN.…”

Section: Discussionmentioning

confidence: 75%

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Uptake and safety of community‐based “screen‐and‐treat” with thermal ablation preventive therapy for cervical cancer prevention in rural Lilongwe, Malawi

Chinula

Topazian

Mapanje³

et al. 2021

Intl Journal of Cancer

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Malawi has the highest invasive cervical cancer (ICC) mortality rate worldwide, and ICC is the leading cause of cancer death among women. In 2004, Malawi adopted visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy.However, screening coverage has remained low (<30%) and few women (<50%) who require ablative treatment receive it. Additional barriers include long distances to health facilities and challenges with maintaining gas supplies. Thermal ablation is a safe and effective alternative to cryotherapy. We assessed the safety and uptake of community-based ICC screening with VIA and same-day treatment using a handheld thermocoagulator (HTU) in rural Malawi. We held educational talks alongside community leaders and conducted VIA screening in nonclinic community settings to nonpregnant women aged 25 to 49 years without history of hysterectomy or genital cancer/precancer. Eligible women received same-day thermal ablation and HIV testing/counseling. We collected cervical biopsies before treatment and followed up women at Weeks 6 and 12, with repeat biopsy at Week 12. Between July and August 2017, 408 (88%) of 463 eligible women underwent VIA. Overall, 7% (n = 30) of women had a positive VIA, of whom 93% (n = 28) underwent same-day thermal ablation. Among the 30 VIA-positive women, 5 had cervical intraepithelial neoplasia (CIN) 1, 4 had CIN 2/3 and 21 had benign histologic findings. Abnormal vaginal discharge (60%) and light vaginal bleeding (52%) were the most reported adverse events. There was high uptake of the community-based ICC screening in the study population and treatment was safe in this setting. Similar strategies that minimize false-positive results are urgently needed in Malawi. K E Y W O R D S community-based screening, invasive cervical cancer, screen-and-treat, thermal ablation, VIA 1 | INTRODUCTION Cervical cancer is the fourth most common cancer among women worldwide. In 2018, invasive cervical cancer (ICC) caused 311 000 deaths with Abbreviations: CAB, Community Advisory Board; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; HTU, handheld thermocoagulation; ICC, invasive cervical cancer;

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Section: Discussionsupporting

confidence: 59%

Section: Discussionmentioning

confidence: 75%

Uptake and safety of community‐based “screen‐and‐treat” with thermal ablation preventive therapy for cervical cancer prevention in rural Lilongwe, Malawi

Chinula

Topazian

Mapanje³

et al. 2021

Intl Journal of Cancer

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“…After removing duplicates, 1336 were uploaded to Covidence for abstract and title screening. Two independent reviewers identified 64 papers for full text evaluation of which 12 were found to meet all inclusion criteria for this review 9–11 18–26. Of note, 30 papers were identified as abstracts from conference proceedings with no full text available at that time.…”

Section: Resultsmentioning

confidence: 99%

Side effects and acceptability measures for thermal ablation as a treatment for cervical precancer in low-income and middle-income countries: a systematic review and meta-synthesis

et al. 2022

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ObjectiveUnderstanding the side effects and acceptability of thermal ablation (TA) is necessary before large-scale application in screen-and-treat programmes can be justified in low-income and middle-income countries (LMICs).DesignArticles were selected for inclusion by two independent reviewers. Risk of bias was assessed using the Downs and Black’s criteria. Summary data were extracted, and authors contacted for data when necessary. Proportions of interest and 95% CIs were estimated using a random effects model. Subgroup analysis was performed based on place of treatment and timing of post-treatment follow-up. Heterogeneity was estimated using the I2.Eligibility criteriaStudies that reported one or more side effects or patient acceptability measures after treatment of the cervix using TA in women living in LMICs who completed a cervical cancer screening test. Included articles were clinical trials or observational studies available in English and published before 18 December 2020.Information sourcesOvid MEDLINE, EMBASE, CINAHL, CAB Global Health and WHO Global Index Medicus were searched for this systematic review and meta-synthesis.ResultsA total of 1590 abstracts were screened, 84 full text papers reviewed and 15 papers selected for inclusion in the qualitative review, 10 for meta-synthesis (N=2039). Significant heterogeneity was found in screening tests used to identify women eligible for TA and in methods to ascertain side effects. The most commonly reported side effect during treatment was pain (70%, 95% CI 52% to 85%; I2=98.01%) (8 studies; n=1454). No women discontinued treatment due to pain. At treatment follow-up, common side effects included vaginal discharge (72%, 95% CI 18% to 100%; I2=99.55%) (5 studies; n=771) and bleeding (38%, 95% CI 15% to 64%; I2=98.14%) (4 studies; n=856). Satisfaction with treatment was high in 99% (95% CI 98% to 100%; I2=0.00%) of women (3 studies; n=679).ConclusionsTA results in a number of common side effects, though acceptability remains high among women treated in LMICs. Standardised side effect and acceptability reporting are needed as TA becomes more readily available.PROSPERO registration numberCRD42020197605.

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“…4 , 29 As part of a clinical trial (ClinicalTrials.gov identifier: NCT04191967 ), all HPV-positive women undergo colposcopy-directed biopsy for histopathology diagnosis before treatment. Eligibility criteria of this trial has previously been described, 30 which excluded pregnant women. In this analysis, HPV-positive women of 25-49 years of age participating in this clinical trial were included.…”

Section: Methodsmentioning

confidence: 99%

Feasibility and Acceptability of Smartphone-Based Cervical Cancer Screening Among HIV-Positive Women in Western Kenya

Mungo

Osongo²,

Ambaka³

et al. 2021

JCO Global Oncology

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PURPOSE Adjunct cervical cancer screening methods are under evaluation to improve the diagnostic accuracy of human papillomavirus (HPV)-based screening in low- and middle-income countries. We evaluated the feasibility and acceptability of smartphone-based cervicography among HPV-positive women living with HIV (WLWH) in Western Kenya. METHODS HPV-positive WLWH of 25-49 years of age enrolled in a clinical trial (ClinicalTrials.gov identifier: NCT04191967 ) had digital images of the cervix taken using a smartphone by a nonphysician provider following visual inspection with acetic acid. All participants had colposcopy-directed biopsy before treatment. Cervical images were evaluated by three off-site colposcopists for quality, diagnostic utility, and assigned a presumed diagnosis. We determined the proportion of images rates as low, medium, or high quality, interobserver agreement using Cohen’s Kappa statistic, and the off-site colposcopist’s sensitivity and specificity for diagnosis of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with histopathology. Acceptability was evaluated using a questionnaire. RESULTS One hundred sixty-four HPV-positive WLWH underwent cervicography during the study period. Mean age was 37.3 years. Images from the first 94 participants were evaluated by off-site colposcopists, with a majority (70.9%) rated as high quality. Off-site colposcopists had a sensitivity ranging from 21.4% (95% CI, 0.06 to 0.43) to 35.7% (95% CI, 0.26 to 0.46) and a specificity between 85.5% (95% CI, 0.81 to 0.90) to 94.9% (95% CI, 0.92 to 0.98) for diagnosis of CIN2+ based compared with histopathology. The majority of women, 99.4%, were comfortable having an image of their cervix taken as part of screening. CONCLUSION Cervicography by a nonphysician provider as an adjunct to HPV-based screening among WLWH in a low- and middle-income country setting is feasible and acceptable. However, low sensitivity for diagnosis of CIN2+ by off-site expert colposcopists highlights the limitations of cervicography.

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Safety and Acceptability of Thermal Ablation for Treatment of Human Papillomavirus Among Women Living With HIV in Western Kenya

Cited by 12 publications

References 18 publications

Uptake and safety of community‐based “screen‐and‐treat” with thermal ablation preventive therapy for cervical cancer prevention in rural Lilongwe, Malawi

Uptake and safety of community‐based “screen‐and‐treat” with thermal ablation preventive therapy for cervical cancer prevention in rural Lilongwe, Malawi

Side effects and acceptability measures for thermal ablation as a treatment for cervical precancer in low-income and middle-income countries: a systematic review and meta-synthesis

Feasibility and Acceptability of Smartphone-Based Cervical Cancer Screening Among HIV-Positive Women in Western Kenya

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