Efficacy of thermal ablation for treatment of biopsy-confirmed high-grade cervical precancer among women living with HIV in Kenya.

The World Health Organization recommends thermal ablation (TA) as an alternative to cryotherapy within "screen-and-treat" cervical cancer programs in low- and middle-income countries (LMICs), including among women living with HIV (WLWH). Data on TA efficacy among WLWH are limited, however. We conducted a clinical trial to evaluate efficacy of TA for treatment of biopsy-confirmed cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3) among WLWH in Kenya. Nonpregnant HPV-positive WLWH age 25 to 65 years underwent colposcopy-directed biopsy, and same-day treatment with TA, if eligible. Women with biopsy-confirmed CIN2/3 at baseline had colposcopy-directed biopsies at 12 months to determine cure. A total of 376 participants underwent TA during the study period. At baseline, 238 (63.3%) had normal histology, 39 (10.4%) had CIN1, 15 (4.0%) had CIN2, 55 (14.6%) had CIN3, 7 (1.9%) had microinvasive cancer and 22 (5.6%) had indeterminate results. Twelve-month follow-up pathology results are available for 59 of 70 (84.3%) participants with CIN2/3 at baseline. Of these, 39 (66.1%, 95% CI 0.54-0.99) had successful treatment, defined as biopsy-confirmed CIN1 or normal findings, while 20 (33.9%, 95% CI 0.22-0.46) had treatment failure, defined as persistent biopsy-confirmed CIN2 or worse. Treatment failure was 23.1% (95% CI 0.17-0.46) and 39.9% (95% CI 0.23-0.51) among women with CIN2 and CIN3 at baseline, respectively. HIV-positive women with CIN2/3 have high rates of treatment failure at 1-year following thermal ablation. This highlights a significant limitation in the current WHO cervical cancer secondary-prevention strategy and calls for strategies to optimize cervical precancer treatment in this population.

Evaluation of video-assisted HPV education in government-supported clinics in Western Kenya.

Despite prevalent preventative methods of human papillomavirus (HPV), cervical cancer remains the foremost cause of cancer-related death among women of reproductive age in Western Kenya. HPV self-sampling is a preventative measure that can improve accessibility and availability to cervical cancer screening. Correct education about HPV is crucial to combating stigma and increasing HPV screening uptake. In this study, we evaluated the workflow impact of a video-assisted HPV education to promote self-sampling in clinical settings in Kisumu, Kenya. We conducted a descriptive workflow study nested in a two-part cluster-randomized control trial in six government-supported health clinics in Kisumu County. We observed the workflow of HPV screening video-assisted and standard health educations. and evaluated community and clinic health assistant facilitation (CCHA), duration, and feasibility of the intervention. Thirty HPV screening-eligible women who participated in the video intervention were recruited for three focus group discussions (FGDs). The FGDs aimed to better understand women's experience with the video screening, their impressions on the content, and feedback about intervention logistics. Across 33 observations, 16.5 women per day watched the educational video at intervention clinics, and 14 women per day heard standard Ministry of Health cervical cancer prevention education talks at control clinics. Sixty-three percent of women participated in HPV self-sampling in the intervention sites, compared to forty-six percent who screened after standard health talks at control sites. The workflow observations identified variable video projection and viewing space, access to power supply, and CCHA availability and ability to utilize the projector as major factors impacting education workflow. Women in FGDs appreciated the video modality, length of video, and education location. HPV video education is a suitable intervention, with further research recommended to determine the viability of sustainably implementing the intervention in a clinic environment. This research is fully funded by the Duke University Global Health Institute.

Integration of cervical cancer screening into HIV/AIDS care in low-income countries: a moral imperative.

Although cervical cancer is preventable, in 2018, approximately 570,000 new cases occurred globally. Cervical cancer disproportionately affects low- and middle-income countries (LMICs), which accounted for 90% of deaths in 2018. Women living with the Human Immunodeficiency Virus (WLWH) are at increased risk of cervical cancer and are in urgent need of prevention. Despite evidence-based guidelines for screening and prevention of cervical cancer, the majority of WLWH in LMICs lack access to cervical cancer screening. Despite tremendous gains made in access to life prolonging antiretroviral therapy for WLWH, most are served by vertical human immunodeficiency virus (HIV) programmes which do not integrate these two crucial services. We present a case of a WLWH, in HIV care for a decade, who was recently diagnosed with preventable, advanced stage cervical cancer.

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

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.

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

PURPOSE: The WHO now recommends thermal ablation as an alternative to cryotherapy within "screen-and-treat" cervical cancer programs in low- and middle-income countries (LMICs). We conducted a safety and acceptability clinical trial of thermal ablation in a Kenyan Ministry of Health hospital among women living with HIV (WLWH; ClinicalTrials.gov identifier: NCT04191967). METHODS: Between August 2019 and February 2020, WLWH age 25-65 years underwent human papillomavirus (HPV) self-collection in western Kenya. HPV-positive women underwent visual inspection with acetic acid, biopsy, and treatment with thermal ablation performed by a nonphysician clinician, if eligible by standard guidelines. A questionnaire was administered after treatment to assess for pain and treatment acceptability. Adverse events (AEs) were evaluated 4-6 weeks after treatment with a standardized grading tool. RESULTS: A total of 293 HPV-positive WLWH underwent thermal ablation in the study period. The mean age was 40.4 years (standard deviation, 8.7 years). After treatment, 15 (5.1%), 231 (78.8%), 42 (14.3%), and 5 (1.8%) reported none, mild, moderate, and severe pain with treatment, respectively. At follow-up, spotting, vaginal discharge, and pelvic pain were reported by 99 (37.8%), 258 (98.5%), and 46 (17.6%), respectively, for a median of 3.3 (interquartile range [IQR], 2-3), 14 (IQR, 7-21), and 7 (IQR, 3-7) days, respectively. Most participants graded their AEs as mild (grade 1): 94 (95.0%) for bleeding, 125 (48.5%) for vaginal discharge, and 37 (80.4%) for pelvic pain. No grade 3 or 4 AEs were reported. The vast majority (99.2%) were satisfied with the treatment and would recommend it to a friend. CONCLUSION: Thermal ablation performed by nonphysicians in the public health sector in Kenya proved safe and highly acceptable in treating HPV-positive WLWH.