"ARVs is for HIV and cream is for HPV or precancer:" Women's Perceptions and Perceived Acceptability of Self-Administered Topical Therapies for Cervical Precancer Treatment: A Qualitative Study from Kenya.

Background: Women in low- and middle-income countries (LMICs) bear a disproportionate burden of global incidence and deaths from cervical cancer, despite being a preventable disease. Prevention efforts in LMICs are hindered in part by lack of access to cervical precancer treatment, due to weak health infrastructure and a lack of adequate human resources to deliver current provider-administered precancer treatments. Innovative strategies are urgently needed to close the cervical precancer treatment gap in LMICs, including the use of self-administered topical therapies for which efficacy evidence is available from high-income settings. We investigated African women's perceptions and perceived acceptability of these therapies for cervical precancer treatment. Methods: Between November 2022 and April 2023, we conducted five focus group discussions (FGDs) with women ages 25-65 years undergoing cervical cancer screening or precancer treatment in Kisumu, Kenya. The FGDs explored women's experiences with screening and precancer treatment, their acceptability of topical therapies for precancer treatment, and perceived barriers and facilitators to uptake. The FGDs were moderated by local qualitative research assistants, conducted in local languages, transcribed, coded, and analyzed using qualitative description using NVIVO software. Results: Twenty-nine women participated, with a mean age of 35.4 years (SD 6.5). All had undergone cervical cancer screening, and 25 (83%) had a history of precancer treatment with ablation or excision. Multiple themes were identified related to women's perceptions of topical therapies. Participants were highly receptive of topical treatments, with many favoring the option of self-administration compared to provider-administration of such therapies. Self-administration of topical therapies was felt to help address challenges associated with current treatment methods, including difficulty in access, pain with procedures, cost, and lack of privacy with pelvic exams. Participants had a preference for topical therapies that are used less frequently compared to those used daily. Conclusions: Among Kenyan women with a history of cervical precancer treatment, self-administered topical therapies for precancer are acceptable and have the potential to address barriers, including access, privacy, and cost, that hinder precancer treatment in LMICs. If supported by efficacy studies in LMICs, self-administered topical therapies offer a scalable approach to closing the precancer treatment gap in LMICs. Trial registration: Not applicable.

A youth-centred approach to improving engagement in HIV services: human-centred design methods and outcomes in a research trial in Kisumu County, Kenya.

IntroductionInnovative interventions are needed to improve HIV outcomes among adolescents and young adults (AYAs) living with HIV. Engaging AYAs in intervention development could increase effectiveness and youth acceptance, yet research is limited. We applied human-centred design (HCD) to refine adherence-support interventions pretrial and assessed HCD workshop acceptability. METHODS: We applied an iterative, four-phased HCD process in Kenya that included: (1) systematic review of extant knowledge, (2) prioritisation of design challenges, (3) a co-creation workshop and (4) translation tables to pair insights with trial intervention adaptations. The co-creation workshop was co-led by youth facilitators employing participatory activities to inform intervention adaptations. Iterative data analysis included rapid thematic analysis of visualised workshop outputs and notes using affinity mapping and dialogue to identify key themes. We conducted a survey to assess workshop acceptability among participants. RESULTS: Twenty-two participants engaged in the 4-day workshop. Co-creation activities yielded recommendations for improving planned interventions (eg, message frequency and content; strategies to engage hard-to-reach participants), critical principles to employ across interventions (eg, personalisation, AYA empowerment) and identification of unanticipated AYA HIV treatment priorities (eg, drug holidays, transition from adolescent to adult services). We revised intervention content, peer navigator training materials and study inclusion criteria in response to findings. The youth-led HCD workshop was highly acceptable to participants. CONCLUSIONS: Research employing HCD among youth can improve interventions preimplementation through empathy, youth-led inquiry and real-time problem solving. Peer navigation may be most influential in improving retention when engagement with young people is based on mutual trust, respect, privacy and extends beyond HIV-specific support. Identifying opportunities for personalisation and adaptation within intervention delivery is important for AYAs. Patient engagement interventions that target young people should prioritise improved transition between youth and adult services, youth HIV status disclosure, AYA empowerment and healthcare worker responsiveness in interactions and episodic adherence interruptions.

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.

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.