Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Mungo C

PROVIDER: S-EPMC7392781 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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

Mungo Chemtai C Osongo Cirilus Ogollah CO Ambaka Jeniffer J Randa Magdalene A MA Omoto Jackton J Cohen Craig R CR Huchko Megan M

JCO global oncology 20200701

<h4>Purpose</h4>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).<h4>Methods</h4>Between August 2019 and February 2020, WLWH age 25-65 years underwent human papillomavirus (HPV) self-col ...[more]

PMID: 32634066

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Project description:PurposeAdjunct 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.MethodsHPV-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.ResultsOne 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.ConclusionCervicography 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.

Project description:BackgroundThe World Health Organization recommends thermal ablation as an alternative to cryotherapy to treat women with precancerous lesions in low-resource settings. However, limited data are available on women's experience and adverse events (AEs) of the procedure in the context of Sub-Saharan Africa. The objective of this study was to evaluate the acceptability and safety of thermal ablation in women screened positive for precancerous cervical lesions.MethodsAsymptomatic women aged 30-49 years old living in the Dschang Health District were invited to participate in a cervical cancer screening campaign termed "3 T-Approach" (for Test-Triage and Treat). Recruited women were asked to perform HPV self-sampling followed by triage with visual assessment and treatment with thermal ablation if required. After treatment and 4-6 weeks later, interviews were conducted to assess women's experience on anxiety, discomfort, and pain during thermal ablation. AEs were recorded on pre-defined electronic forms 4-6 weeks after treatment to assess the procedure's safety.ResultsBetween September 2018 and December 2020, 399 HPV-positive women (18.7% of women screened) were recruited, 236 (59.1%) had a positive visual assessment, 234 were treated by thermal ablation and 198 (84.6%) received therapy in the same visit. Treatment was not considered as painful (score ≤ 4/10) by 209 (90.9%) patients while 5 (2.5%) reported high pain (score 8-10/10). During post-treatment interviews 4-6 weeks later, most reported AEs were graded mild or moderate (grade I-II). The most frequent symptoms reported as mild AEs (grade 1-2) were vaginal watery discharge (75.5%), vaginal bloody-stained discharge (21.5%) and malodourous discharge (14.5%). None of the participants experienced serious AEs (grade 3-4) or AEs requiring admission to hospital or emergency consultation. The vast majority of women (99.6%) would agree to repeat the procedure if necessary and (99.6%) would recommend it to friends or family.ConclusionThermal ablation is widely accepted by women and appears as a safe procedure. It may contribute to improving the link between screening and treatment in a single visit and to optimizing cervical cancer control in low-resource settings.Trial registrationThe study was registered on clinicaltrials.gov ( NCT03757299 ) in November 2018 (28/11/2018).

Project description:BACKGROUND:Option B+ is a comprehensive antiretroviral treatment (ART) designed for HIV-infected pregnant/ postpartum women. However, barriers to implementing Option B+ and establishing long-term ART adherence while facilitating retention in prevention of mother to child transmission of HIV (PMTCT) services remain. Community-based mentor mothers (cMMs) who can provide home-based support for PMTCT services may address some of the barriers to successful adoption and retention in Option B+. Thus, we evaluated the acceptability of using cMMs as home-based support for PMTCT services. METHODS:Gender-matched in-depth interviews were conducted between September-November 2014 for HIV-infected pregnant/postpartum women and their male partners living in southwestern Kenya (n?=?40); additionally, we conducted four focus groups involving 30 health workers (n?=?70) within four health facilities. Audio-recordings were transcribed, translated, and then coded using a thematic analytical approach in which data were deductively and inductively coded with support from prior literature, identified themes within the interview guides, and emerging themes from the transcripts utilizing Dedoose software. RESULTS:Overall, the study results suggest high acceptability of cMMs among individual participants and health workers. Stigma reduction, improvement of utilization of health care services, as well as ART adherence were most frequently discussed potential benefits of cMMs. Participants pictured a cMM as someone acting as a role model and confidant, and who was over 30?years old. Many respondents raised concerns about breaches of confidentiality and inadvertent disclosure. Respondent suggestions to overcome these issues included the cMM working in different communities than where she lives and attending home-visits with no identifying clothing as an HIV-related health worker. CONCLUSIONS:The home-based cMM approach may be a beneficial and acceptable strategy for promoting ART adherence and retention within PMTCT services for pregnant/postpartum women living with HIV. Considering the risks of inadvertent disclosure of HIV-infected status and related negative consequences for pregnant/postpartum women living with HIV, similar cMM program designs may benefit from recognizing and addressing these risks. TRIAL REGISTRATION:The MOTIVATE! study was registered on July 7, 2015 at the ClinicalTrials.gov ( NCT02491177 ).

Project description:BackgroundAntiretroviral therapy (ART) assures major gains in health outcomes among people living with HIV, however, this benefit may not be realized by all due to care interruptions. Mobile populations comprise a subgroup that is likely to have sub-optimal care engagement, resulting in discontinuation of ART. We sought to evaluate the barriers to care engagement among highly mobile individuals living with HIV and explore options aimed at improving engagement in care for this group.MethodsQualitative in-depth interviews were conducted in 2020 among a purposive sample of twelve persons living with HIV and eight health care providers in western Kenya, within a mixed methods study of mobility in communities participating in the SEARCH trial (NCT01864603). We explored the barriers to care engagement among mobile individuals living with HIV and explored different options aimed at enhancing care engagement. These included options such as a coded card containing treatment details, alternative drug packaging to conceal drug identity, longer refills to cover travel period, wrist bands with data storage capability to enable data transfer and "warm handoff" by providers to new clinics upon transfer. Data were inductively analyzed to understand the barriers and acceptability of potential interventions to address them.ResultsStigma and lack of disclosure, rigid work schedules, and unpredictability of travel were major barriers to care engagement for highly mobile individuals living with HIV. Additionally, lack of flexibility in clinic schedules and poor provider attitude were identified as health-system-associated barriers to care engagement. Options that enhance flexibility, convenience and access to care were viewed as the most effective means of addressing the barriers to care by both patients and providers. The most preferred option was a coded card with treatment details followed by alternative drug packaging to conceal drug identity due to stigma and longer refills to cover travel periods.ConclusionHighly mobile individuals living with HIV desire responsive, flexible, convenient and patient-centered care delivery models to enhance care engagement. They embraced simple health delivery improvements such as coded cards, alternative drug packaging and longer refills to address challenges of mobility.

Project description:BackgroundFinding HIV infected persons and engaging them in care is crucial in achieving UNAIDS 90-90-90 targets; diagnosing 90% of those infected with HIV, initiating 90% of the diagnosed on ART and achieving viral suppression in 90% of those on ART. To achieve the first target, no person should be left behind in their access to HIV testing services. In Kenya, HIV prevention and testing services give less emphasis on older adults. This article describes HIV testing experiences of older adults living with HIV and how their age shaped their interaction and treatment received during HIV testing and diagnosis.MethodsWe conducted a qualitative study in two HIV clinics (rural and urban) in western Kenya, and recruited 57 HIV infected persons aged ≥50 years. We conducted in depth interviews (IDIs) with 25 participants and 4 focus group discussions (FGDs) with a total of 32 participants and audio recorded all the sessions. Participants recruited were aged between 54 and 79 years with 43% being females. We transcribed audio records and analyzed the data using thematic content analysis method.ResultsOlder persons' experiences with HIV testing depended on where they tested (hospital or community setting); whether they actively sought the testing or not; and the age and gender of the healthcare provider who conducted the test. Participants expressed concerns with ageist discrimination when actively seeking HIV care testing services in hospital settings, characterized by providers' reluctance or refusal to test. The testing and counseling sessions were described as short and hurried within the hospital settings, whereas the interactions with service providers in home-based testing were experienced as appropriate and supportive. Participants in this study expressed preference for healthcare providers who were older and of similar gender.ConclusionHIV testing services are still not tailored to target older adults' needs in our setting resulting in late diagnosis among older persons. We argue that a scale-up of community level testing services that provide adequate testing and counselling time and actively reach out to older adults is key to attaining the UNAIDS targets of having 90% of PLWH know their status.

Project description:IntroductionUnderstanding interests in and preferences for multipurpose technology (MPT) for the co-administration of contraception and antiretroviral therapy (ART) and alternative, non-oral ART methods among women living with HIV (WLHIV) is vital to successful implementation of future treatment options, such as long-acting injectable ART.MethodsBetween May 2016 and March 2017 we conducted a cross-sectional telephone survey of 1,132 WLHIV of reproductive potential with prior experience using intermediate- or long-acting contraceptive methods in western Kenya. We present descriptive statistics and multinomial logistic regression to evaluate predictors of interest in specific MPT and non-oral ART methods.ResultsTwo-thirds (67%) reported interest in MPT, with the most common reason for interest being ease of using a single medication for both purposes of HIV treatment and pregnancy prevention (26%). Main reasons for lack of interest in MPT were need to stop/not use contraception while continuing ART (21%) and risk of side effects (16%). Important characteristics of MPT were effectiveness for pregnancy prevention (26%) and HIV treatment (24%) and less than daily dosing (19%). Important characteristics of non-oral ART methods were less than daily dosing (47%), saving time accessing ART (16%), and effectiveness of HIV treatment (15%). The leading preferred methods for both MPT and non-oral ART were injectables (50 and 54%) and implants (32 and 31%). Prior use of a contraceptive implant or injectable predicted interest in similar methods for both MPT and non-oral ART methods, while this relationship did not appear to vary between younger vs. older WLHIV.DiscussionMost WLHIV in western Kenya are interested in MPT for HIV treatment and contraception. Prior exposure to contraceptive implants or injectables appears to predict interest in similar methods of MPT and non-oral ART. Developers of MPT and non-oral ART methods should strongly consider WLHIV's preferences, including their changing reproductive desires.

Dataset Information

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

Publications

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

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