Measuring the performance of HIV self-testing at private pharmacies in Kenya: a cross-sectional study.

INTRODUCTION: HIV self-testing (HIVST) has the potential to support daily oral pre-exposure prophylaxis (PrEP) delivery in private pharmacies, but many national guidelines have not approved HIVST for PrEP dispensing. In Kenya, pharmacy providers are permitted to deliver HIVST, but often do not have the required certification to deliver rapid diagnostic testing (RDT). We estimated the performance of provider-delivered HIVST compared to RDT, the standard of care for PrEP delivery, at private pharmacies in Kenya to inform decisions on the use of HIVST for PrEP scale-up. METHODS: At 20 pharmacies in Kisumu County, we trained pharmacy providers (pharmacists and pharmaceutical technologists) on blood-based HIVST use and client assistance (if requested). We recruited pharmacy clients purchasing sexual and reproductive health-related products (e.g. condoms) and enrolled those ≥18 years with self-reported behaviours associated with HIV risk. Enrolled clients received HIVST with associated provider counselling, followed by RDT by a certified HIV testing services (HTS) counsellor. Pharmacy providers and clients independently interpreted HIVST results prior to RDT (results interpreted only by the HTS counsellor). We calculated the sensitivity and specificity of pharmacy provider-delivered HIVST compared to HTS counsellor-administered RDT. RESULTS: Between March and June 2022, we screened 1691 clients and enrolled 1500; 64% (954/1500) were female and the median age was 26 years (IQR 22-31). We additionally enrolled 40 providers; 42% (17/40) were pharmacy owners and their median years of experience was 6 (IQR 4-10). The majority (79%, 1190/1500) of clients requested provider assistance with HIVST and providers spent a median of 20 minutes (IQR 15-43) with each HIVST client. The sensitivity of provider-delivered HIVST at the pharmacy was high when interpreted by providers (98.5%, 95% CI 97.8%, 99.1%) and clients (98.8%, 95% CI 98.0%, 99.3%), as was the specificity of HIVST in this setting (provider-interpretation: 96.9%, 95% CI 89.2%, 99.6%; client-interpretation: 93.8%, 95% CI 84.8%, 98.3%). CONCLUSIONS: When compared to the national HIV testing algorithm, provider-delivered blood-based HIVST at private pharmacies in Kenya performed well. These findings suggest that blood-based HIVST may be a useful tool to support PrEP initiation and continuation at private pharmacies and potentially other community-based delivery settings.

Views of the taught and the teachers on medical ethics teaching in two universities in Kenya.

Medical or clinical ethics provides guidance for health practitioners and has, hopefully, been taught to medical students during training. The teaching of clinical/medical ethics is more important in the current times because of advances in medical science and the different cultural and socioeconomic circumstances in which medicine is practised. This study sought to determine if and how clinical/medical ethics was taught at two Kenyan medical schools by conducting focus group discussions with undergraduate students and key informant interviews with lecturers teaching ethics and academic administrators. While medical/clinical ethics is a part of the medical curriculum approved by the Kenya Medical and Dental Practitioners Council (Board) and is taught during the training, we identified a gap between the theory and application of ethics education. Undergraduates, medical school administrators and lecturers from both institutions acknowledged a lack of role models and mentors, and a need for further training in communication skills since medical ethics has not been made an examinable subject and there has been no formal requirement for training of lecturers teaching ethics. For the short-term, these gaps can be addressed by training lecturers in medical/clinical ethics, and identifying and utilising suitable reference materials, while long-term measures include developing context-appropriate materials for teaching, in addition to nurturing mentorship skills among lecturers for ethical role modeling.

Short Communication: Awareness of HIV Self-Care Interventions Across Global Regions: Results from a Values and Preferences Survey.

The high burden of HIV in sub-Saharan Africa places significant demands on health care services. Interventions such as HIV self-testing, and pre- and post-exposure prophylaxis (PrEP and PEP) could empower individuals to determine their HIV status and prevent HIV acquisition. In 2018, the World Health Organization disseminated an online, anonymous, global values and preferences survey to adults 18 years of age and older. The survey aimed to inform guidance on awareness, use, and preferences around self-care interventions for sexual and reproductive health. We conducted a cross-sectional analysis using Pearson's chi-squared test to compare awareness of HIV self-testing, PrEP and PEP across five global regions. Our analysis included 814 participants from 110 countries. We noted that respondents from Africa reported higher awareness of HIV interventions than participants from Europe, Latin America and the Caribbean, North America, and Asia. Our finding highlights an opportunity to expand self-care interventions for HIV prevention and management in Africa.

Developing a framework to describe stigma related to cervical cancer and HPV in western Kenya.

BACKGROUND: Despite a high prevalence of human papillomavirus (HPV) and cervical cancer in low and middle-income countries, stigma remains an issue. Addressing HPV and cervical cancer stigma could significantly improve health outcomes for these conditions. The objective of this study was to identify the manifestations of stigma and their potential impacts on health-seeking behavior. METHODS: Twenty-six in-depth interviews were conducted with women living with HIV, HIV-negative women, community health volunteers, and health care providers in Kisumu, Kenya in 2019. The interviews were designed to draw out existing attitudes or experiences related to stigma within the community. We conducted a thematic analysis of the interviews to identify internalized, anticipated, and discriminatory attitudes. RESULTS: Within internalized attitudes, a prominent observed theme was a fear of death associated with a positive HPV test. This stemmed from a lack of understanding of differences between HPV and cervical cancer and posed a significant barrier for women deciding to seek screening or to continue with treatment. Discriminatory attitudes of community members, including assumptions of promiscuity, infidelity, or HIV status, were perceived to prevent women from accessing screening and treatment opportunities. The interviews also exhibited a limited awareness of HPV in this region, which may have contributed to a lack of enacted stigma towards people living with HPV or cervical cancer. CONCLUSION: Stigma has the potential to lead to decreased screening and treatment uptake through its drivers. This includes a decreased perception of personal risk due to a lack of knowledge, which results in increased HPV-risk behaviors. Future research must focus on creating and integrating stigma-reducing interventions, primarily to encourage women to seek out primary and secondary preventative measures.

Behavioral Interventions can Mitigate Adverse Pregnancy Outcomes Among Women Conceiving on ART and Those Initiated on ART During Pregnancy: Findings From the MOTIVATE Trial in Southwestern Kenya.

BACKGROUND: Antiretroviral therapy (ART) is essential for the elimination of mother-to-child transmission and improved health outcomes for women living with HIV (WLWH). However, adverse pregnancy outcomes (APOs) among pregnant women on ART are a growing concern. METHODS: We investigated the associations between timing of ART initiation and APOs among pregnant WLWH receiving behavioral interventions (community mentor mothers and text messaging) in the Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study in southwestern Kenya. Log binomial models were used for estimation of relative risks (RRs) (adjusted for the clustered nature of data) evaluating APOs with 3 exposure comparisons: (1) preconception ART initiation vs. postconception initiation; (2) among postconception ART initiating women, comparisons across gestational ages at cART initiation (first versus second and third trimester exposure), and (3) intervention allocation. RESULTS: Of the 1275 women included in this analysis, 388 (30%) had an APO: 306 preterm births, 38 low birth weight infants, 33 stillbirths, and 11 miscarriages. In multivariable analysis, viral load ≥1000 copies/mL, moderate and severe anemia at baseline increased risk of APOs. Among women initiating ART before and after conception, no difference was observed in the composite APO. Women who received community mentor mother visits alone (aRR 0.74: 95% CI: 0.71 to 0.76) or text messages alone (aRR 0.79: 95% CI: 0.70 to 0.89) had lower risks of experiencing any APOs. CONCLUSIONS: Receiving supportive behavioral interventions may mitigate the risk of experiencing an APO among WLWH on ART. Further studies are needed to investigate the underlying mechanisms and optimize the benefits of these interventions.

The impact of the COVID-19 pandemic response on other health research.

While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended entirely because of either COVID-19-related legal restrictions or logistical, staffing or operational concerns. Billions of people globally are currently affected by lockdowns or curfews. Since the timescale of such restrictive measures is unknown and subject to change, many studies are now in limbo and the welfare of tens of thousands of study participants is at risk. These circumstances have introduced complex ethical challenges that merit urgent attention from international sponsors, researchers and regulators. Certain sponsors and regulators have published guidelines on how the COVID-19-related disruptions to clinical research should be managed. Although these guidelines provide a good starting point in navigating the challenges of the evolving pandemic, they only apply to those researchers funded or governed by these bodies. Here, we provide guidelines on managing such disruptions that apply beyond these specific settings. We highlight some of the effects of the COVID-19 pandemic on other ongoing research projects that are unrelated to COVID-19 and provide practical guidance on how the welfare of affected study participants should be managed. We conclude that policy-makers, sponsors, researchers and regulators must adopt a more flexible approach to ensure participant safety, while maintaining data integrity and complying with good clinical practices.

Pendant que les gouvernements se concentrent sur les profonds bouleversements que la maladie à coronavirus 2019 (COVID-19) engendre pour l'économie mondiale ainsi que sur l'urgence des recherches qui y sont consacrées, d'autres études sont touchées de plein fouet par la pandémie. Plusieurs travaux de recherche d'importance majeure, sans lien avec la COVID-19, ont considérablement ralenti ou ont été totalement interrompus. Soit en raison des restrictions légales relatives à la COVID-19, soit à cause de problèmes logistiques, opérationnels ou d'effectifs. En ce moment, des milliards de personnes à travers le monde sont soumises à un confinement ou un couvre-feu. Comme la durée de telles mesures restrictives est inconnue et susceptible de changer, de nombreuses études sont actuellement en suspens et le bien-être de dizaines de milliers de participants est menacé. Ces circonstances particulières ont entraîné des défis éthiques complexes, qui requièrent une attention immédiate de la part des promoteurs, chercheurs et organismes de réglementation internationaux. Certains promoteurs et organismes de réglementation ont publié des directives sur la manière de gérer les interruptions de recherches cliniques dues à la COVID-19. Elles offrent un bon point de départ pour négocier les écueils au fil de l'évolution de la pandémie, mais elles ne s'appliquent qu'aux chercheurs financés ou administrés par ces instances. Dans le présent document, nous proposons donc des directives destinées à mieux gérer de telles interruptions, au-delà de ce cadre spécifique. Nous soulignons quelques-uns des effets de la pandémie de COVID-19 sur d'autres projets de recherche en cours qui n'ont aucun rapport avec la maladie, et nous donnons des conseils pratiques sur la manière de garantir le bien-être des participants aux études concernées. Enfin, nous parvenons à la conclusion que les législateurs, promoteurs, chercheurs et organismes de réglementation doivent adopter une approche plus souple, afin d'assurer la sécurité des participants tout en préservant l'intégrité des données et en respectant les bonnes pratiques cliniques.

Mientras que los gobiernos se han centrado en la perturbación sin precedentes de la economía global que la enfermedad del coronavirus 2019 (COVID-19) ha causado y en la urgente necesidad de investigar sobre esta enfermedad, otras investigaciones sanitarias se han convertido en víctimas de la pandemia. Las principales actividades de investigación que no están relacionadas con la COVID-19 se han reducido de manera significativa o se han suspendido por completo debido a las restricciones legales relacionadas con la COVID-19 o a los problemas logísticos, de personal u operativos. En la actualidad, el confinamiento o los toques de queda afectan a miles de millones de personas en todo el mundo. Muchos estudios se encuentran ahora en el limbo y el bienestar de decenas de miles de sus participantes está en peligro debido a que se desconoce el calendario de esas medidas restrictivas y está sujeto a cambios. Estas circunstancias han planteado desafíos éticos complejos que merecen una atención urgente por parte de los patrocinadores, los investigadores y los organismos reguladores internacionales. Algunos patrocinadores y organismos reguladores han publicado pautas sobre cómo se deben gestionar las perturbaciones relacionadas con la COVID-19 en la investigación clínica. Aunque estas pautas constituyen un buen punto de partida para hacer frente a los desafíos de la pandemia que está evolucionando, solo se aplican a los investigadores que son financiados o gestionados por estos organismos. En este documento, se ofrecen pautas para gestionar esas perturbaciones que se extienden más allá de estos entornos específicos. Se resaltan algunos de los efectos de la pandemia de la COVID-19 en otros proyectos de investigación en curso que no están relacionados con esta enfermedad y se proporcionan pautas prácticas sobre cómo se debe gestionar el bienestar de los participantes afectados en el estudio. Se concluye que los responsables de formular las políticas, los patrocinadores, los investigadores y los organismos reguladores deben adoptar un enfoque más flexible para garantizar la seguridad de los participantes, al tiempo que se mantiene la integridad de los datos y se cumplen las buenas prácticas clínicas.

Challenges to generating political prioritization for adolescent sexual and reproductive health in Kenya: A qualitative study.

BACKGROUND: Despite the high burden of adverse adolescent sexual and reproductive health (SRH) outcomes, it has remained a low political priority in Kenya. We examined factors that have shaped the lack of current political prioritization of adolescent SRH service provision. METHODS: We used the Shiffman and Smith policy framework consisting of four categories-actor power, ideas, political contexts, and issue characteristics-to analyse factors that have shaped political prioritization of adolescent SRH. We undertook semi-structured interviews with 14 members of adolescent SRH networks between February and April 2019 at the national level and conducted thematic analysis of the interviews. FINDINGS: Several factors hinder the attainment of political priority for adolescent SRH in Kenya. On actor power, the adolescent SRH community was diverse and united in adoption of international norms and policies, but lacked policy entrepreneurs to provide strong leadership, and policy windows were often missed. Regarding ideas, community members lacked consensus on a cohesive public positioning of the problem. On issue characteristics, the perception of adolescents as lacking political power made politicians reluctant to act on the existing data on the severity of adolescent SRH. There was also a lack of consensus on the nature of interventions to be implemented. Pertaining to political contexts, sectoral funding by donors and government treasury brought about tension within the different government ministries resulting in siloed approaches, lack of coordination and overall inefficiency. However, the SRH community has several strengths that augur well for future political support. These include the diverse multi-sectoral background of its members, commitment to improving adolescent SRH, and the potential to link with other health priorities such as maternal health and HIV/AIDS. CONCLUSION: In order to increase political attention to adolescent SRH in Kenya, there is an urgent need for policy actors to: 1) create a more cohesive community of advocates across sectors, 2) develop a clearer public positioning of adolescent SRH, 3) agree on a set of precise approaches that will resonate with the political system, and 4) identify and nurture policy entrepreneurs to facilitate the coupling of adolescent SRH with potential solutions when windows of opportunity arise.

Correction: Adoption of routine virologic testing and predictors of virologic failure among HIV-infected children on antiretroviral treatment in western Kenya.

[This corrects the article DOI: 10.1371/journal.pone.0200242.].

Adoption of routine virologic testing and predictors of virologic failure among HIV-infected children on antiretroviral treatment in western Kenya.

BACKGROUND: Access to routine virologic monitoring, critical to ensuring treatment success, remains limited in low- and middle-income countries. We report on implementation of routine viral load (VL) monitoring and risk factors for virologic failure among HIV-infected children on antiretroviral treatment (ART) in Western Kenya. METHODS: Routine VL testing was introduced in western Kenya in November 2013. We performed a case-control study among 1190 HIV-infected children ≤15 years on ART who underwent routine VL testing June 2014-May 2015. A random sample of 98 cases (virologic failure define as VL >1000 cps/mL) and 201 controls (VL <1000 cps/mL) from five facilities in three high HIV prevalence counties in Kenya were followed for a minimum of 12 months. Data from patient charts were analyzed using logistic regression to determine factors associated with failure to attain virologic suppression at initial routine and subsequent VL testing among cases. RESULTS: Overall, 1190 (94%) children with a median age of 8 years underwent routine VL testing of whom (37%) had virological failure. Among the 299 cases and controls, WHO stage, baseline CD4 count and time since ART initiation were not associated with virologic failure during the follow-up period. In multivariable analysis, unsuppressed children at initial test were more likely to be male (adjusted Odds Ratio (aOR) 2.1, 95% Confidence Interval (CI) 2.1-3.6) and have had an ART regimen change (aOR 2.0, CI 1.0-3.7) than controls. Of the two-thirds of children 201/299 who had a subsequent VL performed, VL suppression was greater among those suppressed at initial test 126/135 (93.3%) compared to children with virologic failure 15/66 (22.7%, p<0.0001). Among those failing at first test who achieved viral suppression in follow up, 12/15 (80%) were on a protease inhibitor (PI)-based regimen. In the multivariable analysis of children with subsequent VL testing, children on PI-based 2nd line regimens were 10-fold more likely to achieve viral suppression than children on first-line NNRTI-based ART (adjusted Odds Ratio [aOR] 0.1; 95%CI 0.0-0.4). CONCLUSION: Coverage of initial routine viral load testing among children on ART in western Kenya is high. However, subsequent testing and virologic suppression are low in children with virologic failure on initial routine viral load test. There is an urgent need to improve management and viral load monitoring of children living with HIV experiencing treatment failure to ensure improved long-term outcomes.

Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection.

BACKGROUND: Recently, test developers have created rapid point-of-care tests that can simultaneously detect multiple infections within the same specimen using a single device. The SD BIOLINE Duo HIV/Syphilis rapid point-of-care test uses a solid-phase immunochromatographic assay to detect immunoglobulin (Ig)G, IgM, and IgA antibodies to human immunodeficiency virus (HIV)-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum. This study was a multisite laboratory-based evaluation of the performance of SD BIOLINE HIV/Syphilis Duo test using previously characterized sera in 6 countries. METHODS: Laboratories in Ghana, Mexico, Laos, Togo, Kenya, and Myanmar participated in the evaluation during 2012-2013. Each site characterized sera using T pallidum particle agglutination assay or T pallidum hemagglutination assay and HIV enzyme immunoassay, Western blot, and/or HIV antibody rapid tests. Those gold standard test results were compared with SD BIOLINE Duo test results. We calculated the sensitivity and specificity of test performance and used the exact binomial method to calculate 95% confidence intervals (CIs). RESULTS: The sensitivity and specificity for the HIV antibody test component (n = 2336) were estimated at 99.91% (95% CI, 99.51% and 100%) and 99.67% (95% CI, 99.16% and 99.91%), respectively. For the T pallidum test component (n = 2059), the sensitivity and specificity were estimated at 99.67% (95% CI, 98.82% and 99.96%) and 99.72% (95% CI, 99.29% and 99.92%), respectively. CONCLUSIONS: The sensitivity and specificity of the SD BIOLINE HIV/Syphilis Duo test were consistently high across sera specimens from 6 countries around the world. Dual rapid tests should be considered for improved HIV and syphilis screening coverage.