Impact of HIV self-testing for oral pre-exposure prophylaxis scale-up on drug resistance and HIV outcomes in western Kenya: a modelling study.

BACKGROUND: Community-based oral pre-exposure prophylaxis (PrEP) provision has the potential to expand PrEP coverage. HIV self-testing can facilitate PrEP community-based delivery but might have lower sensitivity than facility-based HIV testing, potentially leading to inappropriate PrEP use among people with HIV and subsequent development of drug resistance. We aimed to evaluate the impact of HIV self-testing use for PrEP scale-up. METHODS: We parameterised an agent-based network model, EMOD-HIV, to simulate generic tenofovir disoproxil fumarate and emtricitabine PrEP scale-up in western Kenya using four testing scenarios: provider-administered nucleic acid testing, provider-administered rapid diagnostic tests detecting antibodies, blood-based HIV self-testing, or oral fluid HIV self-testing. Scenarios were compared with a no PrEP counterfactual. Individuals aged 18-49 years with one or more heterosexual partners who screened HIV-negative were eligible for PrEP. We assessed the cost and health impact of rapid PrEP scale-up with high coverage over 20 years, and the budget impact over 5 years, using various HIV testing modalities. FINDINGS: PrEP coverage of 29% was projected to avert approximately 54% of HIV infections and 17% of HIV-related deaths among adults aged 18-49 years over 20 years; health impacts were similar across HIV testing modalities used to deliver PrEP. The percentage of HIV infections with PrEP-associated nucleoside reverse transcriptase inhibitor (NRTI) drug resistance was 0·6% (95% uncertainty intervals 0·4-0·9) in the blood HIV self-testing scenario and 0·8% (0·6-1·0) in the oral HIV self-testing scenario, compared with 0·3% (0·2-0·3) in the antibody rapid diagnostic testing scenario and 0·2% (0·1-0·2) in the nucleic acid testing scenario. Accounting for background NRTI resistance, we found similarly low proportions of drug resistance across scenarios. The budget impact of implementing PrEP using HIV self-testing and provider-administered rapid diagnostic tests were similar, while nucleic acid testing was approximately 50% more costly. INTERPRETATION: Scaling up PrEP using HIV self-testing has similar health impacts, costs, and low risk of drug resistance as provider-administered rapid diagnostic tests. Policy makers should consider leveraging HIV self-testing to expand PrEP access among those at HIV risk. FUNDING: The Bill and Melinda Gates Foundation.

Legal and institutional foundations for universal health coverage, Kenya.

Kenya's Constitution of 2010 triggered a cascade of reforms across all sectors to align with new constitutional standards, including devolution and a comprehensive bill of rights. The constitution acts as a platform to advance health rights and to restructure policy, legal, institutional and regulatory frameworks towards reversing chronic gaps and improving health outcomes. These constitutionally mandated health reforms are complex. All parts of the health system are transforming concurrently, with several new laws enacted and public health bodies established. Implementing such complex change was hampered by inadequate tools and approaches. To gain a picture of the extent of the health reforms over the first 10 years of the constitution, we developed an adapted health-system framework, guided by World Health Organization concepts and definitions. We applied the framework to document the health laws and public bodies already enacted and currently in progress, and compared the extent of transformation before and after the 2010 Constitution. Our analysis revealed multiple structures (laws and implementing public bodies) formed across the health system, with many new stewardship structures aligned to devolution, but with fragmentation within the regulation sub-function. By deconstructing normative health-system functions, the framework enabled an all-inclusive mapping of various health-system attributes (functions, laws and implementing bodies). We believe our framework is a useful tool for countries who wish to develop and implement a conducive legal foundation for universal health coverage. Constitutional reform is a mobilizing force for large leaps in health institutional change, boosting two aspects of feasibility for change: stakeholder acceptance and authority to proceed.

Adoptée en 2010, la Constitution du Kenya a entraîné une série de réformes dans tous les secteurs afin de les adapter aux nouvelles normes constitutionnelles, notamment à la décentralisation et à une charte détaillée des droits. La Constitution sert de tremplin pour faire progresser les droits en matière de santé et restructurer les cadres politiques, juridiques, institutionnels et réglementaires en vue de réduire les disparités chroniques et d'améliorer les résultats cliniques. Toutefois, ces réformes de santé prévues dans la Constitution sont complexes. Toutes les composantes du système de santé évoluent en même temps, de nombreuses lois inédites sont promulguées et des organismes de santé publique sont créés. L'emploi d'approches et d'outils inadaptés a entravé la mise en œuvre de ces changements si complexes. Pour mieux appréhender l'étendue des réformes de santé entreprises au cours des 10 premières années de la Constitution, nous avons développé un cadre sanitaire sur mesure, inspiré des concepts et définitions de l'Organisation mondiale de la Santé. Nous avons appliqué ce cadre afin de récolter des données sur les organismes publics et les lois relatives à la santé qui ont d'ores et déjà été édictées ou sont en cours d'élaboration, et avons comparé l'ampleur des transformations avant et après la Constitution de 2010. Notre analyse a révélé de multiples structures (lois et organes publics de mise en œuvre) réparties dans l'ensemble du système de santé, avec plusieurs nouvelles structures de gestion conformes à la décentralisation mais une fragmentation au niveau de la sous-fonction de régulation. En décomposant les fonctions normatives du système de santé, le cadre a permis d'établir une cartographie globale des différentes caractéristiques de ce système (fonctions, lois et organes de mise en œuvre). Nous sommes convaincus que notre cadre représente un outil utile pour les pays qui souhaitent développer et instaurer des bases juridiques propices à la création d'une couverture maladie universelle. La réforme constitutionnelle possède un pouvoir de mobilisation capable de faire progresser le changement institutionnel dans le domaine de la santé. Et ce, en renforçant deux aspects qui favorisent sa réalisation: l'acceptation de la part des intervenants, et l'autorité nécessaire pour agir.

La Constitución de Kenia de 2010 generó una serie de reformas en todos los sectores para ajustarse a los nuevos estándares constitucionales, incluida la transmisión y una amplia carta de derechos. La constitución representa una plataforma para promover los derechos sobre la salud y reestructurar los marcos jurídicos, institucionales y normativos con el fin de revertir las deficiencias crónicas y mejorar los resultados de la salud. Estas reformas de la salud, establecidas por mandato constitucional, son complejas. Asimismo, todas las áreas del sistema de salud se están transformando de manera simultánea, ya que se han promulgado varias leyes nuevas y se han establecido organismos de salud pública. Sin embargo, la falta de herramientas y métodos adecuados limitó la implementación de estos cambios tan complejos. Se elaboró un marco adaptado del sistema sanitario, que se guía por los conceptos y las definiciones de la Organización Mundial de la Salud, para tener una idea del alcance de las reformas sanitarias en los primeros 10 años de la constitución. En este contexto, se aplicó el marco para documentar las leyes sanitarias y los organismos públicos ya promulgados y en curso, en el que se comparó el grado de transformación antes y después de la Constitución de 2010. El análisis realizado reveló que se habían formado múltiples estructuras (leyes y organismos públicos de ejecución) en todo el sistema sanitario, que tenían muchas estructuras de gestión nuevas alineadas con la transmisión, pero que estaban fragmentadas dentro de la subfunción de reglamentación. Al desestructurar las funciones normativas del sistema sanitario, el marco permitió realizar un mapeo completo de los diversos atributos del sistema sanitario (funciones, leyes y organismos de ejecución). Se considera que el marco que se propone aquí es un instrumento útil para los países que quieren elaborar e implementar un fundamento jurídico propicio para la cobertura sanitaria universal. La reforma constitucional es una fuerza de movilización que permite obtener importantes avances en el cambio institucional del sector sanitario, lo que fomenta dos aspectos de la viabilidad del cambio: la aceptación de las partes interesadas y la autoridad para proceder.

Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya.

INTRODUCTION: Since 2011, Kenya has been evaluating ShangRing device for use in its voluntary medical male circumcision (VMMC) program according to World Health Organization (WHO) guidelines. Compared to conventional surgical circumcision, the ShangRing procedure is shorter, does not require suturing and gives better cosmetic outcomes. After a pilot evaluation of ShangRing in 2011, Kenya conducted an active surveillance for adverse events associated with its use from 2016-2018 to further assess its safety, uptake and to identify any operational bottlenecks to its widespread use based on data from a larger pool of procedures in routine health care settings. METHODS: From December 2017 to August 2018, HIV-negative VMMC clients aged 13 years or older seeking VMMC at six sites across five counties in Kenya were offered ShangRing under injectable local anesthetic as an alternative to conventional surgical circumcision. Providers described both procedures to clients before letting them make a choice. Outcome measures recorded for clients who chose ShangRing included the proportions who were clinically eligible, had successful device placement, experienced adverse events (AEs), or failed to return for device removal. Clients failing to return for follow up were sought through phone calls, text messages or home visits to ensure removal and complete information on adverse events. RESULTS: Out of 3,692 eligible clients 1,079 (29.2%) chose ShangRing; of these, 11 (1.0%) were excluded due to ongoing clinical conditions, 17 (1.6%) underwent conventional surgery due to lack of appropriate device size at the time of the procedure, 97.3% (1051/1079) had ShangRing placement. Uptake of ShangRing varied from 11% to 97% across different sites. There was one severe AE, a failed ShangRing placement (0.1%) managed by conventional wound suturing, plus two moderate AEs (0.2%), post removal wound dehiscence and bleeding, that resolved without sequelae. The overall AE rate was 0.3%. All clients returned for device removal from fifth to eleventh day after placement. CONCLUSION: ShangRing circumcision is effective and safe in the Kenyan context but its uptake varies widely in different settings. It should be rolled out under programmatic implementation for eligible males to take advantage of its unique benefits and the freedom of choice beyond conventional surgical MMC. Public education on its availability and unique advantages is necessary to optimize its uptake and to actualize the benefit of its inclusion in VMMC programs.