Telehealth effectiveness for pre-exposure prophylaxis delivery in Brazilian public services: the Combine! Study.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) delivery based on user needs can enhance PrEP access and impact. We examined whether telehealth for daily oral PrEP delivery could change the indicators of care related to prophylactic use in five Brazilian public HIV clinics (testing centres, outpatient clinics and infectious disease hospitals). METHODS: Between July 2019 and December 2020, clients on PrEP for at least 6 months could transition to telehealth or stay with in-person follow-up. Clients were clinically monitored until June 2021. A desktop or mobile application was developed, comprising three asynchronous consultations and one annual in-person consultation visit. Predictors influencing telehealth preference and care outcomes were examined. The analysis encompassed intent-to-treat (first choice) and adjustments for sexual practices, schooling, age, duration of PrEP use and PrEP status during the choice period. RESULTS: Of 470 users, 52% chose telehealth, with the adjusted odds ratio (aOR) increasing over time for PrEP use (aOR for 25-months of use: 4.90; 95% CI: 1.32-18.25), having discontinued PrEP at the time of the choice (aOR: 2.91; 95% CI: 1.40-6.06) and having health insurance (aOR: 1.91; 95% CI: 1.24-2.94) and decreasing for those who reported higher-risk behaviour (aOR for unprotected anal sex: 0.51; 95% CI: 0.29-0.88). After an average follow-up period of 1.6 years (95% CI: 1.5-1.7), the risk of discontinuing PrEP (not having the medication for more than 90 days) was 34% lower with telehealth (adjusted hazard ratio: 0.66; 95% CI: 0.45-0.97). When adjusted by mixed linear regression, no differences in adherence (measured by mean medication possession rate) were found between in-person and telehealth (p = 0.486) or at pre- and post-telehealth follow-ups (p = 0.245). Sexually transmitted infections increased between the pre-follow-up and post-follow-up choices and were not associated with in-person or telehealth (p = 0.528). No HIV infections were observed. CONCLUSIONS: Our findings indicate that telehealth for PrEP delivery can enhance service rationalization and reinforce the prevention cascade. This approach reduces prophylaxis interruptions and is mainly preferred by individuals with lower demands for healthcare services.

Acceptability of teleconsultation in a public service specialized in the prevention and care of HIV infection and other sexually transmitted infections / Aceitabilidade da teleconsulta em um serviço público especializado na prevenção e cuidado da infecção pelo HIV e outras infecções sexualmente transmissíveis

Introduction: Telemedicine was leveraged for its contribution to mitigate the impact of COVID-19 in Brazil and worldwide. Objective: We aim to evaluate the acceptability of incorporating teleconsultation through synchronized videoconference by users and professionals in a service specialized in the prevention and treatment of the human immunodeficiency virus and other sexually transmitted infections, and to identify associated factors. Methods: This is a cross-sectional study with 410 users and 57 professionals who answered a category-standardized questionnaire. Predictors of acceptability were assessed using logistic regression model. Results: A total of 364 (88.8%) users said they would accept the modality. The factors positively associated with the odds of acceptance were the self-assessment of having favorable conditions to participate in a teleconsultation (aOR 54.8; 95%CI 12.4­242.1; p<0.001), the perception of saving money (aOR 5.2; 95%CI 1.9­14.0; p=0.001), and perceived convenience of the modality (aOR 6.7; 95%CI 2.9­15.9; p<0.001). Factors associated with reduced odds of acceptance were the fear of not being evaluated well (aOR 0.2; 95%CI 0.1­0.4; p<0.001), or remaining long without seeing the professional (aOR 0.2; 95%CI 0.1­0.5; p<0.001). The acceptance of the modality among professionals was 75.4% and the perception of its convenience (aOR 16.8; 95%CI 2.6­108.4; p=0.003) and that the institution has appropriated conditions (aOR 7.7; 95%CI 1.5­40.6; p=0.016) were associated with increased odds of accepting its incorporation in their routine. Conclusion: Governance should invest in infrastructure and support, secure protocols, digital literacy, and training of its users and employees for video teleconsultation. (AU)

Introdução: A telemedicina foi alavancada por sua contribuição para mitigar o impacto da COVID-19 no Brasil e no mundo. Objetivo: Pretendemos avaliar a aceitabilidade da incorporação da teleconsulta por videoconferência síncrona por usuários e profissionais de um serviço especializado na prevenção e tratamento da infecção pelo vírus da imunodeficiência humana (HIV) e outras infecções sexualmente transmissíveis, bem como identificar fatores associados. Métodos: Estudo transversal com 410 usuários e 57 profissionais, que responderam a um questionário padronizado por categoria. Os preditores de aceitabilidade foram avaliados utilizando-se um modelo de regressão logística. Resultados: O total de 364 (88,8%) usuários disseram que aceitariam a modalidade. Os fatores positivamente associados à probabilidade de aceitação foram a autoavaliação quanto a ter condições favoráveis para participar de uma teleconsulta (razão de chances ajustada ­ aOR 54,8; intervalo de confiança de 95% ­ IC95% 12,4­242,1; p<0,001), a percepção de poupar dinheiro (aOR 5,2; IC95% 1,9­14,0; p=0,001) e a percepção de conveniência da modalidade (aOR 6,7; IC95% 2,9­15,9; p<0,001). As menores probabilidades de aceitação foram o medo de não ser bem avaliado (aOR 0,2; IC95% 0,1­0,4; p<0,001) e de permanecer muito tempo sem ver o profissional (aOR 0,2; IC95% 0,1­0,5; p<0,001). A aceitação da modalidade pelos profissionais foi de 75,4% e a percepção de sua conveniência (aOR 16,8; IC95% 2,6­108,4; p=0,003) e a de que a instituição possui condições favoráveis (aOR 7,7; IC95% 1,5­40,6; p=0,016) foram associadas com a maior probabilidade de aceitar a incorporação da modalidade em sua rotina. Conclusão: A governança deve investir em infraestrutura e apoio, protocolos seguros, literacia digital e treinamento de seus usuários e funcionários para a videoconsulta. (AU)

[From evidence to action: challenges for the Brazilian Unified National Health System in offering pre-exposure prophylaxis (PrEP) for HIV to persons with the greatest vulnerability]. / Da evidência à ação: desafios do Sistema Único de Saúde para ofertar a profilaxia pré-exposição sexual (PrEP) ao HIV às pessoas em maior vulnerabilidade.

Pre-exposure prophylaxis (PrEP) has been considered a promising strategy for controlling the global HIV epidemic. However, it is necessary to translate the knowledge accumulated from clinical trials and demosntration studies to the reality of health services and the groups most vulnerable to infection in order to achieve broad coverage with PrEP. The article proposes a reflection on this challenge, focusing on three dimensions: users of prophylaxis, with an emphasis on the contexts of sexual practices and the potential exposures to HIV; the advantages of prophylaxis as compared to other methods and the challenges for protective and safe use; and health services, considering the organizational principles to ensure greater success in the supply and incorporation of PrEP as part of combination prevention strategies. The following principles were analyzed: uniqueness of care, freedom of choice and non-hierarchization of prevention methods, sexual risk management, scheduling flexibility, and complementary and multidisciplinary care. These principles can foster organization of the health service and care, facilitating linkage and retention in care. Some comments were offered on the relative incompatibility between the existing structure of services and the Brazilian Ministry of Health guidelines for offering PrEP. The conclusion was that the success of PrEP as a public health policy depends on two essential factors: ensuring that health services are culturally diverse settings, free of discrimination, and the intensification of community-based interventions, including social networks, in order to reduce inequalities in access to PrEP and health services as a whole.

A profilaxia pré-exposição sexual (PrEP) tem sido considerada estratégica e promissora no controle da epidemia de HIV globalmente. Contudo, faz-se necessário transpor o conhecimento acumulado pelos estudos de eficácia e demonstrativos à realidade dos serviços e das populações mais vulneráveis à infecção, de forma a alcançar uma ampla cobertura da PrEP. Propõe-se uma reflexão sobre tal desafio enfocando duas dimensões: os usuários da profilaxia, com ênfase nos contextos de práticas e de potencial exposição ao HIV; as vantagens comparativas da profilaxia em relação aos demais métodos e os desafios para um uso protetivo e seguro; e os serviços, considerando os princípios organizativos que poderão conferir maior êxito na oferta e na incorporação da PrEP, no bojo das estratégias de prevenção combinada. Foram analisados como alguns princípios - singularidade no cuidado, autonomia para escolha e não hierarquização dos métodos, gestão de risco sexual e flexibilidade de agendamento e complementaridade de uma equipe multiprofissional - podem favorecer a organização do serviço e do cuidado, facilitando a vinculação e retenção dos usuários. Teceram-se algumas considerações acerca de uma relativa incompatibilidade entre a estrutura existente nos serviços e as diretrizes do Ministério da Saúde para oferta de PrEP. Concluiu-se que o maior êxito da PrEP como política pública de saúde depende de dois aspectos centrais: assegurar que os serviços sejam ambientes culturalmente diversos e livres de discriminação e a intensificação das intervenções comunitárias, incluindo as redes sociais, de forma a reduzir iniquidades no acesso aos serviços e à PrEP.

La profilaxis pre-exposición sexual (PrEP) ha sido considerada una estratégica y prometedora acción en el control de la epidemia de VIH globalmente. No obstante, se hace necesario trasladar el conocimiento acumulado por los estudios de eficacia, que muestren la realidad de los servicios y la población más vulnerable a la infección, de manera que se alcance una amplia cobertura de la PrEP. Se propone una reflexión sobre este desafío centrándose en dos dimensiones: usuarios de profilaxis, con énfasis en contextos de prácticas y potencial exposición al VIH; ventajas comparativas de la profilaxis, respecto a los demás métodos, y los desafíos para un uso con protección y seguro; y los servicios, considerando principios organizativos que podrían otorgar un mayor éxito a la oferta e incorporación de la PrEP, en el seno de estrategias de prevención combinada. Se analizaron como algunos principios: singularidad en el cuidado, autonomía para la elección y no jerarquización de los métodos, gestión del riesgo sexual y flexibilidad de citas y complementariedad de un equipo multiprofesional. Todos ellos pueden favorecer la organización del servicio y del cuidado, facilitando la vinculación y preservación de los usuarios. Se elaboraron algunas consideraciones, acerca de una relativa incompatibilidad entre la estructura existente en los servicios y las directrices del Ministerio de Salud de Brasil para la oferta de PrEP. Se concluyó que el mayor éxito de la PrEP, como política pública de salud, depende de dos aspectos centrales: asegurar que los servicios sean ambientes culturalmente diversos y libres de discriminación y la intensificación de las intervenciones comunitarias, incluyendo redes sociales, de forma que se reduzcan las inequidades en el acceso a los servicios y al PrEP.

Da evidência à ação: desafios do Sistema Único de Saúde para ofertar a profilaxia pré-exposição sexual (PrEP) ao HIV às pessoas em maior vulnerabilidade / From evidence to action: challenges for the Brazilian Unified National Health System in offering pre-exposure prophylaxis (PrEP) for HIV to persons with the greatest vulnerability / De la evidencia a la acción: desafíos del Sistema Único de Salud para ofrecer la profilaxis pre-exposición sexual (PrEP) al VIH a personas con mayor vulnerabilidad

Resumo: A profilaxia pré-exposição sexual (PrEP) tem sido considerada estratégica e promissora no controle da epidemia de HIV globalmente. Contudo, faz-se necessário transpor o conhecimento acumulado pelos estudos de eficácia e demonstrativos à realidade dos serviços e das populações mais vulneráveis à infecção, de forma a alcançar uma ampla cobertura da PrEP. Propõe-se uma reflexão sobre tal desafio enfocando duas dimensões: os usuários da profilaxia, com ênfase nos contextos de práticas e de potencial exposição ao HIV; as vantagens comparativas da profilaxia em relação aos demais métodos e os desafios para um uso protetivo e seguro; e os serviços, considerando os princípios organizativos que poderão conferir maior êxito na oferta e na incorporação da PrEP, no bojo das estratégias de prevenção combinada. Foram analisados como alguns princípios - singularidade no cuidado, autonomia para escolha e não hierarquização dos métodos, gestão de risco sexual e flexibilidade de agendamento e complementaridade de uma equipe multiprofissional - podem favorecer a organização do serviço e do cuidado, facilitando a vinculação e retenção dos usuários. Teceram-se algumas considerações acerca de uma relativa incompatibilidade entre a estrutura existente nos serviços e as diretrizes do Ministério da Saúde para oferta de PrEP. Concluiu-se que o maior êxito da PrEP como política pública de saúde depende de dois aspectos centrais: assegurar que os serviços sejam ambientes culturalmente diversos e livres de discriminação e a intensificação das intervenções comunitárias, incluindo as redes sociais, de forma a reduzir iniquidades no acesso aos serviços e à PrEP.

Abstract: Pre-exposure prophylaxis (PrEP) has been considered a promising strategy for controlling the global HIV epidemic. However, it is necessary to translate the knowledge accumulated from clinical trials and demosntration studies to the reality of health services and the groups most vulnerable to infection in order to achieve broad coverage with PrEP. The article proposes a reflection on this challenge, focusing on three dimensions: users of prophylaxis, with an emphasis on the contexts of sexual practices and the potential exposures to HIV; the advantages of prophylaxis as compared to other methods and the challenges for protective and safe use; and health services, considering the organizational principles to ensure greater success in the supply and incorporation of PrEP as part of combination prevention strategies. The following principles were analyzed: uniqueness of care, freedom of choice and non-hierarchization of prevention methods, sexual risk management, scheduling flexibility, and complementary and multidisciplinary care. These principles can foster organization of the health service and care, facilitating linkage and retention in care. Some comments were offered on the relative incompatibility between the existing structure of services and the Brazilian Ministry of Health guidelines for offering PrEP. The conclusion was that the success of PrEP as a public health policy depends on two essential factors: ensuring that health services are culturally diverse settings, free of discrimination, and the intensification of community-based interventions, including social networks, in order to reduce inequalities in access to PrEP and health services as a whole.

Resumen: La profilaxis pre-exposición sexual (PrEP) ha sido considerada una estratégica y prometedora acción en el control de la epidemia de VIH globalmente. No obstante, se hace necesario trasladar el conocimiento acumulado por los estudios de eficacia, que muestren la realidad de los servicios y la población más vulnerable a la infección, de manera que se alcance una amplia cobertura de la PrEP. Se propone una reflexión sobre este desafío centrándose en dos dimensiones: usuarios de profilaxis, con énfasis en contextos de prácticas y potencial exposición al VIH; ventajas comparativas de la profilaxis, respecto a los demás métodos, y los desafíos para un uso con protección y seguro; y los servicios, considerando principios organizativos que podrían otorgar un mayor éxito a la oferta e incorporación de la PrEP, en el seno de estrategias de prevención combinada. Se analizaron como algunos principios: singularidad en el cuidado, autonomía para la elección y no jerarquización de los métodos, gestión del riesgo sexual y flexibilidad de citas y complementariedad de un equipo multiprofesional. Todos ellos pueden favorecer la organización del servicio y del cuidado, facilitando la vinculación y preservación de los usuarios. Se elaboraron algunas consideraciones, acerca de una relativa incompatibilidad entre la estructura existente en los servicios y las directrices del Ministerio de Salud de Brasil para la oferta de PrEP. Se concluyó que el mayor éxito de la PrEP, como política pública de salud, depende de dos aspectos centrales: asegurar que los servicios sean ambientes culturalmente diversos y libres de discriminación y la intensificación de las intervenciones comunitarias, incluyendo redes sociales, de forma que se reduzcan las inequidades en el acceso a los servicios y al PrEP.

Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil.

INTRODUCTION: Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods. METHODS AND ANALYSIS: A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group-individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group-individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV. ETHICS AND DISSEMINATION: This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals and meetings.

Virologic and immunologic effectiveness at 48 weeks of darunavir-ritonavir-based regimens in treatment-experienced persons living with HIV-1 infection in clinical practice: a multicenter Brazilian cohort.

INTRODUCTION: Published data addressing the effectiveness of darunavir-ritonavir (DRV/r)-based therapy for multiexperienced patients in developing countries are scarce. This study evaluated the 48-week virologic and immunologic effectiveness of salvage therapy based on DRV/r for the treatment of multidrug-experienced HIV-1-infected adults in Brazil. MATERIALS AND METHODS: A multicenter retrospective cohort study was carried out with multidrug-experienced adults who were on a failing antiretroviral therapy and started a DRV/r-based salvage therapy between 2008 and 2010. The primary effectiveness end point was the proportion of patients with virologic success (plasma HIV-1 RNA <50 copies/mL at week 48). RESULTS: At 48 weeks, 73% of the patients had HIV-RNA <50 copies/mL and a mean increase of 108 CD4 cells/mm(3). Higher baseline viral load, lower baseline CD4 count, younger age, and 3 or more DRV/r-associated resistance mutations were significantly predictive of virologic failure. Concomitant use of raltegravir was strongly associated with virologic success. CONCLUSION: The use of DRV/r-based regimens for salvage therapy is an effective strategy in the clinical care setting of a developing country.