Cascade analysis of awareness, willingness, uptake and adherence with regard to PrEP among young men who have sex with men (YMSM) in China: A comparison between students and non-students.

INTRODUCTION: In China, young men who have sex with men (YMSM) are one of the groups most at risk of HIV/AIDS. The uptake of pre-exposure prophylaxis (PrEP) among YMSM has not been well documented. A cascade analysis of awareness, willingness, use and adherence with regard to PrEP was conducted separately among YMSM students and non-students. METHODS: From 20 October to 30 December 2021, all adolescents aged 16-24 years were selected for the study from among MSM recruited from 31 provincial administrative regions in mainland China. Participants were included in a cross-sectional study of awareness, willingness, use and adherence with regard to PrEP among YMSM. Logistic regression modelling was used to identify factors associated with the four outcomes. RESULTS: Among 1014 student and 866 non-student YMSMs, respectively, 88.07% and 81.64% had heard of PrEP; 58.16% and 50.35% were willing to use PrEP; 7.59% and 7.62% had used PrEP; and 3.16% and 3.58% had adhered to PrEP. Among students, those living in high-risk areas and pilot cities and those who had engaged in commercial sex and group sex had a positive effect on PrEP use, and the same trends were found among non-students living in high-risk areas and pilot cities and those who had engaged in group sex. 'Daily oral' and 'flexible' PrEP use positively influenced adherence among both groups. CONCLUSIONS: A differentiation strategy of PrEP promotion should be implemented among YMSM. Material support for students, such as financial resources, should increase, while non-students should increase their level of perception of HIV risk.

Intention and preference to use long-acting injectable PrEP among MSM in the Netherlands: a diffusion of innovation approach.

Long-acting injectable pre-exposure prophylaxis (LAI-PrEP) is efficacious in preventing HIV among men-who-have-sex-with-men (MSM) and will be soon available in Europe. This study investigated the intention and preference to use LAI-PrEP among MSM in the Netherlands by employing a diffusion of innovation approach. This study had a cross-sectional design nested within a cohort study established in 2017 to understand oral PrEP use among MSM. 309 MSM completed the survey on their awareness, interest, intention, and preference for LAI-PrEP in June 2022. Among them, 83% showed high/very-high interest in, and 63% showed high/very-high intention to use LAI-PrEP. A repeated innovator effect from the early adopters to LAI-PrEP was not observed. Early adopters did not show increased intention to use LAI-PrEP compared to other MSM subgroups, but neither did PrEP-naïve nor PrEP-discontinued MSM. However, among the 218 current oral PrEP users, suboptimal adherence was associated with preference for LAI-PrEP but not with intention to use it. In conclusion, our findings indicated that an effective, available, and affordable LAI-PrEP would be welcomed in the Netherlands, but that its introduction may not significantly expand PrEP coverage. However, the introduction of LAI-PrEP in the Netherlands could prove beneficial to MSM with suboptimal adherence to oral PrEP.

Factors Associated with PrEP Persistence and Loss of Follow-Up: A 5-Year Historic Cohort.

OBJECTIVE: HIV Pre-Exposure Prophylaxis (PrEP) has been used in France since 2016. Its effectiveness is no longer to be demonstrated. However, follow-up and adherence remain the main pitfalls. The main objective of this study was to identify factors associated with persistence or loss of PrEP follow-up. DESIGN: An historic cohort of PrEP users was compiled from the database of consultations in the Indre-et-Loire dedicated sexual health centers (CeGIDD) from June 2016 to June 2021. METHODS: Kaplan-Meier curves were performed to compare the group of persistent PrEP users to the discontinuation group. Factors associated with PrEP discontinuation were identified using Cox modelling, considering time-dependent variables. Final variables included in the model were selected based on the Akaike Information Criterion (AIC) and clinical relevance. RESULTS: Over the period, 568 PrEP users were included in the cohort. Median follow-up was 2.3 years. A quarter of users were lost to follow-up within 3 months after PrEP initiation. Sexual risk reduction AIDS community-based support (HR = 0.65[0.42;0.99]), being in a couple (HR = 0.51[0.38;0.68]), and history of syphilis (HR = 0.57[0.40;0.81]) were significantly associated with persistence of follow-up. Remote consultations (HR = 2.74[1.63;4.61]), chemsex practices (HR = 2.01[1.29;3.14]), and side effects (HR=1.72[1.03;2.88]) were significantly associated with a loss of follow-up. CONCLUSION: These results suggest that more sexual risk reduction AIDS community-based counseling could be a key, necessary for supporting PrEP users in their follow-up pathway. Indeed, AIDS community-based support could be used to build a basis for developing safe pathways. Remote consultations could represent a response to the issue of access to PrEP. To create a significant impact on global HIV incidence, the PrEP offer must be extended, and at-risk PrEP users supported to maintain PrEP use.

Challenges recruiting and retaining people at risk for HIV who use methamphetamine in a randomized PrEP adherence trial in Seattle, WA.

BACKGROUND: Methamphetamine is associated with increased HIV risk and suboptimal adherence to pre-exposure prophylaxis (PrEP). Interventions to support PrEP adherence for people who use methamphetamine are needed. METHODS: We evaluated peer navigation to support adherence among people initiating PrEP who use methamphetamine. The HIV Prevention in Methamphetamine Users (HMU!) study enrolled participants from May 2018-January 2022 in Seattle, WA, and followed them for 6 months. Surveys collected sociodemographic, drug use, and sexual behavior data at enrollment, month 3, and month 6. Dried blood spots (DBS) were collected at months 1, 3, and 6 to measure PrEP adherence. RESULTS: We enrolled 21 participants of a target sample of 40, of whom 20 were prescribed PrEP. Nine participants (43%) received peer navigation and 12 (57%) received standard of care or text messaging. At baseline, most participants reported at least weekly methamphetamine use (17, 81%) and condomless receptive anal intercourse (CRAI) (16, 76%). One-third reported CRAI with a partner with HIV. Among those who provided a DBS, 78% and 50% had results commensurate with ≥4 pills/week at the month 3 and 6 visit, respectively. More than half of those prescribed PrEP completed a month 6 visit (11, 55%). Retention was not associated with peer support compared to standard of care or text messaging (p = .20). CONCLUSIONS: We enrolled half our target sample size despite extensive recruitment efforts. As expected, participants had challenges with PrEP adherence and persistence. While peer navigation interventions should be studied further, additional interventions are likely needed to support PrEP uptake, adherence, and persistence among people who use methamphetamine.

Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial.

BACKGROUND: In Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators. METHODS: The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored. DISCUSSION: We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.

Adesão à profilaxia pré-exposição em homens que fazem sexo com homens (hsh) e mulheres transexuais em risco de contrair HIV

Introdução: Em uma epidemia concentrada, o HIV se espalha rapidamente em uma ou mais subpopulações específicas, com propagação relativamente modesta na população geral. Na América Latina, algumas populações-chave, como gays, bissexuais e outros homens que fazem sexo com homens (HSH), travestis e mulheres transgêneras (TrMT), são desproporcionalmente afetadas pelo HIV/aids, tendência que está se tornando mais forte nos últimos anos. A Profilaxia Pré-exposição (PrEP) se baseia no uso de medicamentos antirretrovirais (ARV) para a prevenção da aquisição do HIV. O uso diário da combinação oral de entricitabina e tenofovir disoproxil fumarato (FTC/TDF) é eficaz para PrEP, sendo disponível no Sistema Único de Saúde do Brasil (SUS) desde dezembro de 2017. Estudos demonstraram uma forte associação entre os níveis farmacológicos de FTC/TDF no plasma e no interior das células e da proteção contra a aquisição do HIV, atingindo 97-100% de proteção quando os níveis de adesão são alcançados. Objetivos: Descrever padrões e correlações da adesão à PrEP entre HSH e TrMT de um projeto demonstrativo (PrEP Brasil); avaliar efetividade de mensagens de texto (SMS) na adesão à PrEP; avaliar a adesão autorrelatada da PrEP e suas barreiras e facilitadores. Primeiro Artigo: Examinar a concordância entre três medidas de adesão indireta (taxa de posse de medicamento ou MPR, contagem de comprimidos e autorrelato) e níveis de medicamento altamente protetores medidos a partir de sangue coletado em papel de filtro (Dried Blood Spots - DBS) entre participantes retidos por 48 semanas no Estudo PrEP Brasil. Os níveis séricos de difosfato de tenofovir (TFV-DP) no DBS foram medidos na semana 48. Áreas sob a curva (AUC) foram usadas para avaliar a concordância entre alcançar níveis protetores de TFV-DP (700fmol/punch) e as medidas de adesão indireta. Os métodos de Youden Index e Distance to Cornerforam empregados para determinar os pontos de corte ideais para cada medida de adesão indireta. Sensibilidade, Especificidade e valores preditivos negativo (VPN) e positivo (VPP) foram calculados para cada ponto de corte encontrado. Finalmente, o teste de Delong foi usado para comparar as AUCs. Todas as medidas de adesão indireta foram capazes de discriminar entre participantes com e sem níveis protetores de TDF-DP (AUC> 0,5). Altos valores de adesão nas três medidas indiretas foram preditivos de níveis protetores (VPP> 0,8), enquanto baixos valores não foram preditivos para a falta de níveis protetores (VPN <0,5). Não foram encontradas diferenças significativas entre os métodos de adesão (p = 0,44). Segundo Artigo: Avaliar a eficácia do SMS em melhorar a adesão ao uso diário de FTC/TDF durante o estudo PrEP Brasil. Um sub-estudo piloto de SMS interativo foi oferecido a todos os participantes na visita de triagem. Os indivíduos que concordaram em participar foram randomizados 1: 1 para receber apenas o atendimento padrão (SoC), que incluiu aconselhamento de adesão, ou intervenção (SMS). Foram enviados SMS semanalmente aos participantes em um horário pré-determinado. A adesão adequada à PrEP foi definida como tendo MPR \2265 1,02, que foi o melhor ponto de corte para alcançar níveis protetores de TFV-DP nas semanas 4 e 48. Equações de Estimativas Generalizadas (GEE) foram utilizadas para acessar os fatores associados a adesão adequada à PrEP. Dos 450 participantes incluídos no PrEP Brasil, 417 (92.7%) foram randomizados no sub-estudo: 210 no braço SoC e 207 no braço SMS. Um total de 347 (83.2%) participantes completaram o estudo, e receber SMS não aumentou a retenção na semana 48. Uma maior proporção de participantes no grupo recebendo SMS apresentou adesão adequada à PrEP ao longo do estudo. Em análise multivariada, receber SMS foi preditor de adesão adequada à PrEP (AOR = 1,37; IC 95%: 1,07-1,75) quando ajustado por visita, localidade, idade sexo anal receptivo sem preservativo e uso de álcool. Terceiro Artigo: Avaliar a adesão autorrelatada à PrEP (recordatório de 30 dias) e as barreiras e facilitadores percebidos entre os retidos por 48 semanas no estudo da PrEP Brasil. A regressão logística foi utilizada para avaliar os preditores da adesão ótima (= 100%). A mediana de adesão nos últimos 30 dias foi de 100% (IQR: 92-100); 60,6% dos participantes (205/338) relataram adesão ótima. A maioria (82,2%; 278/338) dos participantes relatou não ter dificuldade em tomar FTC / TDF e 81,3% (274/338) relataram capacidade excelente ou muito boa. Barreiras e facilitadores percebidos foram relatados por 38,2% (129/338) e 98,5% (333/338), respectivamente; os principais facilitadores do uso da PrEP incluíram a associação com alguma atividade diária (59%), envolvimento com a PrEP (49%), manter os comprimidos em algum lugar visível e transportar a medicação com eles (45%), uso de alarme (39%) e medo de se infectar pelo HIV (38%). As principais barreiras para a PrEP incluíram a esquecimento de doses (50%), mudança na rotina diária (38%), falta de pílulas (25%) e ausência da pílula no momento da dose (12%). Dificuldades relatadas devido ao uso de drogas ou álcool, nenhum risco percebido, questões de privacidade ou efeitos colaterais foram incomuns (\2264 10%). Na análise multivariada, ser do Rio de Janeiro, TrMT, o uso de estimulantes e ter percepção de barreiras à PrEP foram associados à diminuição da chance de adesão ótima. Conclusões: Altos níveis de adesão mensurados por diferentes métodos indiretos (contagem de comprimidos, MPR e autorrelato) foram verificados na semana 48 e todos os métodos foram capazes de discriminar participantes que atingiram ou não níveis protetores de tenofovir. A intervenção por SMS foi eficaz para melhorar a adesão e a cobertura de PrEP ao longo do estudo, mas não teve impacto na retenção na semana 48. Nossos achados fornecem informações para elaboração, reforço e atualização de estratégias para melhorar a adesão, e para desenvolver as melhores práticas para promover a adesão à PrEP em nosso contexto.