Rapid antiretroviral therapy and treatment outcomes among people living with HIV: exploring the mediating roles of medication adherence.

Introduction: The rapid initiation of antiretroviral therapy (ART) and its impact on treatment outcomes have been a subject of global public health interest. However, the precise mechanisms underlying the effects of rapid ART initiation remain unclear. Methods: This retrospective cohort study examined data from 1846 HIV-infected individuals in Jiulongpo District, Chongqing, China, spanning from 2016 to 2022. Logistic regression models and serial mediation analysis were used to explore the influence of rapid ART initiation on treatment outcomes and the role of medication adherence as a mediating factor. Results: The findings revealed a significant association between rapid ART initiation and reduced risk of viral failure (adjusted odds ratio [OR] = 0.320, 95% confidence interval [CI] = [0.161, 0.637]), as well as an increased likelihood of improved adherence (adjusted OR = 2.053, 95% CI = [1.226, 3.438]). Medication adherence was identified as a partial mediator in the relationship between rapid ART initiation and viral failure, explaining 10.5% of the total effect. Discussion: In conclusion,rapid initiation of antiretroviral therapy was found to enhance treatment outcomes, emphasizing the importance of early adherence education. The study recommends early initiation of ART coupled with adherence education and psychological counseling for HIV-infected individuals.

Reconciling advantages and difficulties: knowledge and perceptions of event-driven PrEP among young people. / Conciliando vantagens e dificuldades: conhecimentos e percepções da PrEP sob demanda entre jovens.

OBJECTIVE: This study aims to analyze the knowledge about the HIV event-driven pre-exposure prophylaxis (event-driven PrEP) scheme and the perception of its potential use among young men who have sex with men (MSM), travestis, and transgender women (TrTW) who were followed up in the cohort. METHODS: This qualitative study included 50 interviews with participants from the municipalities of Salvador and São Paulo, aged 15 to 19 years, who made daily use of PrEP or other preventive methods. They were addressed by different demand creation strategies. The in-depth interviews covered topics such as sexual practices, event-driven PrEP knowledge, acceptability, and motivations for its use. A two-stage thematic analysis was carried out on Nvivo, version 12. RESULTS: Most participants were unaware of event-driven PrEP, and many questioned its effectiveness and safety when receiving information about it. However, on learning about the program, many young people saw advantages, such as not having to take daily medication and the possibility of using it only at times of greater risk. Participants also found barriers to using event-driven PrEP, such as the unpredictability of sexual relations and the difficulty in administering dosages in this modality. CONCLUSION: Limited knowledge and experiences with daily oral PrEP influenced interest in event-driven PrEP, which highlights the need for information strategies that enable young MSM and TrTW to read about event-driven PrEP. Young people valued the autonomy and management of preventive methods provides by this new modality, which is more in line with the dynamics of their sexual lives, but they face challenges in managing event-driven PrEP.

OBJETIVO: O objetivo deste estudo é analisar o conhecimento sobre o esquema de Profilaxia Pré-Exposição ao HIV sob demanda (PrEP-SD) e a percepção do seu uso potencial entre jovens homens que fazem sexo com homens (HSH), travestis e mulheres trans (TrMT) em acompanhamento na coorte. MÉTODOS: O estudo qualitativo incluiu 50 entrevistas com participantes das cidades de Salvador e São Paulo, entre 15 e 19 anos, que estavam usando PrEP diária ou outros métodos preventivos. Eles foram abordados por meio de diferentes estratégias de criação de demanda. As entrevistas em profundidade abordaram temas como práticas sexuais, conhecimento sobre PrEP-SD, aceitabilidade e motivações para o uso. Foi realizada análise temática em duas fases usando o software Nvivo versão 12. RESULTADOS: A maioria dos participantes desconhecia a PrEP-SD e muitos questionaram a sua efetividade e segurança ao receberem informações sobre ela. No entanto, ao conhecer o esquema, muitos jovens perceberam vantagens, como a não obrigatoriedade diária de medicamentos e a possibilidade de uso apenas em momentos de maior risco. Barreiras para o uso da PrEP-SD também foram identificadas pelos participantes, como a imprevisibilidade das relações sexuais e a dificuldade em administrar as dosagens nessa modalidade. CONCLUSÕES: O conhecimento limitado e as experiências com a PrEP oral diária influenciaram o interesse por ela, o que aponta a necessidade de estratégias informativas que permitam o letramento dos jovens HSH e TrMT na PrEP-SD. Os jovens valorizaram a autonomia e a gestão da prevenção mais alinhada à dinâmica de sua vida sexual propiciada pela nova modalidade, mas enfrentam desafios na gestão da PrEP-SD.

Perceptions and practices of healthcare providers in providing HIV pre-exposure prophylaxis to trans adolescents and young adults and men who have sex with men. / Percepções e práticas de profissionais de saúde na oferta da profilaxia pré-exposição sexual ao HIV para adolescentes e jovens trans e homens que fazem sexo com homens.

OBJECTIVE: This study aims to understand the perceptions and practices of healthcare providers regarding the offer of HIV pre-exposure prophylaxis (PrEP) to gay and trans adolescents and young adults. METHODS: This qualitative research was developed as part of the PrEP1519 study, which was conducted from 2018 to 2021 to analyze the effectiveness of PrEP in adolescents and young adults. Data were collected from July 2020 to February 2021 at the municipality of São Paulo by combining participant observations and semi-structured interviews. The analytical process involved immersion in the empirical material and coding and categorizing it with the support of NVivo®. Interpretation followed the hermeneutic-dialectical principle and had the concept of Care in health practices as its horizon. RESULTS: The construction of trust-based relationships followed practices that acknowledge the uniqueness of youth and their demands and sought to strengthen their autonomy. Sensitive and supportive listening was pointed out as a welcoming practice that propelled care actions. Welcoming attitudes and support in facing stigma and violence (related or not to the use of PrEP) acknowledged the need to support adolescents and young adults to develop autonomy for prevention. The use of language close to young people's everyday life favored the construction of relationships of trust and positively influenced the development of autonomy and adherence to PrEP. The tension between technical and practical success occurred in the idealized search for adult-centric normativity as opposed to intersubjectivity. CONCLUSION: The perceptions and practices of healthcare providers are aligned with the concept of Care as they include actions beyond technical knowledge and recognize the contexts that increase the vulnerability of adolescents and young adults to HIV.

OBJETIVO: Compreender as percepções e práticas de profissionais de saúde no contexto da oferta de profilaxia pré-exposição ao HIV (PrEP) entre adolescentes e jovens gays e trans. MÉTODOS: Trata-se de pesquisa qualitativa desenvolvida como parte do estudo PrEP1519, realizada entre 2018 e 2021, com o objetivo de analisar a efetividade de PrEP entre adolescentes e jovens. Os dados foram produzidos de julho de 2020 a fevereiro de 2021 no sítio de São Paulo, combinando técnicas de observação-participante e entrevistas semiestruturadas. O processo analítico envolveu imersão no material empírico, codificação e categorização, com apoio do software NVivo®. A interpretação seguiu o princípio hermenêutico-dialético e teve como horizonte o conceito de cuidado inserido nas práticas de saúde. RESULTADOS: A construção do vínculo de confiança foi informada por práticas que reconheciam a singularidade dos/as adolescentes/jovens e suas demandas e buscavam impulsionar sua autonomia. A escuta sensível e solidária foi apontada como uma prática de acolhimento propulsora de ações de cuidado. Atitudes acolhedoras e suporte frente a situações de estigma e violências, relacionadas ou não ao uso de PrEP, convergiram para o reconhecimento da necessidade de apoio no desenvolvimento de autonomia para a prevenção entre adolescentes e jovens. O uso de linguagem próxima do cotidiano favoreceu a construção de relações de confiança, influenciando positivamente o desenvolvimento da autonomia e a adesão a PrEP. A tensão entre êxito técnico e sucesso prático foi observada na busca idealizada pela normatividade adultocêntrica em contraposição à intersubjetividade. CONCLUSÃO: As percepções e práticas dos/as profissionais de saúde se mostram coerentes com o conceito de cuidado, pois compreendem ações além dos saberes técnicos e reconhecem os contextos que aumentam a vulnerabilidade dos/as adolescentes e jovens ao HIV.

Risk and pleasure in the era of pharmacologically safe sex. / Risco e prazer em tempos de sexo farmacologicamente seguro.

OBJECTIVE: This article discusses how Pre-Exposure Prophylaxis (PrEP) and the undetectable viral load=untransmissible (UVL=U) have produced reconfigurations in the contexts of affective-sexual encounters of young gay men/men who have sex with men (MSM) living with HIV (YLHIV). METHODS: In-depth interviews were conducted with nine YLHIV, aged 18 to 29, from two studies conducted in Salvador, Bahia, in 2019 and 2021. The narratives focused on unprecedented events in the prevention and treatment of HIV/AIDS, which have allowed experiences of greater intimacy and safety but also challenges and tensions in affective-sexual relationships. RESULTS: Different moments in the experience of living with HIV reveal different narratives of YLHIV concerning the new PrEP and UVL biotechnologies. Concerns surrounding possible HIV transmission or the obligation to reveal serology are more prominent among young people with the most recent diagnosis. In contrast, those with more extended serology experience are more comfortable and confident in the face of new technologies and their significant effects on sexual encounters. However, controversies remain regarding the moral and behavioral consequences of their use. Some YLHIV re-update concerns and bring reports about the continuity of stigma toward people living with HIV. Others emphasize the benefits of biomedical advances, opening up new interactive possibilities, including without the use of condoms, highlighting the existence of other practices, knowledge, dynamics, and ways of negotiating risk/care, with tensions in the field of sexuality itself. CONCLUSIONS: We reiterate the need to resume public policies in the field of HIV/AIDS beyond biomedical strategies, highlighting vulnerabilities, the dissemination of information about new HIV prevention and treatment technologies, respect for people's autonomy in their preventive choices, and the development of strategies to combat the stigma associated with HIV/AIDS.

OBJETIVO: Neste artigo, discutimos como a profilaxia pré-exposição (PrEP) e a carga viral indetectável=intransmissível (CVI=I) têm produzido reconfigurações nos contextos de encontros afetivo-sexuais de jovens gays/ homens que fazem sexo com homens (HSH) vivendo com HIV (JVHIV). MÉTODOS: Conduzimos entrevistas em profundidade com nove JVHIV, de 18 a 29 anos, oriundos de duas pesquisas realizadas em Salvador/Bahia, em 2019 e 2021. Focalizamos narrativas sobre acontecimentos inéditos na prevenção e no tratamento do HIV/aids, que têm permitido experiências de maior intimidade e segurança, mas também desafios e tensionamentos às relações afetivo-sexuais. RESULTADOS: Momentos distintos da experiência de viver com HIV revelam diferentes narrativas dos JVHIV com relação às novas biotecnologias de PrEP e CVI. Preocupações em torno de uma possível transmissão do HIV ou da obrigação de revelar a sorologia ficam mais destacadas entre jovens com o diagnóstico mais recente, enquanto aqueles com maior tempo de sorologia se colocam de forma mais confortável e confiante frente às novas tecnologias e seus efeitos significativos nos encontros sexuais, ainda que permaneçam controvérsias a respeito das consequências morais e comportamentais do uso delas. Alguns JVHIV reatualizam preocupações e trazem relatos sobre a continuidade do estigma em relação às pessoas vivendo com HIV. Outros JVHIV enfatizam os benefícios dos avanços biomédicos, com abertura para novas possibilidades interativas, inclusive sem uso da camisinha, sublinhando a existência de outras práticas, saberes, dinâmicas e formas de negociação do risco/cuidado, com tensionamentos no campo da própria sexualidade. CONCLUSÕES: Reiteramos a necessidade de retomada de políticas públicas no campo do HIV/aids para além das estratégias biomédicas, dando destaque às vulnerabilidades, à disseminação de informações sobre as novas tecnologias de prevenção e tratamento do HIV, ao respeito à autonomia das pessoas em suas escolhas preventivas e ao desenvolvimento de estratégias de enfrentamento aos estigmas associados ao HIV/aids.

Prep provision in community organizations: a comparative study with conventional services. / Oferta de prep em organizações comunitárias: estudo comparativo com serviços convencionais.

OBJECTIVE: To evaluate whether adolescents from sexual minorities who initiated pre-exposure prophylaxis (PrEP) in community-based organizations (COs) are more socially and HIV-vulnerable compared with their counterparts from a conventional health service. In addition, to evaluate whether these adolescents had more timely access to prophylaxis. METHODS: A PrEP demonstration study was conducted in the city of São Paulo in two COs, located in the center (CO-center) and the outskirts (CO-outskirts), and a conventional HIV testing service (CTA-center). Between 2020 and 2022, cisgender male adolescents who have sex with men (aMSM), transgender and gender diverse adolescents (aTTrans) aged 15 to 19 years, HIV-negative, with higher-risk practices for HIV were eligible for PrEP. Indicators of timely access and vulnerabilities of adolescents initiating PrEP in COs were analyzed using CTA-center as a reference and multinomial logistic regression. RESULTS: 608 adolescents initiated PrEP in COs and CTA-center. Adolescents from COs were associated with a shorter time to PrEP initiation (1-7 days; CO-outskirts: ORa = 2.91; 95%CI 1.22-6.92; CO-center: ORa = 1.91; 95%CI 1.10-3.31); and a lower housing Human Development Index (HDI) (CO-center: ORa = 0.97; 95%CI 0.94-1.00; CO-outskirts: ORa = 0.82; 95%CI 0.78-0.86). In CO-outskirts, there was an increased chance of adolescents being younger (ORa = 3.06; 95%CI 1.63-5.75) and living closer to the service (ORa = 0.82; 95%CI 0.78-0.86, mean 7.8 km). While adolescents from the CO-center were associated with greater prior knowledge of PrEP (ORa = 2.01; 95%CI 1.10-3.91) and high-risk perception (ORa = 2.02; 95%CI 1.18-3.44), adolescents from the COs were not associated with higher-risk sexual practices and situations of vulnerability to HIV. CONCLUSION: The provision of PrEP in the COs facilitated access for vulnerable adolescents and may contribute to reducing inequities.

OBJETIVO: Avaliar se adolescentes de minorias sexuais que iniciaram a profilaxia pré-exposição sexual (PrEP) em organizações comunitárias (OC) apresentam maior vulnerabilidade social e ao HIV em comparação com adolescentes em PrEP de um serviço de saúde convencional. Além disso, avaliar se esses adolescentes tiveram um acesso mais oportuno à profilaxia. MÉTODOS: Estudo demonstrativo da efetividade de PrEP, realizado na cidade de São Paulo, em duas OC, localizadas no centro (OC-centro) e na periferia (OC-periferia), e em um serviço convencional de testagem para o HIV (CTA-centro). Foram elegíveis para PrEP, entre 2020 e 2022, adolescentes homens cisgêneros que fazem sexo com homens (aHSH), travestis, mulheres transexuais e pessoas transfemininas (aTTrans), de 15 a 19 anos, HIV-negativos e com práticas de maior risco para o HIV. Indicadores de acesso oportuno e de vulnerabilidades dos adolescentes iniciando PrEP nas OC foram analisados, tendo por referência o CTA-centro e empregando regressão logística multinomial. RESULTADOS: 608 adolescentes iniciaram PrEP nas OC e CTA-Centro. Adolescentes das OC estiveram associados a um menor tempo de início de PrEP (1­7 dias; OC-periferia: ORa = 2,91; IC95% 1,22­6,92; OC-centro: ORa = 1,91; IC95% 1,10­3,31); e a um menor IDH de moradia (OC-centro: ORa = 0,97; IC95% 0,94­1,00; OC-periferia: ORa = 0,82; IC95% 0,78­0,86). Na OC-periferia houve aumento na chance de os adolescentes serem mais jovens (ORa = 3,06; IC95% 1,63­5,75) e morarem mais próximos ao serviço (ORa = 0,82; IC95% 0,78­0,86, média 7,8 km). Enquanto adolescentes da OC-centro estiveram associados ao maior conhecimento prévio de PrEP (ORa = 2,01; IC95% 1,10­3,91) e a alta percepção de risco (ORa = 2,02; IC95% 1,18­3,44). Não estiveram associadas aos adolescentes das OC as práticas sexuais de maior risco e as situações de vulnerabilidade ao HIV. CONCLUSÕES: A oferta de PrEP nas OC facilitou o acesso de adolescentes vulnerabilizados e pode contribuir para reduzir inequidades.

Development of a pharmacy-based HIV PrEP service delivery intervention for Washington, District of Columbia (DC): A study protocol.

Pharmacy-based PrEP service delivery models can help address many of the barriers that inhibit the uptake of PrEP. In an increasing number of states, legislation has been passed, or is under consideration, to allow pharmacists to initiate PrEP without a prescription from a physician or other prescriber. However, there is not yet legislation in Washington, DC to allow pharmacy-based PrEP despite its potential to curb new cases of HIV, which disproportionately affect the Black community in the area. The DC Ends HIV Plan has a goal of less than 130 new cases of HIV per year by 2030, which would require that over 13,000 high-risk residents use PrEP. However, in 2021 only 6,724 Washingtonians were taking PrEP. This study seeks to address the absence of critical formative research into the factors that would influence the implementation of pharmacy-based PrEP in Washington DC using the Implementation Mapping (IM) framework. A needs assessment will be conducted through in-depth interviews (IDIs) with pharmacists (n = 6), PrEP providers (n = 6), current PrEP users (n = 6), DC Department of Health officials (n = 2), DC Board of Pharmacy officials (n = 4) and pharmacy-based PrEP experts (n = 4) to provide input on the operational aspects of pharmacy-based PrEP model as a strategy to increase PrEP uptake. Information gathered through this needs assessment will be used to develop standard operating procedures for the introduction of pilot pharmacy-based PrEP into community-based retail pharmacies.

A gut check: understanding the interplay of the gastrointestinal microbiome and the developing immune system towards the goal of pediatric HIV remission.

Despite the efficacy of antiretroviral therapy (ART) in reducing the global incidence of vertical HIV transmissions, more than 120,000 children are still infected with the virus each year. Since ART cannot clear the HIV reservoir that is established soon after infection, children living with HIV (CLWH) are forced to rely on therapy for their lives and suffer from long-term drug-related complications. Pediatric HIV infection, like adult infection, is associated with gut microbial dysbiosis, loss of gut epithelial integrity, bacterial translocation, CD4 + T cell depletion, systemic immune activation, and viral reservoir establishment. However, unlike in adults, HIV that is vertically acquired by infants interacts with a gut microbiome that is continuously evolving while concomitantly shaping the infant's immune ontogeny. Therefore, to determine whether there may be interventions that target the HIV reservoir through microbiome-directed approaches, understanding the complex tripartite interactions between the transmitted HIV, the maturing gut microbiome, and the developing immune system during early life is crucial. Importantly, early life is the time when the gut microbiome of an individual is highly dynamic, and this temporal development of the gut microbiome plays a crucial role in educating the maturing immune system of a child. Therefore, manipulation of the gut microbiome of CLWH to a phenotype that can reduce HIV persistence by fostering an antiviral immune system might be an opportune strategy to achieve ART-free viral suppression in CLWH. This review summarizes the current state of knowledge on the vertical transmission of HIV, the developing gut microbiome of CLWH, and the immune landscape of pediatric elite controllers, and explores the prospect of employing microbial modulation as a potential therapeutic approach to achieve ART-free viral suppression in the pediatric population.

Transmitted drug resistance and molecular transmission network among treatment-naive HIV-1 patients in Wenzhou, China, 2020-2023.

BACKGROUND: Transmitted drug resistance (TDR) increases the risk of antiretroviral therapy (ART) failure in HIV-1 patients. This study investigated the molecular epidemiology of TDR and its transmission networks among newly diagnosed HIV-1 patients in Wenzhou, China. METHODS: We enrolled 1878 ART-naive HIV-1 patients from January 2020 to October 2023. TDR was evaluated using the Stanford University HIV Drug Resistance Database. We performed phylogenetic analysis, genotyping, transmission clustering, and population-based TDR-related factor analysis. RESULTS: Among 1782 patients with successful genotyping, TDR prevalence was 5.7%. Multivariable analysis identified CRF08_BC subtype (adjusted odds ratio [aOR] 18.59, 95% CI 3.79-336.18, p = 0.004), CD4 > 500 cells/mm³ (aOR 2.19, 95% CI 1.16-4.03, p = 0.013), and year 2023 (aOR 1.83, 95% CI 1.11-4.89, p = 0.039) as factors associated with higher TDR risk. The most prevalent NNRTI mutations were K103N, E138A, and V179E. Seven TDR transmission clusters were identified, notably one with V179D that expanded during 2020-2023. CONCLUSIONS: While TDR prevalence in Wenzhou remained lower than in other Chinese regions, an upward trend was observed. Most resistant individuals were in transmission clusters, predominantly middle-aged and elderly. NNRTI resistance was severe and concentrated in efavirenz, nevirapine, and rilpivirine. Enhanced HIV surveillance and wider free antiretroviral options are crucial to control drug-resistant HIV spread in Wenzhou.

Sweden surpasses the UNAIDS 95-95-95 target: estimating HIV-1 incidence, 2003 to 2022.

BackgroundSweden reached the UNAIDS 90-90-90 target in 2015. It is important to reassess the HIV epidemiological situation due to ever-changing migration patterns, the roll-out of PrEP and the impact of the COVID-19 pandemic.AimWe aimed to assess the progress towards the UNAIDS 95-95-95 targets in Sweden by estimating the proportion of undiagnosed people with HIV (PWHIV) and HIV incidence trends.MethodsWe used routine laboratory data to inform a biomarker model of time since infection. When available, we used previous negative test dates, arrival dates for PWHIV from abroad and transmission modes to inform our incidence model. We also used data collected from the Swedish InfCareHIV register on antiretroviral therapy (ART).ResultsThe yearly incidence of HIV in Sweden decreased after 2014. In part, this was because the fraction of undiagnosed PWHIV had decreased almost twofold since 2006. After 2015, three of four PWHIV in Sweden were diagnosed within 1.9 and 3.2 years after infection among men who have sex with men and in heterosexual groups, respectively. While 80% of new PWHIV in Sweden acquired HIV before immigration, they make up 50% of the current PWHIV in Sweden. By 2022, 96% of all PWHIV in Sweden had been diagnosed, and 99% of them were on ART, with 98% virally suppressed.ConclusionsBy 2022, about half of all PWHIV in Sweden acquired HIV abroad. Using our new biomarker model, we assess that Sweden has reached the UNAIDS goal at 96-99-98.

An observational cohort study evaluating PrEP reach, engagement and persistence through a community-based mobile clinic in Miami-Dade County, Florida.

INTRODUCTION: Barriers to pre-exposure prophylaxis (PrEP) access have limited its reach to priority populations. Community-based mobile clinics have potential to broaden PrEP engagement. We evaluated reach and persistence for fixed and mobile clinic cohorts in Miami-Dade County, Florida. METHODS: This observational cohort study analysed data from 1896 clients engaged through our fixed or mobile clinic from August 2018 to March 2023. Services were offered at no cost to clients. The same staff and package of barrier-lowering strategies was deployed across fixed and mobile clinic sites. Chi-square and Fisher's exact test or the Kruskal-Wallis test were used to test for differences in characteristics across sites as well as across services sought. Kaplan-Meier curves were generated to evaluate persistence on PrEP and in care, defined as completion of at least one clinic visit (including PrEP prescribing, for PrEP persistence, or for any reason, for persistence in care) within 24 weeks of the prior visit. Cox proportional hazards models were used to evaluate risk factors for discontinuation of PrEP or clinic care by 48 weeks by gender, race, ethnicity, insurance status and site. RESULTS: The fixed and mobile clinics reached 781 and 1109 clients, respectively, during the study period. The median client age was 35 years; the majority (70.4%) of clients were cisgender men, identified as Hispanic/Latino (62.5%) and were men who have sex with men (54.5%). The mobile clinic extended reach to a higher proportion of cisgender women (32.1% mobile vs. 12.9% for fixed clinic), Black clients (34.5% vs. 13.1%) and older clients (median 37 vs. 33 years) compared with the fixed setting. Uninsured individuals, men and those who initiated services in the mobile clinic were more likely to continue PrEP to 48 weeks (HR: 1.20, p = 0.01; HR: 2.02, p<0.01; HR: 1.68, p<0.01, respectively). Persistence did not differ by race or ethnicity. CONCLUSIONS: A mobile clinic strategy for PrEP engagement can increase reach to key populations underrepresented in HIV prevention care including cisgender women and Black clients. Persistence in PrEP was increased for the mobile clinic cohort, suggesting an additional benefit to this modality beyond other barrier-lowering strategies employed in our fixed and mobile clinics.

A Systematic Review and Meta-analysis of the Impact of the COVID-19 Pandemic on Access to HIV Pre-exposure Prophylaxis: Lessons for Future Public Health Crises.

BACKGROUND: The World Health Organization is committed to strengthening access to pre-exposure prophylaxis (PrEP) for HIV prevention and its integration into primary care services. Unfortunately, the COVID-19 pandemic has disrupted the delivery of primary care, including HIV-related services. To determine the extent of this disruption, we conducted a systematic review and meta-analysis of the changes in access to PrEP services during the pandemic and the reasons for these changes. METHODS: A search was conducted using PubMed, Scopus, Embase, PsycINFO, and Cinahl for studies published between January 2020 and January 2023. Selected articles described self-reported disruptions to PrEP service access associated with the COVID-19 pandemic or its responses. Pooled effect sizes were computed using a random-effects model. RESULTS: Thirteen studies involving 12,652 PrEP users were included in our analysis. The proportion of participants reporting a disruption in access to PrEP services during the COVID-19 pandemic ranged from 3% to 56%, with a pooled proportion of 21% (95% confidence intervals: 8% to 38%). Social restrictions, financial constraints, and limited health insurance coverage were key factors affecting access to PrEP services during the pandemic. CONCLUSIONS: To our knowledge, this is the first meta-analysis to quantify the extent of disruptions to accessing PrEP services because of the COVID-19 pandemic. To increase the ability of primary care services to maintain PrEP services during public health crises, a mixture of strategies is worth considering. These include multi-month PrEP prescriptions, telehealth services, deployment of peer support groups to provide a community-based service or home delivery, and provision of financial support interventions.

Three Novel Patient-Reported Outcome Measures to Assess the Patient Experience With Daily and Weekly HIV Oral Antiretroviral Therapy.

BACKGROUND: Patient-reported outcome measures (PROMs) can provide data on the barriers and facilitators of adherence to daily oral antiretroviral therapy (OART) regimens. We aimed to develop PROMs to understand the perspectives of people with HIV (PWH) on (1) facilitators/barriers to daily OART regimen adherence and (2) a hypothetical switch to a long-acting (LA)-OART regimen. METHODS: Following the US food and drug administration patient-reported outcome guidance, targeted literature reviews and concept elicitation interviews with clinicians (n = 7) and PWH (n = 28) were conducted to develop conceptual models (CMs) of facilitators/barriers to OART regimen adherence. Three de novo PROMs were developed after an item-generation meeting. Three waves of cognitive debriefing interviews were conducted among PWH (n = 30) to demonstrate content validity and refine the PROMs. RESULTS: The targeted literature review identified 25 facilitators/barriers; an additional 16 facilitators/barriers were added by clinicians and PWH and represented in 2 CMs. During the item-generation meeting, the CMs were used to develop 3 de novo PROMs: (1) HIV Patient Perspective of Regimen, (2) HIV Patient Perspective of Regimen Change, and (3) HIV Drivers of Adherence Questionnaire. In the cognitive debriefing interviews, PWH corroborated the relevancy of items in the PROMs, and minor adjustments were made for clarity. CONCLUSION: Three content-valid PROMs were developed to understand the treatment experience of PWH taking daily OART and how that experience may be altered upon a switch to weekly LA-OART. Data from future LA-OART clinical trials will help define a scoring guide and evaluate the structure and measurement properties of the PROMs.

High efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Black adults in the United States, including those with pre-existing HIV resistance and suboptimal adherence.

BRAAVE (NCT03631732), a Phase 3b, multicenter, open-label US study, demonstrated the efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) among Black individuals with suppressed HIV through 48 weeks. Here, 72-week resistance, adherence, and virologic outcomes are presented. Enrollment criteria permitted nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistance (R), protease inhibitor (PI)-R, and certain nucleos(t)ide reverse transcriptase inhibitor (NRTI)-R (M184V/I allowed; ≥3 thymidine analog mutations [TAMs] excluded); but excluded primary integrase strand transfer inhibitor (INSTI)-R. Pre-existing resistance was determined using historical genotypes and retrospective baseline proviral DNA genotyping. Adherence, virologic outcomes, and viral blips were assessed. Of 489 participants receiving B/F/TAF with ≥1 post-switch HIV-1 RNA measurement: pre-existing NRTI-R (15% of participants), M184V/I (11%), ≥1 TAMs (8%), NNRTI-R (22%), and PI-R (13%) were observed; pre-existing INSTI-R substitutions (2%) were detected post-randomization; mean viral blip frequency was 0.9% across all timepoints (unassociated with virologic failure); 24% of participants had <95% adherence (98% of whom had HIV-1 RNA <50 copies/mL at last visit); none had treatment-emergent study-drug resistance. Overall, 99% of participants, including all with baseline NRTI-R/INSTI-R, had HIV-1 RNA <50 copies/mL at the last visit, demonstrating that B/F/TAF maintained virologic suppression through 72 weeks regardless of pre-existing resistance, viral blips, and suboptimal adherence.

Experience of the national cohort of pregnant women with HIV and their children in Spain: temporal trends in vertical transmission of HIV and associated infections.

INTRODUCTION: The vertical transmission rate (VTR) of HIV has decreased to less than 2% in high-income countries, in spite of which perinatal infections continue to occur. We present data from the national cohort of pregnant women living with HIV and their children in Spain. The objectives were to describe the characteristics of this population, evaluate the VTR of HIV, the safety of antiretroviral therapy (ART) and the prevalence of coinfection. PATIENTS AND METHODS: Multicentre prospective, observational and descriptive study with participation of 62 hospitals. The sample included pegnant women living with HIV whose children were born between January 2020 and December 2022. We collected prospective data on the characteristics of mothers and children using an online questionnaire (REDCap web application). RESULTS: The study included 414 mother-child dyads. Most mothers were immigrants (227/349; 65.1%). The main route of HIV infection was heterosexual transmission (160/402; 39.8%), followed by vertical transmission (44/402; 10.9%). The diagnosis was made before conception in 313/389 women (80.4%), 394/402 (98%) received ART during pregnancy and 356/402 (89.3%) had an undetectable viral load at the time of delivery. The delivery was vaginal in 230/388 children (59.3%). The proportion of preterm birth was 11.1%. The most frequent neonatal prophylaxis approach was monotherapy with zidovudine (358/414; 86.5%). There were 3 cases of vertical transmission of HIV (95% CI, 0%-1.54%). Only one newborn was breastfed. CONCLUSIONS: At present, most women living with HIV in Spain receive the diagnosis before conception, are of foreign ancestry and achieve good control of the infection. Although the VTR is very low in Spain, there are still infections that could be prevented with early diagnosis and treatment.

Using stated preference methods to design gender-affirming long-acting PrEP programs for transgender and nonbinary adults.

Integrating gender-affirming care with biomedical HIV prevention could help address the disproportionate HIV risk experienced by transgender and nonbinary (trans) adults. This discrete choice experiment assesses and identifies the most important programming factors influencing the decisions of trans adults to use injectable long-acting HIV pre-exposure prophylaxes (LA-PrEP). From March to April 2023 n = 366 trans adults in Washington state chose between four different choice profiles that presented hypothetical programs (each comprised of 5 attributes with 4 levels). We analyzed ranked choice responses using a mixed rank-ordered logit model for main effects. Respondents preferred to receive LA-PrEP from a gender-affirming care provider and a co-prescription for both oral and injectable hormones. Trans adults strongly favored 12-month protection and injection in the upper arm. No strong preferences emerged surrounding the type of health facility offering the gender-affirming LA-PrEP program. Our findings show that integrating and leveraging gender-affirming health systems, inclusive of medical services such as hormone therapy, with HIV biomedical products like LA-PrEP is strongly preferred and influential to trans adults' decision to use LA-PrEP. Leveraging choice-based design experiments provides informative results for optimizing gender-affirming LA-PrEP programming tailored to trans adults.

Preferences for pre-exposure prophylaxis delivery via online pharmacy among potential users in Kenya: a discrete choice experiment.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is highly effective, but coverage remains low in high HIV prevalence settings. Initiating and continuing PrEP remotely via online pharmacies is a promising strategy to expand PrEP uptake, but little is known about potential users' preferences. METHODS: We conducted a discrete choice experiment (DCE) to assess preferences for online pharmacy PrEP services. We partnered with MYDAWA, an online pharmacy in Nairobi, Kenya. Eligibility criteria were: ≥18 years, not known HIV positive, interested in PrEP. The DCE contained four attributes: PrEP eligibility assessment (online self-assessed, guided), HIV test type (provider administered, oral HIV self-test [HIVST], blood-based HIVST), clinical consultation (remote, in-person) and user support options (text messages, phone/video call, email). Additionally, participants indicated whether they were willing to uptake their selected service. The survey was advertised on MYDAWA's website; interested participants met staff in-person at a convenient location to complete the survey from 1 June to 20 November 2022. We used conditional logit modelling with an interaction by current PrEP use to estimate overall preferences and latent class analysis (LCA) to assess preference heterogeneity. RESULTS: Overall, 772 participants completed the DCE; the mean age was 25 years and 54% were female. Most participants indicated a willingness to acquire online PrEP services, with particularly high demand among PrEP-naive individuals. Overall, participants preferred remote clinical consultation, HIV self-testing, online self-assessment and phone call user support. The LCA identified three subgroups: the "prefer online PrEP with remote components" group (60.3% of the sample) whose preferences aligned with the main analysis, the "prefer online PrEP with in-person components" group (20.7%), who preferred in-person consultation, provider-administered HIV testing, and guided assessment, and the "prefer remote PrEP (18.9%)" group who preferred online PrEP services only if they were remote. CONCLUSIONS: Online pharmacy PrEP is highly acceptable and may expand PrEP coverage to those interested in PrEP but not accessing services. Most participants valued privacy and autonomy, preferring HIVST and remote provider interactions. However, when needing support for questions regarding PrEP, participants preferred phone/SMS contact with a provider. One-fifth of participants preferred online PrEP with in-person components, suggesting that providing multiple options can increase uptake.

"Someone who hates themself doesn't come for their drugs": Experiences of mental health along the HIV care continuum in South-Central, Uganda.

INTRODUCTION: Poor mental health occurs more frequently among people living with HIV. Understanding what mental health problems occur and at what point during the continuum of HIV care is critical to ensure these problems are identified and appropriately addressed. We explored how mental health is experienced along the HIV care continuum in Rakai, Uganda. METHODS: We conducted qualitative semi-structured in-depth interviews with 20 adults living with HIV and 10 health workers from March to December 2020. Interviews followed a timeline approach. Responses were analyzed using content analysis. RESULTS: At the time of HIV diagnosis, nearly all participants described a range of strong emotions, including shock, fear and intense worry. Most participants described continued fear and intense worry leading up to, and at the time of, ART initiation. However, they said these emotions often subside after ART is initiated and viral suppression is achieved. Across interviews and at multiple points of the continuum, participants discussed how fear and worry led individuals to be "thinking too much" or be in "deep thoughts" and experience self-hatred. Individuals who stopped taking ART were thought to have more severe mental health problems ("madness", psychosis, suicidality). Participants were divided about the mental health of persons who returned to care after disengagement. CONCLUSION: In this setting, mental health problems experienced by people living with HIV are dynamic across the care continuum. With expanded HIV testing campaigns and Universal Test and Treat policies, targeted interventions for psychosocial support at the time of testing and ART initiation remain critical.