Preparing for the Implementation of Long-Acting Injectable Cabotegravir for HIV Pre-Exposure Prophylaxis Within the Brazilian Public Health System (ImPrEP CAB Brasil): Qualitative Study.

BACKGROUND: Although long-acting, injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention in clinical trials, research is needed to guide effective implementation in real-world settings. Formative work with community members and health care providers (HCPs) is important to provide insight into the needs and contexts of specific populations and reveal potential barriers and facilitators for implementation projects. OBJECTIVE: We aimed to describe the results from formative work to develop an implementation package for CAB-LA PrEP within the ImPrEP CAB Brasil study. METHODS: ImPrEP CAB Brasil is an implementation study of same-day delivery of CAB-LA PrEP for young sexual and gender minority (SGM) groups (aged 18-30 years) in 6 existing oral PrEP public health clinics. We conducted formative research to prepare for the implementation of ImPrEP CAB Brasil through community mobilization, process mapping with HCPs with experience in CAB-LA, and focus group discussions (FGDs) with young SGM groups (n=92) and HCPs (n=20) to identify initial perceptions of facilitators and barriers for CAB-LA PrEP implementation, refine the mobile health (mHealth) educational tool, and evaluate the acceptability of using a text message appointment reminder intervention through WhatsApp. FGDs were recorded, transcribed, systematically coded, and analyzed with thematic categorization by trained researchers using a qualitative data analysis program ATLAS.ti (version 7). RESULTS: A community mobilization team comprising 34 SGM community leaders collaborated in creating a prototype for an mHealth educational tool and contributed to the planning of peer education activities. We created 3 process maps for each site to describe the initial visit, follow-up visits, and laboratory flow. The main challenge identified for same-day CAB-LA PrEP delivery was the extended duration of clinic visits due to the numerous laboratory tests and HIV counseling steps required. Proposed solutions included having point-of-care HIV rapid tests instead of laboratory tests and additional counseling staff. Barriers for CAB-LA PrEP implementation identified through FGDs were the training of HCPs, support for adherence to injection appointments, and stigma or discrimination against SGM groups and persons using PrEP. The mHealth educational tool and WhatsApp reminders were highly acceptable by SGM groups and HCPs, indicating their potential to support PrEP choice and adherence. Content analysis on the cultural appropriateness of the language and overall clarity of the material contributed to the refinement of the mHealth tool. CONCLUSIONS: Structured formative work with SGM persons and HCPs generated important refinements to context-specific materials and plans to launch ImPrEP CAB Brasil in public health clinics. Ongoing implementation monitoring will use the process maps to identify additional barriers and potential solutions to same-day delivery of CAB-LA PrEP. Summative evaluations are needed to measure the effectiveness of the mHealth educational tool to support PrEP choice and the use of WhatsApp appointment reminders.

Bacterial sexually transmitted infections among men who have sex with men and transgender women using oral pre-exposure prophylaxis in Latin America (ImPrEP): a secondary analysis of a prospective, open-label, multicentre study.

BACKGROUND: The global burden of sexually transmitted infections (STIs) poses a challenge in the context of HIV pre-exposure prophylaxis (PrEP) programmes. We aimed to explore factors associated with prevalent, incident, and recurrent STIs in men who have sex with men (MSM) and transgender women on PrEP in Brazil, Mexico, and Peru. METHODS: ImPrEP was a prospective, single-arm, open-label, multicentre study that enrolled MSM and transgender women in the context of the public health systems of Brazil (14 sites), Mexico (four sites), and Peru (ten sites) between February, 2018, and June, 2021. Eligibility criteria followed regional PrEP guidelines at the study start, including participants aged 18 years and older, not living with HIV, and reporting at least one of the following in the previous 6 months: condomless anal sex (CAS), anal sex with partner(s) living with HIV, any bacterial STI, or transactional sex. Eligible participants were screened and enrolled on the same day to receive daily oral PrEP (tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg). We assessed three outcomes: prevalent bacterial STIs, incident bacterial STIs, and recurrent bacterial STIs. Testing occurred at baseline and quarterly for syphilis, anorectal chlamydia, and anorectal gonorrhoea. Behavioural data were collected at baseline and quarterly. The study was registered with the Brazilian Registry of Clinical Trials, U1111-1217-6021. FINDINGS: Among all 9509 participants included in the ImPrEP study (3928 [41·3%] in Brazil, 3288 [34·6%] in Mexico, and 2293 [24·1%] in Peru), 8525 (89·7%) had available STI results at baseline and were included in the prevalent STI analysis, and 7558 (79·5%) had available STI results during follow-up and were included in the incident and recurrent STI analyses. 2184 (25·6%) of 8525 participants had any bacterial STI at baseline. STI incidence during follow-up was 31·7 cases per 100 person-years (95% CI 30·7-32·7), with the highest rate for anorectal chlamydia (11·6 cases per 100 person-years, 95% CI 11·0-12·2), followed by syphilis (10·5 cases per 100 person-years, 9·9-11·1) and anorectal gonorrhoea (9·7 cases per 100 person-years, 9·2-10·3). Although only 2391 (31·6%) of 7558 participants had at least one STI during follow-up, 915 (12·1%) participants had recurrent diagnoses, representing 2328 (61·2%) of 3804 incident STI diagnoses. Characteristics associated with prevalent, incident, and recurrent STIs included younger age, multiple sex partners, receptive CAS, substance use, and previous STI diagnoses at baseline (incident or recurrent only). INTERPRETATION: Our findings underscore the nuanced dynamics of STI transmission among MSM and transgender women across Latin America, highlighting an urgent need for tailored interventions to mitigate STI burden effectively, especially among the most susceptible individuals. FUNDING: Unitaid, WHO, and ministries of health (Brazil, Mexico, and Peru). TRANSLATIONS: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.

Exploring the Resurgence of a Neglected Disease: Lessons From the 2023-2024 Mpox Outbreak in Rio de Janeiro, Brazil.

Following the 2022 global mpox outbreak, diagnoses decreased worldwide, even in settings with limited vaccine access. In 2023-2024, a new outbreak emerged in Rio de Janeiro, Brazil, highlighting the importance of continuous surveillance, preventive measures such as vaccination in vulnerable populations, and treatment options, emphasizing equitable global health technology distribution.

Brazilian Version of the Health Care Provider HIV/AIDS Stigma Scale: Cross-Cultural Adaptation and Psychometric Evaluation Among Healthcare Students.

We aimed to validate the Health Care Provider HIV/AIDS Stigma Scale (HPASS) among healthcare students in Brazil. The validation process occurred in three phases from August 2022 to July 2023: translation and cross-cultural adaptation; content validity assessment involving four experts; and evaluation of psychometric properties among 553 healthcare students from the Federal University of Espírito Santo. We used exploratory factor analysis and convergent validity for structural validation. The average scale content validity index was 0.90, while the evaluation of validity evidence based on the internal structure indicated a robust explanatory model. Parallel analysis indicated that the scale is composed by two dimensions: "Discrimination/Prejudice" and "Stereotype"; the composite reliability values for these dimensions were 0.96 and 0.85, respectively. The Brazilian version of HPASS has shown to be a simple, reliable, and psychometrically valid measure to quantify HIV stigma among healthcare students who speak Brazilian Portuguese.Resumen El objetivo de este estudio fue validar la "Health Care Provider HIV/AIDS Stigma Scale" (HPASS) entre estudiantes de salud en Brasil. El proceso de validación se llevó a cabo en tres etapas: traducción y adaptación transcultural; evaluación de la validez de contenido; y evaluación de las propiedades psicométricas con estudiantes de salud de la Universidad Federal de Espírito Santo. El índice de validez de contenido promedio de la escala fue de 0.90, mientras que la evaluación de la evidencia de validez basada en la estructura interna indicó un modelo explicativo sólido. El análisis paralelo indicó que la escala está compuesta por dos dimensiones: "Discriminación/Prejuicio" y "Estereotipo". La versión brasileña de HPASS ha demostrado ser una medida simple, confiable y psicométricamente válida para cuantificar el estigma del VIH entre estudiantes de salud que hablan portugués brasileño.

Evaluation of Mpox Knowledge, Stigma, and Willingness to Vaccinate for Mpox: Cross-Sectional Web-Based Survey Among Sexual and Gender Minorities.

BACKGROUND: The 2022 multicountry mpox outbreak positioned the condition as a public health emergency of international concern. By May 2023, Brazil ranked second globally in the cumulative number of mpox cases and deaths. The higher incidence of mpox among gay and other men who have sex with men in the current mpox outbreak deepens the stigma and discrimination against sexual and gender minorities (SGM). This might worsen the structural barriers impacting access to health services, which ultimately leads to undertesting and underreporting of cases. There are no data available on mpox knowledge and stigma in Latin America. OBJECTIVE: We aimed to evaluate mpox knowledge, stigma, and willingness to vaccinate for mpox among SGM, and to describe sociodemographic and behavioral characteristics according to self-reported mpox diagnosis. METHODS: A cross-sectional, internet-based survey was conducted in a convenience sample of adults (aged >18 years) living in Brazil recruited through advertisements on dating apps, social media, referral institutions for infectious diseases websites, and mass media (October-November 2022). We compared participants' characteristics according to self-reported mpox diagnosis using chi-square test or Fisher exact test for qualitative variables and Kruskal-Wallis test for quantitative variables. RESULTS: We enrolled 6236 participants: 5685 (91.2%) were cisgender men; 6032 (96.7%) were gay, bisexual, or pansexual; 3877 (62.2%) were White; 4902 (78.7%) had tertiary education; and 4070 (65.2%) reported low or middle income. Most participants (n=5258, 84.4%) agreed or strongly agreed that "LGBTQIA+ individuals are being discriminated and stigmatized due to mpox." Mpox awareness was 96.9% (n=6044), and 5008 (95.1%) were willing to get vaccinated for mpox. Overall, 324 (5.2%) reported an mpox diagnosis. Among these, 318 (98.1%) reported lesions, 178 (56%) local pain, and 316 (99.4%) sought health care. Among participants not reporting a diagnosis, 288 (4.9%) had a suspicious lesion, but only 158 (54.9%) of these had sought health care. Compared to participants with no diagnosis, those reporting an mpox diagnosis were younger (P<.001), reported more sex partners (P<.001), and changes in sexual behavior after mpox onset (P=.002). Moreover, participants diagnosed with mpox reported more frequently being tested for HIV in the prior 3 months (P<.001), living with HIV (P<.001), currently using HIV pre-exposure prophylaxis (P<.001), and previous sexually transmitted infection diagnosis (P<.001). CONCLUSIONS: Our results point to high mpox knowledge and willingness to vaccinate among SGM in Brazil. Participants self-reporting mpox diagnosis more frequently reported to be living with HIV, STI diagnosis, and current pre-exposure prophylaxis use, highlighting the importance of an mpox assessment that includes comprehensive sexual health screenings. Efforts to decrease stigma related to mpox among SGM are necessary to avoid mpox underdiagnosis.

Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study.

BACKGROUND: Long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs). OBJECTIVE: ImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services. METHODS: This type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively. RESULTS: During the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023. CONCLUSIONS: ImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South. TRIAL REGISTRATION: Clinicaltrials.gov NCT05515770; https://clinicaltrials.gov/ct2/show/NCT05515770. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44961.

Preferences for pre-exposure prophylaxis (PrEP) among sexual and gender minorities: a discrete choice experiment in Brazil.

Background: Men who have sex with men (MSM) and transgender women (TGW) are disproportionally affected by HIV infection in Latin America. This study aims to assess pre-exposure prophylaxis (PrEP) preferences among sexual and gender minorities (SGM) and identify attributes and levels that are related to PrEP uptake and adherence, both crucial for PrEP success. Methods: We conducted a discrete choice experiment (DCE) among SGM from all Brazilian regions (September-December/2020). The survey was administered face-to-face (five Brazilian capitals) and online (entire country). We used a D-efficient zero-prior blocked experimental design to select 60 paired-profile DCE choice tasks. Findings: The total sample size was 3924 (90.5% MSM; 7.2% TGW and 2.3% non-binary or gender diverse persons). In random-effects logit models, highest levels of protection and "no side effects" were the most important attribute levels. For "presentation", injectable and implant were preferred over oral. Participants were willing to accept a 4.1% protection reduction to receive injectable PrEP or a 4.2% reduction if PrEP were taken monthly. The largest class in the latent class models was defined predominantly by the preference for the highest HIV protection level (p < 0.005). Respondents in this class also preferred no side effects, injectable and implant presentations. Interpretation: Higher HIV protection, no side effects, and presentation, whether injectable or implant, were the most important attributes in PrEP preferences. Protection against HIV was the most important attribute. PrEP programs should make available technologies such as long-acting presentations that could reunite the most desired attributes, thus maximizing acceptability and user-appropriateness. Funding: Unitaid.

Ambulatory and hospitalized patients with suspected and confirmed mpox: an observational cohort study from Brazil.

Background: By October 30, 2022, 76,871 cases of mpox were reported worldwide, with 20,614 cases in Latin America. This study reports characteristics of a case series of suspected and confirmed mpox cases at a referral infectious diseases center in Rio de Janeiro, Brazil. Methods: This was a single-center, prospective, observational cohort study that enrolled all patients with suspected mpox between June 12 and August 19, 2022. Mpox was confirmed by a PCR test. We compared characteristics of confirmed and non-confirmed cases, and among confirmed cases according to HIV status using distribution tests. Kernel estimation was used for exploratory spatial analysis. Findings: Of 342 individuals with suspected mpox, 208 (60.8%) were confirmed cases. Compared to non-confirmed cases, confirmed cases were more frequent among individuals aged 30-39 years, cisgender men (96.2% vs. 66.4%; p < 0.0001), reporting recent sexual intercourse (95.0% vs. 69.4%; p < 0.0001) and using PrEP (31.6% vs. 10.1%; p < 0.0001). HIV (53.2% vs. 20.2%; p < 0.0001), HCV (9.8% vs. 1.1%; p = 0.0046), syphilis (21.2% vs. 16.3%; p = 0.43) and other STIs (33.0% vs. 21.6%; p = 0.042) were more frequent among confirmed mpox cases. Confirmed cases presented more genital (77.3% vs. 39.8%; p < 0.0001) and anal lesions (33.1% vs. 11.5%; p < 0.0001), proctitis (37.1% vs. 13.3%; p < 0.0001) and systemic signs and symptoms (83.2% vs. 64.5%; p = 0.0003) than non-confirmed cases. Compared to confirmed mpox HIV-negative, HIV-positive individuals were older, had more HCV coinfection (15.2% vs. 3.7%; p = 0.011), anal lesions (45.7% vs. 20.5%; p < 0.001) and clinical features of proctitis (45.2% vs. 29.3%; p = 0.058). Interpretation: Mpox transmission in Rio de Janeiro, Brazil, rapidly evolved into a local epidemic, with sexual contact playing a crucial role in its dynamics and high rates of coinfections with other STI. Preventive measures must address stigma and social vulnerabilities. Funding: Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (INI-Fiocruz).

HIV knowledge and its correlation with the Undetectable = Untransmittable slogan in Brazil.

Knowledge about HIV transmission and prevention is a necessary step for adopting preventive behaviors. We assessed HIV knowledge and its correlation with the perceived accuracy of the "Undetectable = Untransmittable" (U=U) slogan in an online sample with 401 adult Brazilians. Overall, 28% of participants showed high HIV knowledge level. The perceived accuracy of the U=U slogan significantly correlated with HIV knowledge. Younger participants, those reporting lower income or lower education, or who had never tested for HIV showed poorer HIV knowledge. Filling gaps of knowledge among specific populations is urgent in order to increase preventive behaviors and decrease HIV stigma.

Comparing Web-Based Venues to Recruit Gay, Bisexual, and Other Cisgender Men Who Have Sex With Men to a Large HIV Prevention Service in Brazil: Evaluation Study.

BACKGROUND: Internet and mobile phones, widely available in Brazil, could be used to disseminate information about HIV prevention and to recruit gay, bisexual, and other cisgender men who have sex with men (MSM) to HIV prevention services. Data evaluating the characteristics of MSM recruited through different web-based strategies and estimating their cost and yield in the country are not available. OBJECTIVE: We aimed to describe a web-based recruitment cascade, compare the characteristics of MSM recruited to a large HIV prevention service in Rio de Janeiro according to web-based venues, and estimate the cost per participant for each strategy. METHODS: We promoted advertisements on geosocial networking (GSN) apps (Hornet and Grindr) and social media (Facebook and Instagram) from March 2018 to October 2019. The advertisements invited viewers to contact a peer educator to schedule a visit at the HIV prevention service. Performance of web-based recruitment cascade was based on how many MSM (1) were reached by the advertisement, (2) contacted the peer educator, and (3) attended the service. We used chi-square tests to compare MSM recruited through GSN apps and social media. The estimated advertisement cost to recruit a participant was calculated by dividing total advertisement costs by number of participants who attended the service or initiated preexposure prophylaxis (PrEP). RESULTS: Advertisement reached 1,477,344 individuals; 1270 MSM contacted the peer educator (86 contacts per 100,000 views)-564 (44.4%), 401 (31.6%) and 305 (24.0%)-through social media, Grindr, and Hornet. Among the 1270 individuals who contacted the peer educator, 36.3% (n=461) attended the service with similar proportion for each web-based strategy (social media: 203/564, 36.0%; Grindr: 152/401, 37.9%; and Hornet: 107/305, 35.1%). MSM recruited through GSN apps were older (mean age 30 years vs 26 years; P<.001), more frequently self-reported as White (111/247, 44.9% vs 62/191, 32.5%; P=.03), and had higher schooling level (postsecondary: 157/254, 61.8% vs 94/194, 48.5%; P=.007) than MSM recruited through social media. GSN apps recruited MSM with higher HIV risk as measured by PrEP eligibility (207/239, 86.6% vs 133/185, 71.9%; P<.001) compared with social media, but there was no difference in PrEP uptake between the two strategies (P=.22). The estimated advertisement costs per participant attending the HIV prevention service were US $28.36 for GSN apps and US $12.17 for social media. The estimated advertisement costs per participant engaging on PrEP were US $58.77 for GSN apps and US $27.75 for social media. CONCLUSIONS: Social media and GSN app advertisements were useful to disseminate information on HIV prevention strategies and to recruit MSM to a large HIV prevention service in Brazil. Compared to GSN apps, social media advertisements were less expensive and reached more vulnerable and younger MSM. Digital marketing campaigns should use different and complementary web-based venues to reach a plurality of MSM.

Diretrizes para organização, funcionamento e avaliação de farmácias de ensaios clínicos no Brasil: revisão de escopo / Guidelines for organization, operation and evaluation of clinical trials pharmacies in Brazil: a scope review

Resumo O desenvolvimento de novos medicamentos depende de etapas científicas que culminam nos ensaios clínicos em seres humanos. A farmácia de ensaios clínicos (FEC) é o local destinado ao recebimento, preparação, armazenamento e dispensação do produto investigacional (PI). Para tanto, deve possuir infraestrutura e procedimentos que garantam a segurança do participante e a qualidade da pesquisa. Este trabalho teve por objetivo sistematizar diretrizes para FEC no Brasil. Foi realizada uma revisão de escopo e as diretrizes foram organizadas utilizando o método de Ishikawa ("método 6Ms"). No total foram selecionadas 51 publicações, sendo 39 diretrizes e normas e 12 artigos científicos para cada "M"; 25 descreveram o ciclo de assistência farmacêutica (procedimentos para assegurar a segurança dos participantes, desde a requisição do produto até a destinação final), 14 indicadores de qualidade, 12 de recursos humanos, 11 de infraestrutura e recursos materiais e 5 descreveram PIs. para organização, funcionamento e avaliação de FEC no Brasil e corroboram a necessidade da presença do profissional farmacêutico no ciclo da assistência farmacêutica no contexto dos ensaios clínicos, contribuindo ainda na preparação para monitorias, auditorias e inspeções de agências regulatórias.

Abstract The development of new drugs depends on several scientific steps, which culminate in clinical trials. The clinical trials pharmacy (CTP) is the place for receiving, preparing, storing and dispensing the investigational product or study drug. Therefore, it must have infrastructure and procedures that guarantee participant safety and quality of research data. This study aimed to systematize guidelines for CTP in Brazil. We conducted a scope review and organized the results using the Ishikawa Method (6Ms). In total, 51 publications were selected for each "M", 39 laws, regulations or guidelines and 12 scientific articles: 25 publications for pharmaceutical services (pharmacy procedures to ensure participant safety from investigational product ordering to final disposition), 14 for Quality Indicators, 12 for Human Resources, 11 for Infrastructure, 11 for Material Resources and 5 for Investigational Product. Our results synthesize information for the organization, operation and evaluation of CTP in Brazil, emphasizes the inclusion of the pharmacist within the clinical trials context, and contributes to preparation for monitoring, auditing, and inspections conducted by regulatory agencies.

Guidelines for organization, operation and evaluation of clinical trials pharmacies in Brazil: a scope review. / Diretrizes para organização, funcionamento e avaliação de farmácias de ensaios clínicos no Brasil: revisão de escopo.

The development of new drugs depends on several scientific steps, which culminate in clinical trials. The clinical trials pharmacy (CTP) is the place for receiving, preparing, storing and dispensing the investigational product or study drug. Therefore, it must have infrastructure and procedures that guarantee participant safety and quality of research data. This study aimed to systematize guidelines for CTP in Brazil. We conducted a scope review and organized the results using the Ishikawa Method (6Ms). In total, 51 publications were selected for each "M", 39 laws, regulations or guidelines and 12 scientific articles: 25 publications for pharmaceutical services (pharmacy procedures to ensure participant safety from investigational product ordering to final disposition), 14 for Quality Indicators, 12 for Human Resources, 11 for Infrastructure, 11 for Material Resources and 5 for Investigational Product. Our results synthesize information for the organization, operation and evaluation of CTP in Brazil, emphasizes the inclusion of the pharmacist within the clinical trials context, and contributes to preparation for monitoring, auditing, and inspections conducted by regulatory agencies.

O desenvolvimento de novos medicamentos depende de etapas científicas que culminam nos ensaios clínicos em seres humanos. A farmácia de ensaios clínicos (FEC) é o local destinado ao recebimento, preparação, armazenamento e dispensação do produto investigacional (PI). Para tanto, deve possuir infraestrutura e procedimentos que garantam a segurança do participante e a qualidade da pesquisa. Este trabalho teve por objetivo sistematizar diretrizes para FEC no Brasil. Foi realizada uma revisão de escopo e as diretrizes foram organizadas utilizando o método de Ishikawa ("método 6Ms"). No total foram selecionadas 51 publicações, sendo 39 diretrizes e normas e 12 artigos científicos para cada "M"; 25 descreveram o ciclo de assistência farmacêutica (procedimentos para assegurar a segurança dos participantes, desde a requisição do produto até a destinação final), 14 indicadores de qualidade, 12 de recursos humanos, 11 de infraestrutura e recursos materiais e 5 descreveram PIs. para organização, funcionamento e avaliação de FEC no Brasil e corroboram a necessidade da presença do profissional farmacêutico no ciclo da assistência farmacêutica no contexto dos ensaios clínicos, contribuindo ainda na preparação para monitorias, auditorias e inspeções de agências regulatórias.

A Technology-Based Intervention Among Young Men Who Have Sex With Men and Nonbinary People (The Conectad@s Project): Protocol for A Vanguard Mixed Methods Study.

BACKGROUND: In many parts of the world, including Brazil, uptake for biomedical interventions has been insufficient to reverse the HIV epidemic among key populations at high risk for HIV, including men who have sex with men. Young MSM (YMSM), particularly Black YMSM, have high HIV incidence, low viral suppression, and low preexposure prophylaxis (PrEP) uptake and adherence. Therefore, novel approaches to increase the HIV biomedical interventions uptake by YMSM are urgently needed. OBJECTIVE: We describe the Conectad@s Project, which aims to: (1) estimate the prevalence and incidence of HIV and other sexually transmitted infections, the onset of sexual risk behavior, and barriers to biomedical interventions among YMSM aged 18 to 24 years in Rio de Janeiro, Brazil; and (2) conduct a technology-based adherence intervention study to promote a rapid linkage of YMSM to HIV care or prevention, and support and sustain adherence. METHODS: A cross-sectional survey will be conducted with 400 YMSM recruited using respondent-driven sampling (RDS) adapted for social media-based sampling, preceded by a formative phase. HIV and sexually transmitted infections testing will be conducted, including early HIV infection biomarker detection. Behavioral, partnership, network, and structural measures will be collected through structured questionnaires. All individuals recruited for the survey will have access to HIV risk assessment, antiretroviral therapy (ART), PrEP, prevention counseling, and a technology-based adherence intervention. Those who accept the adherence intervention will receive weekly text messages via a social networking app (WhatsApp) for 24 weeks, with follow-up data collected over 48 weeks. RESULTS: The Conectad@s project has been approved by our local institutional review board (#CAAE 26086719.0.0000.4262) in accordance with all applicable regulations. Questionnaires for the RDS survey and intervention were developed and tested in 2020, formative interviews were conducted in January and February 2021 to guide the development of the RDS, and enrollment is planned to begin in early 2022. CONCLUSIONS: The Conectad@s Project is a vanguard study that, for the first time, will apply digital RDS to sample and recruit YMSM in Brazil and rapidly connect them to ART, PrEP, or prevention counseling through a technology-based adherence intervention. RDS will allow us to estimate HIV prevalence among YMSM and measure HIV infection biomarkers in the context of the onset of risky behavior. The data will lay the groundwork to adapt and implement HIV prevention strategies, identify barriers to the earliest HIV infection diagnosis, immediate ART or PrEP initiation, and detect new clusters of HIV transmission. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34885.

[Barriers and facilitators for access to PrEP by vulnerable populations in Brazil: the ImPrEP Stakeholders Study]. / Barreiras e facilitadores do acesso de populações vulneráveis à PrEP no Brasil: Estudo ImPrEP Stakeholders.

HIV preexposure prophylaxis (PrEP) has been considered a fundamental strategy for controlling the HIV/AIDS epidemic, and since 2018 it has been the object of an implementation study (ImPrEP Stakeholders Study), conducted in Brazil, México, and Peru. A qualitative component of this study was developed with the objective of identifying the social and structural contexts that involve and organize the supply of PrEP services in Brazil, the stakeholders' subjectivities, and the different perceptions that can impact the strategy's implementation. The current article's focus was to analyze access by vulnerable populations to PrEP services from the perspective of managers, health professionals, leaders or activists, and users of PrEP. This was a qualitative study using a comprehensive methodology, conducted in six Brazilian state capitals, interviewing 71 key actors from November 2018 to May 2019. The analysis was based on access analysis models as proposed by Giovanella & Fleury, McIntyre et al. and Penchansky & Thomas. The results are presented along three lines: "perceptions of combined prevention and PrEP", "availability and adequacy: profile and structure of services in the context of ImPrEP", and "acceptability: attitudes and practices of health professionals and users".

A profilaxia pré-exposição ao HIV (PrEP) tem sido considerada uma estratégia fundamental para o controle da epidemia de HIV/aids, e desde 2018 tem sido objeto de estudo de implementação (Estudo ImPrEP Stakeholders), realizado no Brasil, no México e no Peru. Um componente qualitativo desse estudo foi desenvolvido com o objetivo de identificar os contextos sociais e estruturais que envolvem e organizam a oferta de serviços de PrEP no Brasil, as subjetividades dos atores envolvidos e as diferentes percepções que podem impactar a efetivação dessa estratégia. O presente artigo teve como foco de análise o acesso das populações vulneráveis aos serviços de PrEP, na perspectiva de gestores, profissionais de saúde, lideranças ou ativistas e usuários de PrEP. É um estudo qualitativo com o uso de metodologia compreensiva, realizado em seis capitais brasileiras, em que foram entrevistados 71 atores-chave no período de novembro de 2018 a maio de 2019. A análise foi pautada pelos modelos analíticos sobre acesso propostos por Giovanella & Fleury, McIntyre et al. e Penchansky & Thomas. Os resultados são apresentados com base em três eixos: "percepções sobre prevenção combinada e PrEP"; "disponibilidade e adequação: perfil e estrutura dos serviços no contexto do ImPrEP"; e "aceitabilidade: atitudes e práticas dos profissionais de saúde e usuários".

La profilaxis preexposición al VIH (PrEP) ha sido considerada una estrategia fundamental para el control de la epidemia de VIH/sida y desde 2018 ha sido objeto de estudio de implementación (Estudio ImPrEP Stakeholders), realizado en Brasil, México y Perú. Un componente cualitativo de este estudio se desarrolló con el objetivo de identificar los contextos sociales y estructurales que engloban y organizan la oferta de servicios de PrEP en Brasil, las subjetividades de los actores implicados y las diferentes percepciones que pueden impactar en hacer efectiva esa estrategia. El objetivo de este artículo es el análisis del acceso de las poblaciones vulnerables a los servicios de PrEP, desde la perspectiva de los gestores, profesionales de salud, líderes o activistas y usuarios de la PrEP. Se trata de un estudio cualitativo con uso de metodología comprensiva, realizado en seis capitales brasileñas, en las que fueron entrevistados 71 actores-clave, durante el período de noviembre de 2018 a mayo de 2019. El análisis se pautó mediante modelos analíticos sobre acceso, propuestos por Giovanella & Fleury, McIntyre et al. y Penchansky & Thomas. Los resultados se presentan a partir de tres ejes: "percepciones sobre prevención combinada y PrEP", "disponibilidad y adecuación: perfil y estructura de los servicios en el contexto de la ImPrEP" y "aceptabilidad: actitudes y prácticas de los profesionales de salud y usuarios".

Barreiras e facilitadores do acesso de populações vulneráveis à PrEP no Brasil: Estudo ImPrEP Stakeholders / Barriers and facilitators for access to PrEP by vulnerable populations in Brazil: the ImPrEP Stakeholders Study / Barreras y facilitadores de acceso de poblaciones vulnerables a la PrEP en Brasil: Estudio ImPrEP Stakeholders

Resumo: A profilaxia pré-exposição ao HIV (PrEP) tem sido considerada uma estratégia fundamental para o controle da epidemia de HIV/aids, e desde 2018 tem sido objeto de estudo de implementação (Estudo ImPrEP Stakeholders), realizado no Brasil, no México e no Peru. Um componente qualitativo desse estudo foi desenvolvido com o objetivo de identificar os contextos sociais e estruturais que envolvem e organizam a oferta de serviços de PrEP no Brasil, as subjetividades dos atores envolvidos e as diferentes percepções que podem impactar a efetivação dessa estratégia. O presente artigo teve como foco de análise o acesso das populações vulneráveis aos serviços de PrEP, na perspectiva de gestores, profissionais de saúde, lideranças ou ativistas e usuários de PrEP. É um estudo qualitativo com o uso de metodologia compreensiva, realizado em seis capitais brasileiras, em que foram entrevistados 71 atores-chave no período de novembro de 2018 a maio de 2019. A análise foi pautada pelos modelos analíticos sobre acesso propostos por Giovanella & Fleury, McIntyre et al. e Penchansky & Thomas. Os resultados são apresentados com base em três eixos: "percepções sobre prevenção combinada e PrEP"; "disponibilidade e adequação: perfil e estrutura dos serviços no contexto do ImPrEP"; e "aceitabilidade: atitudes e práticas dos profissionais de saúde e usuários".

Abstract: HIV preexposure prophylaxis (PrEP) has been considered a fundamental strategy for controlling the HIV/AIDS epidemic, and since 2018 it has been the object of an implementation study (ImPrEP Stakeholders Study), conducted in Brazil, México, and Peru. A qualitative component of this study was developed with the objective of identifying the social and structural contexts that involve and organize the supply of PrEP services in Brazil, the stakeholders' subjectivities, and the different perceptions that can impact the strategy's implementation. The current article's focus was to analyze access by vulnerable populations to PrEP services from the perspective of managers, health professionals, leaders or activists, and users of PrEP. This was a qualitative study using a comprehensive methodology, conducted in six Brazilian state capitals, interviewing 71 key actors from November 2018 to May 2019. The analysis was based on access analysis models as proposed by Giovanella & Fleury, McIntyre et al. and Penchansky & Thomas. The results are presented along three lines: "perceptions of combined prevention and PrEP", "availability and adequacy: profile and structure of services in the context of ImPrEP", and "acceptability: attitudes and practices of health professionals and users".

Resumen: La profilaxis preexposición al VIH (PrEP) ha sido considerada una estrategia fundamental para el control de la epidemia de VIH/sida y desde 2018 ha sido objeto de estudio de implementación (Estudio ImPrEP Stakeholders), realizado en Brasil, México y Perú. Un componente cualitativo de este estudio se desarrolló con el objetivo de identificar los contextos sociales y estructurales que engloban y organizan la oferta de servicios de PrEP en Brasil, las subjetividades de los actores implicados y las diferentes percepciones que pueden impactar en hacer efectiva esa estrategia. El objetivo de este artículo es el análisis del acceso de las poblaciones vulnerables a los servicios de PrEP, desde la perspectiva de los gestores, profesionales de salud, líderes o activistas y usuarios de la PrEP. Se trata de un estudio cualitativo con uso de metodología comprensiva, realizado en seis capitales brasileñas, en las que fueron entrevistados 71 actores-clave, durante el período de noviembre de 2018 a mayo de 2019. El análisis se pautó mediante modelos analíticos sobre acceso, propuestos por Giovanella & Fleury, McIntyre et al. y Penchansky & Thomas. Los resultados se presentan a partir de tres ejes: "percepciones sobre prevención combinada y PrEP", "disponibilidad y adecuación: perfil y estructura de los servicios en el contexto de la ImPrEP" y "aceptabilidad: actitudes y prácticas de los profesionales de salud y usuarios".

HIV knowledge and its correlation with the Undetectable = Untransmittable slogan in Brazil

ABSTRACT Knowledge about HIV transmission and prevention is a necessary step for adopting preventive behaviors. We assessed HIV knowledge and its correlation with the perceived accuracy of the "Undetectable = Untransmittable" (U=U) slogan in an online sample with 401 adult Brazilians. Overall, 28% of participants showed high HIV knowledge level. The perceived accuracy of the U=U slogan significantly correlated with HIV knowledge. Younger participants, those reporting lower income or lower education, or who had never tested for HIV showed poorer HIV knowledge. Filling gaps of knowledge among specific populations is urgent in order to increase preventive behaviors and decrease HIV stigma.

Preferences for pre-exposure prophylaxis (PrEP) among men who have sex with men and transgender women at risk of HIV infection: a multicentre protocol for a discrete choice experiment in Brazil.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) is an important and well-established prevention strategy for sexual acquisition of HIV. In Brazil, transgender women (TGW) and men who have sex with men (MSM) bear the largest burden among key populations. Little is known about preferences for PrEP characteristics in these vulnerable populations in Latin America. The goal of this study is to investigate preferences of TGW and MSM with respect to PrEP characteristics, whether current user or not, and to assess any attributes and levels that may improve the decision to start using PrEP (uptake) and optimal continuity of use (adherence), which are important dimensions for PrEP success. METHODS AND ANALYSIS: We hereby outline the protocol of a discrete choice experiment (DCE) to be conducted among TGW and MSM in Brazil. The study will be carried out in two phases. The first phase involves literature review and qualitative approaches including in-depth interviews to inform the development of the DCE (attributes and levels). The second phase entails the DCE survey and supporting questions pertaining to sociodemographic and risk behaviour information. The survey is aimed at current PrEP users and non-users, consisting of two modes of administration: face to face in five Brazilian capitals (Rio de Janeiro, Brasília, Manaus, Porto Alegre and Salvador) and online targeting the entire country. A D-efficient zero-prior blocked experimental design will be used to select 60 paired-profile DCE choice tasks, in which participants will be randomly assigned to one of four groups and presented with a set of 15 choice tasks. The planned sample size is 1000 volunteers. ETHICS, TIMELINE AND DISSEMINATION: The study was approved by Comitê de Ética em Pesquisa-Instituto Nacional de Infectologia Evandro Chagas-INI/FIOCRUZ, CEP/INI, CAAE 28416220.2.1001.5262, approval number 3.979.759 in accordance with the Comissão Nacional de Ética em Pesquisa (CONEP-Brazilian National Board of Research Ethics). The study will be conducted between 2020 and 2021. The results will be disseminated to the scientific community and to the public in general through publications in published in peer-reviewed journals and in scientific conferences.

Pre-exposure prophylaxis 2.0: new drugs and technologies in the pipeline.

Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine was adopted by WHO as a strategy to reduce HIV incidence. Although shown to be highly effective in reducing HIV acquisition, the protective efficacy of oral tenofovir disoproxil fumarate and emtricitabine relies on optimal adherence, which poses a challenge for a key portion of the most at-risk populations (women, young individuals [15-24 years], racial and ethnic minority men who have sex with men, and transgender women). New PrEP agents in clinical development include novel oral agents (eg, tenofovir alafenamide and islatravir [also known as MK-8591]), long-acting injectables (eg, cabotegravir), vaginal rings, broadly neutralising monoclonal antibodies, topical products (including gels, films, and enemas), and multipurpose technologies. In addition, new drug delivery systems, such as implants and transdermal devices, are promising strategies that are being developed for HIV prevention. The ultimate goal of this new PrEP research agenda is to expand the available PrEP regimens and offer preventive technologies that will appeal to a wide variety of individuals with different needs over the course of their sexually active lifespan.

Authorship Correction: Factors Associated With Willingness to Use Pre-Exposure Prophylaxis in Brazil, Mexico, and Peru: Web-Based Survey Among Men Who Have Sex With Men.

[This corrects the article DOI: 10.2196/13771.].