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HIV controllers (HICs) are models of HIV functional cure, although some studies have shown persistent inflammation and increased rates of atherosclerosis in HICs. Since immune activation/inflammation contributes to the pathogenesis of cardiovascular diseases (CVD), we evaluated clinical data and inflammation markers in HIV-1 viremic controllers (VC), elite controllers (EC), and control groups (HIV positive individuals with virological suppression by antiretroviral therapy—cART; HIV negative individuals—HIVneg) to assess whether they presented elevated levels of inflammation markers also associated with CVD. We observed the highest frequencies of activated CD8+ T cells in VCs, while EC and cART groups presented similar but slightly altered frequencies of this marker when compared to the HIVneg group. Regarding platelet activation, both HICs groups presented higher expression of P-selectin in platelets when compared to control groups. Monocyte subset analyses revealed lower frequencies of classical monocytes and increased frequencies of non-classical and intermediate monocytes among cART individuals and in EC when compared to HIV negative individuals, but none of the differences were significant. For VC, however, significant decreases in frequencies of classical monocytes and increases in the frequency of intermediate monocytes were observed in comparison to HIV negative individuals. The frequency of monocytes expressing tissue factor was similar among the groups on all subsets. In terms of plasma markers, VC had higher levels of many inflammatory markers, while EC had higher levels of VCAM-1 and ICAM-1 compared to control groups. Our data showed that VCs display increased levels of inflammation markers that have been associated with CVD risk. Meanwhile, ECs show signals of lower but persistent inflammation, comparable to the cART group, indicating the potential benefits of alternative therapies to decrease inflammation in this group.

Background The HIV epidemic continues to disproportionately burden marginalized populations despite the availability of effective preventive and therapeutic interventions. Transgender women are severely affected by HIV worldwide including in Brazil and other low- and middle-income countries, with evidence of increasing new infections among young people. There is an urgent need for youth-specific HIV prevention and care interventions for young transgender women in Brazil. Objective This study aims to (1) address stigma in the Brazilian public health system and (2) reduce barriers to HIV care and prevention with systems navigation among young transgender women aged 18-24 years in Rio de Janeiro, Brazil. Methods The Brilhar e Transcender (BeT) study is a status-neutral, peer-led, single-arm digital intervention study enrolling 150 young transgender women in Rio de Janeiro, Brazil. The intervention was pilot tested and refined using data from a formative phase. The BeT intervention takes place over 3 months, is delivered remotely via mobile phone and in person by peers, and comprises three components: (1) BeT sessions, (2) digital interactions, and (3) automated messages. Eligibility criteria include identifying as transgender women, being aged 18-24 years, speaking in Portuguese, and living in the Rio de Janeiro metropolitan area in Brazil. The primary outcomes are HIV incidence, pre-exposure prophylaxis uptake, linkage to HIV care, and viral suppression. Primary outcomes were assessed at baseline and quarterly for 12 months. Participants respond to interviewer-based surveys and receive tests for HIV and sexually transmitted infections. Results The study has been approved by the Brazilian and the US local institutional review boards in accordance with all applicable regulations. Study recruitment began in February 2022 and was completed in early July 2022. Plans are to complete the follow-up assessment of study participants on July 2023, analyze the study data, and disseminate intervention results by December 2023. Conclusions Interventions to engage a new generation of transgender women in HIV prevention and care are needed to curb the epidemic. The BeT study will evaluate a digital peer-led intervention for young transgender women in Brazil, which builds on ways young people engage in systems and uses peer-led support to empower transgender youth in self-care and health promotion. A promising evaluation of the BeT intervention may lead to the availability of this rapidly scalable status-neutral HIV intervention that can be translated throughout Brazil and other low- and middle-income countries for young transgender women at high risk of or living with HIV. Trial Registration ClinicalTrials.gov NCT05299645; https://clinicaltrials.gov/ct2/show/NCT05299645 International Registered Report Identifier (IRRID) DERR1-10.2196/44157

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 DERR1-10.2196/34885

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

Objectives Potential interactions between feminizing hormone therapy (FHT) and pre-exposure prophylaxis (PrEP) may be a barrier to PrEP use among transgender women (TGW). We aimed to assess the impact of FHT on PrEP plasma pharmacokinetics (PK) among TGW. Methods This was a PK substudy of the effects of FHT on tenofovir disoproxil fumarate/emtricitabine nested to a trans-specific PrEP demonstration study (NCT03220152). Participants were assigned to receive PrEP only (noFHT) or standardized FHT (sFHT; oestradiol valerate 2–6 mg plus spironolactone 100–300 mg) plus PrEP for 12 weeks, after which they could start any FHT (aFHT). Short- and long-term PK assessment occurred at Weeks 12 and 30–48, respectively (plasma samples prior and 0.5, 1, 2, 4, 6, 8 and 24 h after dose). Non-compartmental PK parameters of tenofovir and emtricitabine were compared as geometric mean ratios (GMRs) between noFHT and PrEP and FHT (sFHT at short-term PK; aFHT at long-term PK) participants. Results No differences in tenofovir and emtricitabine plasma PK parameters were observed between the short-term PK of noFHT (n = 12) and sFHT participants (n = 18), except for emtricitabine Cmax [GMR: 1.15 (95% CI: 1.01–1.32)], or between noFHT short-term PK and aFHT long-term PK (n = 13). Most participants were on oestradiol valerate 2 mg at the short-term PK (56%) and 4 mg at the long-term PK (54%). Median (IQR) oestradiol levels were 56.8 (43.2–65.4) pg/mL at short-term PK (sFHT) and 44.8 (24.70–57.30) pg/mL at long-term PK (aFHT). No participants in this analysis seroconverted during the study. Conclusions Our results indicate no interaction of FHT on tenofovir levels, further supporting PrEP use among TGW using FHT.

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 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.

BACKGROUND Approximately 30% of people living with HIV worldwide are estimated to be unaware of their infection. HIV self-testing (HIVST) is a strategy recommended by the World Health Organization which increases access to and uptake of testing among key populations who are at high risk for HIV infection. OBJECTIVE To describe the development and feasibility of a free, anonymous, Internet-based HIV self-testing (HIVST) strategy designed for men who have sex with men (MSM) in Curitiba, Brazil (E-testing). METHODS The project was developed under the scope of the “A Hora é Agora” (Time is now) program. Individuals aiming to request an HIVST package (2 tests each) answered an anonymous 5-minute questionnaire regarding inclusion criteria and sexual risk behavior. Eligible individuals could receive one package every 6 months for free. Website analytics, response to online questionnaires, packages distribution, and return of test results were monitored via a platform-integrated system. RESULTS Between February 2015 and January 2016, the website documented 17,786 unique visitors with 3,218 provided complete answers to the online questionnaires. Most individuals self-reported being white (77%), young (median age was 25 years, interquartile range 22-31), educated (87.3% complete secondary education or more), and had previously tested for HIV (62.5%). Overall, 2,526 HIVST packages were delivered; of those, 542 (21.4%) reported a result online or by mail (23 reactive and 11 invalid). During the study period, 37 individuals reporting to have used E-testing visited the pre-specified health facility for confirmatory testing (30 positive; 7 negative). CONCLUSIONS E-testing proved highly feasible and acceptable in this study, thus supporting scale-up to additional MSM population centers in Brazil.

BACKGROUND Geosocial networking (GSN) smartphone apps are becoming the main venue for sexual encounters among Brazilian men who have sex with men (MSM). To address the increased HIV incidence in this population, preexposure prophylaxis (PrEP) was recently implemented in the Brazilian public health system in the context of combined HIV prevention. OBJECTIVE This study aimed to describe the characteristics of MSM using GSN apps for sexual encounters, their awareness of prevention strategies, and willingness to use PrEP. METHODS This study was an online cross-sectional study conducted in 10 Brazilian state capitals from July 1 to July 31, 2016. The questionnaire was programmed on SurveyGizmo and advertised in two GSN apps used by MSM to find sexual partners (Hornet and Grindr). Inclusion criteria were >18 years of age, cisgender men, with an HIV-negative status. Eligible individuals answered questions on: demographics; behavior; and knowledge, preferences, and willingness to use PrEP, nonoccupational postexposure prophylaxis (nPEP), HIV self-testing (HIVST), and condoms. Logistic regression modeling was performed to assess the factors associated with daily oral PrEP willingness. RESULTS During the study period, 8885 individuals provided consent and started the questionnaire. Of these, 23.05% (2048/8885) were ineligible, 6837 (6837/8885, 76.94%) initiated, and 5065 (5065/8885, 57.00%) completed the entire questionnaire and were included in the present analysis. Median age was 30 years (interquartile range: 25-36), most self-declared as MSM (4991/5065, 98.54%), white (3194/5065, 63.06%), middle income (2148/5065, 42.41%), and had 12 or more years of schooling (3106/5062, 61.36%). The majority of MSM (3363/5064, 66.41%) scored >10 points (high risk) on The HIV Incidence Risk for MSM Scale, but only 21.39% (1083/5064) had a low perceived likelihood of getting HIV in the next year. Daily use of apps for sex was reported by 35.58% (1798/5054). Most MSM (4327/5065, 85.43%) reported testing for HIV at least once in their lifetime and 9.16% (464/5065) used nPEP in the previous year. PrEP, nPEP, and HIVST awareness was reported by 57.89% (2932/5065), 57.39% (2907/5065), and 26.57% (1346/5065) of participants, respectively. Half of all respondents (2653/5065, 52.38%) were willing to use daily oral PrEP, and this finding was associated with higher numbers of male sexual partners (adjusted odds ratio [AOR] 1.26, 95% CI 1.09-1.47), condomless receptive anal intercourse (AOR 1.27, 95% CI 1.12-1.44), sex with HIV-positive partner versus no HIV-positive partner (one HIV-positive partner: AOR 1.36, 95% CI 1.11-1.67), daily use of apps for sexual encounters (AOR 1.48, 95% CI 1.17-1.87), high and unknown perceived likelihood of getting HIV in the next year (AOR 1.72, 95% CI 1.47-2.02 and AOR 1.39, 95% CI 1.13-1.70), sexually transmitted infection diagnosis (AOR 1.25, 95% CI 1.03-1.51), stimulant use (AOR 1.24, 95% CI 1.07-1.43), PrEP awareness (AOR 1.48, 95% CI 1.30-1.70), and unwillingness to use condoms (AOR 1.16, 95% CI 1.00-1.33). CONCLUSIONS Our results evidenced high-risk scores in the studied population, suggesting the importance of PrEP use. Those individuals presenting risky sexual behaviors were more willing to use PrEP. Nonetheless, only 58% (2932/5065) of individuals had heard about this prevention strategy. Efforts to increase awareness of new prevention strategies are needed, and mobile health tools are a promising strategy to reach MSM.

International audience; BACKGROUND: In high-income settings, the spectrum of morbidity and mortality experienced by Human Immunodeficiency Virus (HIV)-infected individuals receiving combination antiretroviral therapy (cART) has switched from predominantly AIDS-related to non-AIDS-related conditions. In the context of universal access to care, we evaluated whether that shift would apply in Brazil, a middle-income country with universal access to treatment, as compared to France. METHODS: Two hospital-based cohorts of HIV-infected individuals were used for this analysis: the ANRS CO3 Aquitaine Cohort in South Western France and the Evandro Chagas Research Institute (IPEC) Cohort of the Oswaldo Cruz Foundation in Rio de Janeiro, Brazil. Severe morbid events (AIDS- and non-AIDS-related) were defined as all clinical diagnoses associated with a hospitalization of ≥48 hours. Trends in the incidence rate of events and their determinants were estimated while adjusting for within-subject correlation using generalized estimating equations models with an auto-regressive correlation structure and robust standard errors. RESULT: Between January 2000 and December 2008, 7812 adult patients were followed for a total of 41,668 person-years (PY) of follow-up. Throughout the study period, 90% of the patients were treated with cART. The annual incidence rate of AIDS and non-AIDS events, and of deaths significantly decreased over the years, from 6.2, 21.1, and 1.9 AIDS, non-AIDS events, and deaths per 100 PY in 2000 to 4.3, 14.9, and 1.5/100 PY in 2008. The annual incidence rates of non-AIDS events surpassed that of AIDS-events during the entire study period. High CD4 cell counts were associated with a lower incidence rate of AIDS and non-AIDS events as well as with lower rates of specific non-AIDS events, such as bacterial, hepatic, viral, neurological, and cardiovascular conditions. Adjusted analysis showed that severe morbidity was associated with lower CD4 counts and higher plasma HIV RNAs but not with setting (IPEC versus Aquitaine). CONCLUSIONS: As information on severe morbidities for HIV-infected patients remain scarce, data on hospitalizations are valuable to identify priorities for case management and to improve the quality of life of patients with a chronic disease requiring life-long treatment. Immune restoration is highly effective in reducing AIDS and non-AIDS severe morbid events irrespective of the setting.