Efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for PrEP is strongly dependent on the adherence. We examined the concordance between indirect adherence measures and protective ...drug levels among participants retained through 48 weeks in the PrEP Brasil Study.
PrEP Brasil was a prospective, multicenter, open-label demonstration project evaluating PrEP provision for men who have sex with men (MSM) and transgender women (TGW) at higher risk for HIV infection within the setting of Brazilian Public Health System. Three indirect adherence measures were obtained at week 48: medication possession ratio (MPR), pill count and self-report (30-days recall). Tenofovir diphosphate (TFV-DP) concentration in Dried Blood Spot (DBS) was measured at week 48. Areas under (AUC) the receiver operating characteristics (ROC) curve were used to evaluate the concordance between achieving protective drug levels (TFV-DP≥700fmol/punch) and the indirect adherence measures. Youden's index and distance to corner were used to determine the optimal cutoff points for each indirect adherence measure. We calculated sensitivity, specificity, negative (NPV) and positive (PPV) predictive values for the found cutoff points. Finally, Delong test was used to compare AUCs.
From April, 2014 to July, 2016, 450 participants initiated PrEP, 375(83.3%) were retained through 48 weeks. Of these, 74% (277/375) had TFV-DP ≥700fmol/punch. All adherence measures discriminated between participants with and without protective drug levels (AUC>0.5). High indirect adherence measure was predictive of protective drug levels (PPV>0.8) while low indirect adherence measure was not predictive of lack of protective drug levels (NPV<0.5). No significant differences were found between the adherence methods (p = 0.44).
Low-burden measurements such as MPR and self-report can be used to predict PrEP adherence in a public health context in Brazil for MSM and TGW retained through 48 weeks. Clinical Trial Number: NCT01989611.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
We describe temporal trends in the mortality rates and factors associated with AIDS and non-AIDS related mortality at the Evandro Chagas Clinical Research Institute (IPEC), Oswaldo Cruz Foundation ...(FIOCRUZ).
Adult patients enrolling from 1986 through 2009 with a minimum follow up of 60 days were included. Vital status was exhaustively checked using patients' medical charts, through active contact with individuals and family members and by linkage with the Rio de Janeiro Mortality database using a previously validated algorithm. The CoDe protocol was used to establish the cause of death. Extended Cox proportional hazards models were used for multivariate modeling.
A total of 3530 individuals met the inclusion criteria, out of which 868 (24.6%) deceased; median follow up per patient was 3.9 years (interquartile range 1.7-9.2 years). The dramatic decrease in the overall mortality rates was driven by AIDS-related causes that decreased from 9.19 deaths/100PYs n 1986-1991 to 1.35/100PYs in 2007-2009. Non-AIDS related mortality rates remained stable overtime, at around 1 death/100PYs. Immunodeficiency significantly increased the hazard of both AIDS-related and non-AIDS-related causes of death, while HAART use was strongly associated with a lower hazard of death from either cause.
Our results confirm the remarkable decrease in AIDS-related mortality as the HIV epidemic evolved and alerts to the conditions not traditionally related to HIV/AIDS which are now becoming more frequent, needing careful monitoring.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Introduction
The HIV epidemic continues to disproportionately impact Latin‐American transgender women (TGW). We assessed factors associated with long‐term pre‐exposure prophylaxis (PrEP) engagement ...and adherence among TGW enrolled in the Implementation of PrEP (ImPrEP) study, the largest PrEP demonstration study in Latin America.
Methods
HIV‐negative TGW aged ≥18 years reporting 1+eligibility criteria in the 6 months prior to enrolment (e.g. sex partner known to be living with HIV, condomless anal sex CAS, transactional sex or having a sexually transmitted infection STI) who could safely take PrEP were enrolled. Follow‐up visits were conducted at 4 weeks and then quarterly. We conducted logistic regression to identify factors associated with long‐term PrEP engagement (3+ follow‐up visits in 52 weeks) and complete self‐reported adherence (no missed pills in the past 30 days) during follow‐up. For both outcomes, we constructed multivariable models controlling for country, socio‐demographics, sexual behaviour, substance use, STIs and self‐reported adherence at 4 weeks (long‐term engagement outcome only).
Results
From March 2018 to June 2021, ImPrEP screened 519 TGW, enrolled 494 (Brazil: 190, Mexico: 66 and Peru: 238) and followed them for 52 weeks. At baseline, 27.5% of TGW were aged 18–24 years, 67.8% were mixed‐race and 31.6% had >secondary education. Most, 89.9% reported CAS, 61.9% had >10 sex partners and 71.9% reported transactional sex. HIV incidence was 1.82 cases per 100 person‐years (95% confidence interval CI: 0.76–4.38). Almost half of TGW (48.6%) had long‐term PrEP engagement, which was positively associated with reporting complete adherence at week 4 (aOR:2.94 95%CI:1.88–4.63) and was inversely associated with reporting CAS with unknown‐HIV partner (aOR:0.52 95%CI:0.34–0.81), migration (aOR:0.54 95%CI:0.34–0.84), and being from Mexico (aOR:0.28 95%CI:0.14–0.53). Self‐reported adherence was associated with TGW aged >34 (aOR:1.61 95%CI:1.10–2.34) compared to those aged 25–34 and those with >secondary education (aOR:1.55 95%CI:1.10–2.19) and was lower among TGW from Peru (aOR:0.29 95%CI:0.21–0.41) or reporting PrEP‐related adverse effects (aOR:0.63 95%CI:0.42–0.92).
Conclusions
Although TGW were willing to enrol in ImPrEP, long‐term PrEP engagement and complete self‐reported adherence were limited, and HIV incidence remained relatively high. A successful HIV prevention agenda should include trans‐specific interventions supporting oral PrEP and exploring long‐acting PrEP strategies for TGW.
Brazil has the largest population of individuals living with HIV/AIDS in Latin America with a disproportional prevalence of infection among men who have sex with men (MSM). This study evaluated PrEP ...awareness by age (18-24, 25-35, ≥36 years), its associated factors and the willingness to use HIV prevention technologies among MSM using a GSN app in Brazil. Inclusion criteria were ≥18 years-old, cisgender men and HIV-negative serostatus. Of 7242 individuals, 4136 (57%) completed the questionnaire. PrEP awareness was reported by 51% (though lower among MSM aged 18-24 and ≥36 years) and its associated factors were higher family income, most friends with the same sexual orientation, high number of male sexual partners and marijuana use. HIV testing (never vs. at least once) lead to an almost 3-fold increase in the odds of PrEP awareness. High HIV risk perception led to increased PrEP awareness only among MSM aged 18-24 years. A total of 2335 (56%) was willing to use daily oral PrEP. PrEP awareness remains low in Brazil and mobile tools are key strategies to reach MSM and increase awareness of prevention technologies. Community-based interventions could add to online campaigns to reach the most vulnerable, which include young, non-white and lower-income MSM.
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DOBA, IJS, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
•The prevalence of sexualized drug use among MSM from Rio de Janeiro was 64 %.•Moderate/high risk for substance use disorders were associated with sexualized drug use.•MSM in PrEP programs should be ...screened for substance use treatment.
We evaluated the prevalence of sexualized drug use (Chemsex) and its association with moderate/high risk for substance use disorders and HIV sexual risk behavior among men who have sex with men (MSM).
We conducted a cross-sectional web-based survey among MSM from Rio de Janeiro (Brazil). The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was used to screen people at moderate/high-risk for substance use disorders. Individuals found to be using substances in the prior three months were asked if they used before/during sex. Sexualized drug use was classified into: no sexualized drug use, sex using only alcohol (alcohol-sex), sex using only illicit drugs (drug-sex) and sex using alcohol and illicit drugs (alcohol-drug-sex). The questionnaire included questions about sociodemographic, HIV status/prevention and risk behavior. A multinomial regression model was performed to assess the factors associated with sexualized drug use.
Overall, 1048 MSM completed the questionnaire; median age was 29 years. Prevalence of alcohol and illicit drug use in previous 3 months was 89 % and 49 %, respectively. Most MSM (64 %) reported sexualized drug use: 28 % alcohol-sex, 9 % drug-sex and 27 % alcohol-drug-sex. Median ASSIST scores were higher among those reporting sexualized drug use compared to no use. All HIV sexual risk behavior variables presented increasing prevalence across the outcome categories. In the adjusted multivariate model, having moderate/high-risk for substance use disorders were associated with sexualized drug use.
MSM reporting sexualized drug use should receive brief intervention for substance use disorders and be evaluated for combination HIV prevention strategies including PrEP.
Carotid intima-media thickness (cIMT) has been used as an early marker of atherosclerotic disease in the general population. Recently its role among HIV-infected patients has been questioned. To ...date, no Brazilian study has compared cIMT in respect to HIV status.
We compared data from 535 patients actively followed in a prospective cohort in Rio de Janeiro (HIV group); 88 HIV-negative individuals who were nominated by patients (friend controls-FCs); and 10,943 participants of the ELSA-Brasil study. Linear regression models were used to study associations of the 3 groups and several covariables with cIMT. Propensity scores weighting (PSW) were also employed to balance data.
Median thickness in mm (IQR) were 0.54 (0.49,0.62); 0.58 (0.52,0.68); and 0.57 (0.49,0.70), HIV, FCs and ELSA-Brasil groups, respectively (p-value<0.001). The best linear model chosen did not include the group variables, after adjusting for all the variables chosen, showing no difference of cIMT across groups. Similar results were obtained with PSW. Several traditional CVD risk factors were also significantly associated with cIMT: female gender, higher education and higher HDL were negatively associated while risk factors were older age, current/former smoker, AMI/stroke family history, CVD history, hypertension, DM, higher BMI and total cholesterol.
We show for the first time in a middle-income setting that cIMT, is not different in HIV-infected patients in Rio de Janeiro compared with 2 different groups of non-HIV-infected individuals. Traditional CVD risk factors are associated with this outcome. Our results point out that high standards of care and prevention for CVD risk factors should always be sought both in the HIV-infected and non-infected populations to prevent CVD-related events.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Adult trans women in Brazil are highly impacted by HIV, but little is known about risk for young trans women. Our study was conducted to compare the HIV prevalence and correlates of risk for young ...trans women ages 18-24 years old to adult trans women in Brazil. Trans women were recruited from Rio de Janeiro and Baixada (the metropolitan area of Rio de Janeiro), Brazil (N = 345). Youth ages 18-24 years of age had significantly greater odds of being HIV negative than adults (OR 0.4, 95% CI 0.2-0.6, p = 0.0002), but significantly lower odds of having post-exposure prophylaxis (PEP) knowledge (OR 0.5, 95% CI:0.3-0.9, p = 0.02) and PrEP awareness (OR 0.5, 95% CI: 0.3-0.8, p = 0.01). Young trans women also had significantly higher odds of using substances (OR 1.8, 95% CI 1.1-2.9, p = 0.02) and condomless anal intercourse with their last three sexual partners (OR 1.8, 95% CI: 1.1-3.0, p = 0.03) compared to adults. Already by age 24, one in four trans women in Brazil were infected with HIV pointing to a new generation at high risk of acquiring HIV. HIV prevention interventions are needed to change the healthcare system to reach and engage young trans women.
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DOBA, IJS, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Global mortality from AIDS-related diseases has been declining since 2005, resulting primarily from the widespread use and early initiation of combination antiretroviral therapy. Despite the ...significant improvements, high rates of early mortality, usually defined as that occurring within the 1st year of entry to care, have been observed, especially in resource-limited settings. This analysis draws upon data from an observational cohort of people with HIV (PWH) followed at a reference center for HIV/AIDS care and research in the city of Rio de Janeiro, Brazil, to identify the pattern and factors associated with early mortality.
The study population includes PWH aged 18 or older followed at the National Institute of Infectious Diseases Evandro Chagas who were enrolled between 2004 and 2015. The primary outcome was early mortality, defined as deaths occurring within 1 year of inclusion in the cohort, considering two follow-up periods: 0 to 90 days (very early mortality) and 91 to 365 days (early mortality). Cox proportional hazards models were used to identify the variables associated with the hazard of very early and early mortality.
Overall, 3879 participants contributed with 3616.4 person-years of follow-up. Of 220 deaths, 132 happened in the first 90 days and 88 between 91 and 365 days. Very early mortality rate ratios (MRR) show no statistically significant temporal differences between the periods 2004-2006 to 2013-2015. In contrast, for early mortality, a statistically significant decreasing trend was observed: mortality rates in the periods 2004-2006 (MR = 5.5; 95% CI 3.9-7.8) and 2007-2009 (MR = 3.9; 95% CI 2.7-5.7) were approximately four and three-fold higher when compared to 2013-2015 (MR = 1.4; 95% CI 0.7-2.7). Low CD4 count and prior AIDS-defining illness were strongly associated with higher hazard ratios of death, especially when considering very early mortality.
The present study shows an excess of mortality in the 1st year of follow-up with no changes in the mortality rates within 90 days among PWH from Rio de Janeiro. We note the significant impact of initiating treatment with immunosuppression, as evidenced by the increased risk of death among those with low CD4 cell count and with AIDS-defining illnesses.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The burden of HIV in transgender women (transwomen) in Brazil remains unknown. We aimed to estimate HIV prevalence among transwomen in Rio de Janeiro and to identify predictors of newly diagnosed HIV ...infections.
We recruited transwomen from Rio de Janeiro, Brazil, by respondent-driven sampling. Eligibility criteria were self-identification as transwomen, being 18 years of age or older, living in Rio de Janeiro or its metropolitan area, and having a valid peer recruitment coupon. We recruited 12 seed participants from social movements and formative focus groups who then used peer recruitment coupons to refer subsequent peers to the study. We categorised participants as HIV negative, known HIV infected, or newly diagnosed as HIV infected. We assessed predictors of newly diagnosed HIV infections by comparing newly diagnosed with HIV-negative participants. We derived population estimates with the Respondent-Driven Sampling II estimator.
Between Aug 1, 2015, and Jan 29, 2016, we enrolled 345 eligible transwomen. 29·1% (95% CI 23·2-35·4) of participants had no previous HIV testing (adjusted from 60 participants), 31·2% (18·8-43·6) had HIV infections (adjusted from 141 participants), and 7·0% (0·0-15·9) were newly diagnosed as HIV infected (adjusted from 40 participants). We diagnosed syphilis in 28·9% (18·0-39·8) of participants, rectal chlamydia in 14·6% (5·4-23·8), and gonorrhoea in 13·5% (3·2-23·8). Newly diagnosed HIV infections were associated with black race (odds ratio 22·8 95% CI 2·9-178·9; p=0·003), travesti (34·1 5·8-200·2; p=0·0001) or transsexual woman (41·3 6·3-271·2; p=0·0001) gender identity, history of sex work (30·7 3·5-267·3; p=0·002), and history of sniffing cocaine (4·4 1·4-14·1; p=0·01).
Our results suggest that transwomen bear the largest burden of HIV among any population at risk in Brazil. The high proportion of HIV diagnosis among young participants points to the need for tailored long-term health-care and prevention services to curb the HIV epidemic and improve the quality of life of transwomen in Brazil.
Brazilian Research Council, National Institute of Allergy and Infectious Diseases, Brazilian Sexually Transmitted Disease/AIDS, and Viral Hepatitis Department of the Brazilian Ministry of Health.
After antiretroviral therapy (ART) became available, there was a decline in the number of deaths in persons infected with HIV. Thereafter, there was a decrease in the proportion of deaths attributed ...to opportunistic infections and an increase in the proportion of deaths attributed to chronic comorbidities. Herein we extend previous observations from a nationwide survey on temporal trends in causes of death in HIV-infected patients in Brazil.
We describe temporal trends in causes of death among adults who had HIV/AIDS listed in the death certificate to those who did not. All death certificates issued in Brazil from 1999 to 2011 and listed in the national mortality database were included. Generalized linear mixed-effects logistic models were used to study temporal trends in proportions.
In the HIV-infected population, there was an annual adjusted average increase of 6.0%, 12.0%, 4.0% and 4.1% for cancer, external causes, cardiovascular diseases (CVD) and diabetes mellitus (DM), respectively, compared to 3.0%, 4.0%, 1.0% and 3.9%, in the non-HIV group. For tuberculosis (TB), there was an adjusted average increase of 0.3%/year and a decrease of 3.0%/year in the HIV and the non-HIV groups, respectively. Compared to 1999, the odds ratio (OR) for cancer, external causes, CVD, DM, or TB in the HIV group were, respectively, 2.31, 4.17, 1.76, 2.27 and 1.02, while for the non-HIV group, the corresponding OR were 1.31, 1.63, 1.14, 1.62 and 0.67. Interactions between year as a continuous or categorical variable and HIV were significant (p<0.001) for all conditions, except for DM when year was considered as a continuous variable (p = 0.76).
Non HIV-related co-morbidities continue to increase more rapidly as causes of death among HIV-infected individuals than in those without HIV infection, highlighting the need for targeting prevention measures and surveillance for chronic diseases among those patients.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK