Long-term HIV care outcomes under universal HIV treatment guidelines: A retrospective cohort study in 25 countries.

BACKGROUND: While national adoption of universal HIV treatment guidelines has led to improved, timely uptake of antiretroviral therapy (ART), longer-term care outcomes are understudied. There is little data from real-world service delivery settings on patient attrition, viral load (VL) monitoring, and viral suppression (VS) at 24 and 36 months after HIV treatment initiation. METHODS AND FINDINGS: For this retrospective cohort analysis, we used observational data from 25 countries in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium's Asia-Pacific, Central Africa, East Africa, Central/South America, and North America regions for patients who were ART naïve and aged ≥15 years at care enrollment between 24 months before and 12 months after national adoption of universal treatment guidelines, occurring 2012 to 2018. We estimated crude cumulative incidence of loss-to-clinic (CI-LTC) at 12, 24, and 36 months after enrollment among patients enrolling in care before and after guideline adoption using competing risks regression. Guideline change-associated hazard ratios of LTC at each time point after enrollment were estimated via cause-specific Cox proportional hazards regression models. Modified Poisson regression was used to estimate relative risks of retention, VL monitoring, and VS at 12, 24, and 36 months after ART initiation. There were 66,963 patients enrolling in HIV care at 109 clinics with ≥12 months of follow-up time after enrollment (46,484 [69.4%] enrolling before guideline adoption and 20,479 [30.6%] enrolling afterwards). More than half (54.9%) were females, and median age was 34 years (interquartile range [IQR]: 27 to 43). Mean follow-up time was 51 months (standard deviation: 17 months; range: 12, 110 months). Among patients enrolling before guideline adoption, crude CI-LTC was 23.8% (95% confidence interval [95% CI] 23.4, 24.2) at 12 months, 31.0% (95% CI [30.6, 31.5]) at 24 months, and 37.2% (95% [CI 36.8, 37.7]) at 36 months after enrollment. Adjusting for sex, age group, enrollment CD4, clinic location and type, and country income level, enrolling in care and initiating ART after guideline adoption was associated with increased hazard of LTC at 12 months (adjusted hazard ratio [aHR] 1.25 [95% CI 1.08, 1.44]; p = 0.003); 24 months (aHR 1.38 [95% CI 1.19, 1.59]; p < .001); and 36 months (aHR 1.34 [95% CI 1.18, 1.53], p < .001) compared with enrollment before guideline adoption, with no before-after differences among patients with no record of ART initiation by end of follow-up. Among patients retained after ART initiation, VL monitoring was low, with marginal improvements associated with guideline adoption only at 12 months after ART initiation. Among those with VL monitoring, VS was high at each time point among patients enrolling before guideline adoption (86.0% to 88.8%) and afterwards (86.2% to 90.3%), with no substantive difference associated with guideline adoption. Study limitations include lags in and potential underascertainment of care outcomes in real-world service delivery data and potential lack of generalizability beyond IeDEA sites and regions included in this analysis. CONCLUSIONS: In this study, adoption of universal HIV treatment guidelines was associated with lower retention after ART initiation out to 36 months of follow-up, with little change in VL monitoring or VS among retained patients. Monitoring long-term HIV care outcomes remains critical to identify and address causes of attrition and gaps in HIV care quality.

Comparison of community and clinic-based blood pressure measurements: A cross-sectional study from Haiti.

Hypertension (HTN) is the leading modifiable cardiovascular disease (CVD) risk factor in low and middle-income countries, and accurate and accessible blood pressure (BP) measurement is essential for identifying persons at risk. Given the convenience and increased use of community BP screening programs in low-income settings, we compared community and clinic BP measurements for participants in the Haiti CVD Cohort Study to determine the concordance of these two measurements. Participants were recruited using multistage random sampling from March 2019 to August 2021. HTN was defined as systolic BP (SBP) ≥ 140mmHg, diastolic BP (DBP) ≥ 90mmHg or taking antihypertensives according to WHO guidelines. Factors associated with concordance versus discordance of community and clinic BP measurements were assessed with multivariable Poisson regressions. Among 2,123 participants, median age was 41 years and 62% were female. Pearson correlation coefficients for clinic versus community SBP and DBP were 0.78 and 0.77, respectively. Using community BP measurements, 36% of participants screened positive for HTN compared with 30% using clinic BPs. The majority of participants had concordant measurements of normotension (59%) or HTN (26%) across both settings, with 4% having isolated elevated clinic BP (≥140/90 in clinic with normal community BP) and 10% with isolated elevated community BP (≥140/90 in community with normal clinic BP). These results underscore community BP measurements as a feasible and accurate way to increase HTN screening and estimate HTN prevalence for vulnerable populations with barriers to clinic access.

The relationship between perceived stress and support with blood pressure in urban Haiti: A cross-sectional analysis.

Haiti is a low-income country whose population lives under repeated and chronic stress from multiple natural disasters, civil unrest, and extreme poverty. Stress has been associated with cardiovascular (CVD) risk factors including hypertension, and the impact of stress on blood pressure may be moderated by support. The distribution of stress, support, and their association with blood pressure has not been well described in low-income countries. We measured stress and support using validated instruments on cross-sectional enrollment data of a population-based cohort of 2,817 adults living in Port-au-Prince, Haiti between March 2019 and April 2021. Stress was measured using the Perceived Stress Scale, while support was measured using the Multidimensional Scale of Perceived Social Support. Continuous scores were categorized into three groups for stress (low (1-5), moderate (6-10), high (11-16), and five groups for support (low (7-21), low-moderate (22-35), moderate (36-49), moderate-high (50-64), high (65-77)). Linear regression models were used to quantify the associations between: 1) support and stress adjusting for age and sex, and 2) stress and blood pressure adjusting for age and sex. A moderation analysis was conducted to assess if support moderated the relationship between stress and blood pressure. The cohort included 59.7% females and the median age was 40 years (IQR 28-55). The majority had an income <1 US dollar per day. The median stress score was moderate (8 out of 16 points, IQR 6-10), and median support score was moderate to high (61 out of 77 points, IQR 49-71). Stress was higher with older ages (60+ years versus 18-29 years: +0.79 points, 95% CI 0.51 to 1.08) and in females (+0.85 points, 95% CI +0.65 to +1.06). Support was higher in males (+3.29 points, 95% CI 2.19 to 4.39). Support was inversely associated with stress, adjusting for age and sex (-0.04 points per one unit increase in support, 95% CI -0.04 to -0.03). Stress was not associated with systolic or diastolic blood pressure after adjustment for age and sex. Support did not moderate the association between stress and blood pressure. In this urban cohort of Haitian adults living with chronic civil instability and extreme poverty, perceived levels of stress and social support were moderate and high, respectively. Contrary to prior literature, we did not find an association between stress and blood pressure. While support was associated with lower stress, it did not moderate the relationship between stress and blood pressure. Participants reported high levels of support, which may be an underutilized resource in reducing stress, potentially impacting health behaviors and outcomes.

Diabetes Epidemiology Among Adults in Port-au-Prince, Haiti: A Cross-Sectional Study.

Introduction: Diabetes mellitus is a chronic noncommunicable disease associated with death and major disability, with increasing prevalence in low- and middle-income countries. There is limited population-based data about diabetes in Haiti. The objective of this study was to assess the prevalence of diabetes and associated factors among adults in Port-au-Prince, Haiti using a population-based cohort. Methods: This study analyzes cross-sectional enrollment data from the population-based Haiti Cardiovascular Disease Cohort Study, conducted using multistage sampling with global positioning system waypoints in census blocks in the metropolitan area of Port-au-Prince, Haiti. A total of 3,005 adults ≥18 years old were enrolled from March 2019 to August 2021. We collected socio-demographic data, health-related behaviors, and clinical data using standardized questionnaires. Diabetes was defined as any of the following criteria: enrollment fasting glucose value ≥ 126 mg/dL or non-fasting glucose ≥ 200 mg/dL, patient self-report of taking diabetes medications, or study physician diagnosis of diabetes based on clinical evaluation. Results: Among 2985 (99.3%) with complete diabetes data, median age was 40 years, 58.1% were female, and 17.2% were obese. The prevalence of diabetes was 5.4% crude, and 5.2% age standardized. In unadjusted analysis, older age, higher body mass index (BMI), low physical activity, low education were associated with a higher odds of diabetes. After multivariable logistic regression, older age [60+ vs 18-29, Odds Ratio (OR)17.7, 95% CI 6.6 to 47.9] and higher BMI (obese vs normal/underweight, OR 2.7, 95% CI 1.7 to 4.4) remained statistically significantly associated with higher odds of diabetes. Conclusion: The prevalence of diabetes was relatively low among adults in Port-au-Prince, but much higher among certain groups (participants who were older and obese). The Haitian health system should be strengthened to prevent, diagnose, and treat diabetes among high-risk groups.

Hypertension continuum of care: Blood pressure screening, diagnosis, treatment, and control in a population-based cohort in Haiti.

Cardiovascular disease (CVD) is the number one cause of death in low-income countries including Haiti, with hypertension (HTN) being the leading risk factor. This study aims to identify gaps in the HTN continuum of screening, diagnosis, treatment, and blood pressure (BP) control. Sociodemographic and clinical data were collected from a population-based sample of adults ≥18 years in Port-au-Prince (PAP) from March 2019 to April 2021. HTN was defined as systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg, or use of antihypertensive medication. Screening was defined as ever having had a BP measurement; diagnosis as previously being informed of a HTN diagnosis; treatment as having taken antihypertensives in the past 2 weeks; and controlled as taking antihypertensives and having BP < 140/90 mmHg. Factors associated with attaining each step in the continuum were assessed using Poisson multivariable regressions. Among 2737 participants, 810 (29% age-standardized) had HTN, of whom 97% had been screened, 72% diagnosed, 45% treated, and 13% controlled. There were no significant differences across age groups or sex. Obesity (BMI ≥ 30) was a significant factor associated with receiving treatment compared to normal weight (BMI < 25), with a prevalence ratio (PR) of 1.5 (95% CI 1.1-2.0). Having secondary or higher education was associated with higher likelihood of controlled BP (PR 1.9 [95% CI 1.1-3.3]). In this urban Haitian population, the greatest gaps in HTN care are treatment and control. Targeted interventions are needed to improve these steps, including broader access to affordable treatment, timely distribution of medications, and patient adherence to HTN medication.

Estimated blood pressure trajectories and hypertension patterns among pregnant women living with HIV, Haiti, 2007-2017.

Hypertension in pregnancy is a key driver of mortality and morbidity among Haitian women. HIV infection and treatment may worsen hypertension and increase cardiovascular disease risk. The authors examined blood pressure and hypertension patterns among 1965 women (2306 pregnancies ending in live births) in a prevention of maternal-to-child transmission (PMTCT) program in Port-au-Prince, Haiti, between 2007 and 2017. Hypertension was defined as blood pressure ≥140/90 mm Hg on two consecutive visits. Latent class analysis assessed trajectories of mean arterial pressure (MAP) and multinomial ordinal logistic regression examined factors associated with higher trajectories. Between 2007-2009 and 2013-2016, hypertension at PMTCT entry increased from 1.3% to 3.8% (p = .005), while incidence at any time during PMTCT follow-up increased from 5.0 to 16.1 per 100 person-years (p < .001). Hypertension detected ≤20 weeks and > 20 weeks of gestation (possible gestational hypertension) increased from 1.1% to 3.5% (p = .003) and from 2.3% to 6.9% (p < .001), respectively. Five MAP trajectories ranged from low-stable to high-increasing. In multivariable analysis controlling for history of antiretroviral therapy, age, parity, and weight, program entry in more recent years was associated with greater odds of higher MAP trajectory (adjusted odds ratio for 2013-2016 vs. 2007-2009 = 3.1, 95% confidence interval: 1.7-5.6). The increasing prevalence and incidence of hypertension highlight a need for screening and management prior to PMTCT entry and during follow-up. In a population with limited access to chronic disease care, and where many deliveries occur outside of a clinical setting, the period of PMTCT follow-up represents an opportunity to diagnose and initiate management of preexisting and pregnancy-related hypertension.

Real-world Overall Survival Using Oncology Electronic Health Record Data: Friends of Cancer Research Pilot.

In prior work, Friends of Cancer Research convened multiple data partners to establish standardized definitions for oncology real-world end points derived from electronic health records (EHRs) and claims data. Here, we assessed the performance of real-world overall survival (rwOS) from data sets sourced from EHRs by evaluating the ability of the end point to reflect expected differences from a previous randomized controlled trial across five data sources, after applying inclusion/exclusion criteria. The KEYNOTE-189 clinical trial protocol of platinum doublet chemotherapy (chemotherapy) vs. programmed cell death protein 1 (PD-1) in combination with platinum doublet chemotherapy (PD-1 combination) in first-line nonsquamous metastatic non-small cell lung cancer guided retrospective cohort selection. The Kaplan-Meier product limit estimator was used to calculate 12-month rwOS with 95% confidence intervals (CIs) in each data source. Cox proportional hazards models estimated hazard ratios (HRs) and associated 95% CIs, controlled for prognostic factors. Once the inclusion/exclusion criteria were applied, the five resulting data sets included 155 to 1,501 patients in the chemotherapy cohort and 36 to 405 patients in the PD-1 combination cohort. Twelve-month rwOS ranged from 45% to 58% in the chemotherapy cohort and 44% to 68% in the PD-1 combination cohort. The adjusted HR for death ranged from 0.80 (95% CI: 0.69, 0.93) to 1.15 (95% CI: 0.71, 1.85), controlling for age, gender, performance status, and smoking status. This study yielded insights regarding data capture, including ability of real-world data to precisely identify patient populations and the impact of criteria on end points. Sensitivity analyses could elucidate data set-specific factors that drive results.

The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies.

The purpose of this study was to evaluate the potential collective opportunities and challenges of transforming real-world data (RWD) to real-world evidence for clinical effectiveness by focusing on aligning analytic definitions of oncology end points. Patients treated with a qualifying therapy for advanced non-small cell lung cancer in the frontline setting meeting broad eligibility criteria were included to reflect the real-world population. Although a trend toward improved outcomes in patients receiving PD-(L)1 therapy over standard chemotherapy was observed in RWD analyses, the magnitude and consistency of treatment effect was more heterogeneous than previously observed in controlled clinical trials. The study design and analysis process highlighted the identification of pertinent methodological issues and potential innovative approaches that could inform the development of high-quality RWD studies.

High Lead Exposure Associated With Higher Blood Pressure in Haiti: a Warning Sign for Low-Income Countries.

Cardiovascular disease is the leading cause of death in lower-income countries including Haiti. Environmental lead exposure is associated with high blood pressure and cardiovascular mortality in high-income countries but has not been systematically measured and evaluated as a potential modifiable cardiovascular risk factor in lower-income countries where 6.5 billion people reside. We hypothesized lead exposure is high in urban Haiti and associated with higher blood pressure levels. Blood lead levels were measured in 2504 participants ≥18 years enrolled in a longitudinal population-based cohort study in Port-au-Prince. Lead screening was conducted using LeadCare II (detection limit ≥3.3 µg/dL). Levels below detection were imputed by dividing the level of detection by √2. Associations between lead (quartiles) and systolic blood pressure and diastolic blood pressure were assessed, adjusting for age, sex, obesity, smoking, alcohol, physical activity, income, and antihypertensive medication use. The median age of participants was 40 years and 60.1% were female. The geometric mean blood lead level was 4.73µg/dL, 71.1% had a detectable lead level and 42.3% had a blood lead level ≥5 µg/dL. After multivariable adjustment, lead levels in quartile four (≥6.5 µg/dL) compared with quartile 1 (<3.4 µg/dL) were associated with 2.42 mm Hg (95% CI, 0.36-4.49) higher systolic blood pressure and 1.96 mm Hg (95% CI, 0.56-3.37) higher diastolic blood pressure. In conclusion, widespread environmental lead exposure is evident in urban Haiti, with higher lead levels associated with higher systolic and diastolic blood pressure. Lead is a current and potentially modifiable pollutant in lower-income countries that warrants urgent public health remediation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03892265.

Neighborhood cohesion and violence in Port-au-Prince, Haiti, and their relationship to stress, depression, and hypertension: Findings from the Haiti cardiovascular disease cohort study.

Neighborhood factors have been associated with health outcomes, but this relationship is underexplored in low-income countries like Haiti. We describe perceived neighborhood cohesion and perceived violence using the Neighborhood Collective Efficacy and the City Stress Inventory scores. We hypothesized lower cohesion and higher violence were associated with higher stress, depression, and hypertension. We collected data from a population-based cohort of adults in Port-au-Prince, Haiti between March 2019 to August 2021, including stress (Perceived Stress Scale), depression (PHQ-9), and blood pressure (BP). Hypertension was defined as systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg, or on antihypertensive medications. Covariates that were adjusted for included age, sex, body mass index, smoking, alcohol, physical activity, diet, income, and education, multivariable linear and Poisson regressions assessed the relationship between exposures and outcomes. Among 2,961 adults, 58.0% were female and median age was 40 years (IQR:28-55). Participants reported high cohesion (median 15/25, IQR:14-17) and moderate violence (9/20, IQR:7-11). Stress was moderate (8/16) and 12.6% had at least moderate depression (PHQ-9 ≥ 11). Median systolic BP was 118 mmHg, median diastolic BP 72 mmHg, and 29.2% had hypertension. In regressions, higher violence was associated with higher prevalence ratios of moderate-to-severe depression (Tertile3 vs Tertile1: PR 1.12, 95%CI:1.09 to 1.16) and stress (+0.3 score, 95%CI:0.01 to 0.6) but not hypertension. Cohesion was associated with lower stress (Tertile3 vs Tertile1: -0.4 score, 95%CI: -0.7 to -0.2) but not depression or hypertension. In summary, urban Haitians reported high perceived cohesion and moderate violence, with higher violence associated with higher stress and depression.

Characterization of a Real-World Response Variable and Comparison with RECIST-Based Response Rates from Clinical Trials in Advanced NSCLC.

INTRODUCTION: Effectiveness metrics for real-word research, analogous to clinical trial ones, are needed. This study aimed to develop a real-world response (rwR) variable applicable to solid tumors and to evaluate its clinical relevance and meaningfulness. METHODS: This retrospective study used patient cohorts with advanced non-small cell lung cancer from a nationwide, de-identified electronic health record (EHR)-derived database. Disease burden information abstracted manually was classified into response categories anchored to discrete therapy lines (per patient-line). In part 1, we quantified the feasibility and reliability of data capture, and estimated the association between rwR status and real-world progression-free survival (rwPFS) and real-world overall survival (rwOS). In part 2, we investigated the correlation between published clinical trial overall response rates (ORRs) and real-world response rates (rwRRs) from corresponding real-world patient cohorts. RESULTS: In part 1, 85.4% of patients (N = 3248) had at least one radiographic assessment documented. Median abstraction time per patient-line was 15.0 min (IQR 7.8-28.1). Inter-abstractor agreement on presence/absence of at least one assessment was 0.94 (95% CI 0.92-0.96; n = 503 patient-lines abstracted in duplicate); inter-abstractor agreement on best confirmed response category was 0.82 (95% CI 0.78-0.86; n = 384 with at least one captured assessment). Confirmed responders at a 3-month landmark showed significantly lower risk of death and progression in rwOS and rwPFS analyses across all line settings. In part 2, rwRRs (from 12 rw cohorts) showed a high correlation with trial ORRs (Spearman's ρ = 0.99). CONCLUSIONS: We developed a rwR variable generated from clinician assessments documented in EHRs following radiographic evaluations. This variable provides clinically meaningful information and may provide a real-world measure of treatment effectiveness.

Effects of National Adoption of Treat-All Guidelines on Pre-Antiretroviral Therapy (ART) CD4 Testing and Viral Load Monitoring After ART initiation: A Regression Discontinuity Analysis.

BACKGROUND: The World Health Organization's Treat-All guidance recommends CD4 testing before initiating antiretroviral therapy (ART), and routine viral load (VL) monitoring (over CD4 monitoring) for patients on ART. METHODS: We used regression discontinuity analyses to estimate changes in CD4 testing and VL monitoring among 547 837 ART-naive patients enrolling in human immunodeficiency virus (HIV) care during 2006-2018 at 225 clinics in 26 countries where Treat-All policies were adopted. We examined CD4 testing within 12 months before and VL monitoring 6 months after ART initiation among adults (≥20 years), adolescents (10-19 years), and children (0-9 years) in low/lower-middle-income countries (L/LMICs) and high/upper-middle-income countries (H/UMICs). RESULTS: Treat-All adoption led to an immediate decrease in pre-ART CD4 testing among adults in L/LMICs, from 57.0% to 48.1% (-8.9 percentage points [pp]; 95% CI: -11.0, -6.8), and a small increase in H/UMICs, from 90.1% to 91.7% (+1.6pp; 95% CI: 0.2, 3.0), with no changes among adolescents or children; decreases in pre-ART CD4 testing accelerated after Treat-All adoption in L/LMICs. In L/LMICs, VL monitoring after ART initiation was low among all patients in L/LMICs before Treat-All; while there was no immediate change at Treat-All adoption, VL monitoring trends significantly increased afterwards. VL monitoring increased among adults immediately after Treat-All adoption, from 58.2% to 61.1% (+2.9pp; 95% CI: 0.5, 5.4), with no significant changes among adolescents/children. CONCLUSIONS: While on-ART VL monitoring has improved in L/LMICs, Treat-All adoption has accelerated and disparately worsened suboptimal pre-ART CD4 monitoring, which may compromise care outcomes for individuals with advanced HIV.

Tracing-corrected estimates of disengagement from HIV care and mortality among patients enrolling in HIV care without overt immunosuppression in Tanzania.

In the era of "test and treat", it is important to understand HIV care outcomes and their determinants in patients presenting to care with early-stage disease. We surveyed 924 adults newly enrolling in HIV care at four clinics in Tanzania before the adoption of universal treatment eligibility, and collected longitudinal clinical data. Participants who defaulted from care were tracked in the community. Cumulative incidence of disengagement from care and death was estimated using competing risk methods. By 12 months after enrollment, 18.2% of patients had disengaged from care and 6.9% had died. Factors associated with disengagement included male sex (adjusted subhazard ratio [aSHR] versus female = 1.75, 95% confidence interval [CI]: 1.06-2.89), provider-initiated HIV diagnosis (aSHR versus self-referred = 1.71, 95% CI: 1.03-2.86), ineligibility for antiretroviral treatment (ART) at enrollment (aSHR versus eligibility = 2.82, 95% CI: 1.84-4.32) and increased anticipated stigma score (aSHR = 1.04 per 5-point increase, 95% CI: 1.02-1.05). Higher life satisfaction score (aSHR = 0.97 per 5-point increase, 95% CI: 0.95-0.99) and having 1-2 close friends (aSHR versus none = 0.58, 95% CI: 0.47-0.71) were protective. The findings highlight the continued importance of social environment for HIV care outcomes and the potential of universal ART eligibility to reduce HIV care attrition.

The Haiti cardiovascular disease cohort: study protocol for a population-based longitudinal cohort.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality among Haitians, having surpassed HIV in the last decade. Understanding the natural history of CVD in Haitians, including the age of onset, prevalence, incidence, and role of major risk factors and social determinants, is urgently needed to develop prevention and treatment interventions. Aim 1: Establish a population-based cohort of 3000 adults from Port-au-Prince and assess the prevalence of CVD risk factors and diseases and their association with social and environmental determinants. Aim 2: Determine the incidence of CVD risk factors and CVD during 2-3.5 years of follow-up and their association with social and environmental determinants. METHODS: The Haiti CVD Cohort is a longitudinal observational study of 3000 adults > 18 years in Port-au-Prince (PAP), Haiti. The study population is recruited using multistage random sampling from census blocks. Adults receive blood pressure (BP) measurements in the community and those with elevated BP are referred to the Groupe Haitien d'Etude Sarcome de Kaposi et des Infections Opportunistes Clinic for care. After informed consent, participants undergo a clinical exam with medical history. BP, electrocardiogram, echocardiogram, a study questionnaire on health behaviors, and laboratory specimens. Every 6 months, BP is remeasured. At 12 and 24 months, clinical exams and questionnaires are repeated. Labs are repeated at 24 months. Adjudicated study outcomes include the prevalence and incidence of CVD risk factors (hypertension, diabetes, obesity, dyslipidemia, kidney disease, inflammation, poor diet, smoking, and physical inactivity) and events (myocardial infarction, heart failure, stroke, and CVD mortality). We also measure social determinants including poverty. Depression, stress, social isolation, food insecurity, and lead exposure. Blood, urine, and stool samples are biobanked at study enrollment. DISCUSSION: The Haiti CVD Cohort is the largest population-based cohort study evaluating CVD risk factors and CVD among adults in urban Haiti with the goal of understanding the drivers of the CVD epidemic in Haiti. Study outcomes are comparable with existing international cohorts, and the biobank will provide important data for future research. Our goal is to translate findings from this study into pragmatic prevention and treatment interventions to fight the CVD epidemic in Haiti.

Gone But Not Lost: Implications for Estimating HIV Care Outcomes When Loss to Clinic Is Not Loss to Care.

BACKGROUND: In some time-to-event analyses, it is unclear whether loss to follow up should be treated as a censoring event or competing event. Such ambiguity is particularly common in HIV research that uses routinely collected clinical data to report the timing of key milestones along the HIV care continuum. In this setting, loss to follow up may be viewed as a censoring event, under the assumption that patients who are "lost" from a study clinic immediately enroll in care elsewhere, or a competing event, under the assumption that people "lost" are out of care all together. METHODS: We illustrate an approach to address this ambiguity when estimating the 2-year risk of antiretroviral treatment initiation among 19,506 people living with HIV who enrolled in the IeDEA Central Africa cohort between 2006 and 2017, along with published estimates from tracing studies in Africa. We also assessed the finite sample properties of the proposed approach using simulation experiments. RESULTS: The estimated 2-year risk of treatment initiation was 69% if patients were censored at loss to follow up or 59% if losses to follow up were treated as competing events. Using the proposed approach, we estimated that the 2-year risk of antiretroviral therapy initiation was 62% (95% confidence interval: 61, 62). The proposed approach had little bias and appropriate confidence interval coverage under scenarios examined in the simulation experiments. CONCLUSIONS: The proposed approach relaxes the assumptions inherent in treating loss to follow up as a censoring or competing event in clinical HIV cohort studies.

Gender, HIV-Related Stigma, and Health-Related Quality of Life Among Adults Enrolling in HIV Care in Tanzania.

HIV-related stigma has been associated with worse health-related quality of life (HRQoL) among people living with HIV (PLWH). Little is known about how different types of HIV-related stigma (i.e., anticipatory, internalized, or enacted HIV-related stigma) influence HRQoL and whether these relationships differ by gender. The sample included 912 PLWH aged 18 years or older enrolling in HIV care at four health facilities in Tanzania. HRQoL was assessed with the life satisfaction and overall function subscales of the HIV/AIDS-Targeted Quality of Life (HAT-QoL) instrument. Sex-stratified multivariable logistic regression modeled the association of anticipatory, internalized, and enacted HIV-related stigma on poor HRQoL. Across all participants, the mean life satisfaction score was 63.4 (IQR: 43.8, 81.3) and the mean overall function score was 72.0 (IQR: 58.3, 91.7). Mean HRQoL scores were significantly higher for women compared to men for overall function (5.1 points higher) and life satisfaction (4.3 points higher). Fourteen percent of respondents reported recent enacted HIV-related stigma and 13% reported recent medium or high levels of internalized stigma. In multivariable models, high internalized and high anticipatory stigma were significantly associated with higher odds of poor life satisfaction and poor overall function in both men and women. Psychosocial interventions to prevent or reduce the impact of internalized and anticipatory stigma may improve HRQoL among persons in HIV care. Future research should longitudinally examine mechanisms between HIV-related stigma, poor HRQoL, and HIV care outcomes.

Psychological distress among a population-representative sample of residents of four slum neighborhoods in Port-au-Prince, Haiti.

BACKGROUND: Almost one billion people live in slum environments across low- and middle-income countries. Little is known about the mental health status of slum residents or its associations with living conditions. METHODS: A cross-sectional, population-representative survey was conducted among 892 adults in four slum communities in Port-au-Prince. Psychological distress was assessed with the Kessler Psychological Distress Scale (K-6). Log-binomial regression modeled the association of sociodemographic variables, living conditions, and material hardship and severe psychological distress [SPD]. RESULTS: Eighty-six percent of adults reported psychological distress (24% severe and 62% moderate). Reliance on an outdoor drinking water source (versus bottled water) and a pit toilet (versus a flush toilet) were marginally positively associated with SPD (adjusted prevalence ratio [aPR]=1.42, 95% confidence interval [CI]: 1.00-2.02 and aPR=1.74, 95% CI: 0.96-3.15, respectively). The prevalence of SPD was higher among women (versus men, aPR=1.66, 95% CI: 1.26-2.19), residents who had foregone healthcare to afford food (versus those who had never done so, aPR=1.60, 95% CI: 1.16-2.45), and persons who drank alcohol at least twice a week (versus monthly or less, aPR=1.73, 95% CI: 1.22-2.45). LIMITATIONS: Data were cross-sectional and lacked information on potential risk factors such as exposure to trauma. CONCLUSIONS: Psychological distress was highly prevalent and associated with poor living conditions. Prospective studies on the mechanisms through which slum living conditions are associated with psychological distress are needed. Research should also assess the feasibility and acceptability of implementation strategies to increase access to mental health screening and treatment for slum residents.

Impact of Universal Antiretroviral Treatment Eligibility on Rapid Treatment Initiation Among Young Adolescents with Human Immunodeficiency Virus in Sub-Saharan Africa.

BACKGROUND: Young adolescents with perinatally acquired human immunodeficiency virus (HIV) are at risk for poor care outcomes. We examined whether universal antiretroviral treatment (ART) eligibility policies (Treat All) improved rapid ART initiation after care enrollment among 10-14-year-olds in 7 sub-Saharan African countries. METHODS: Regression discontinuity analysis and data for 6912 patients aged 10-14-years were used to estimate changes in rapid ART initiation (within 30 days of care enrollment) after adoption of Treat All policies in 2 groups of countries: Uganda and Zambia (policy adopted in 2013) and Burundi, Democratic Republic of the Congo, Kenya, Malawi, and Rwanda (policy adopted in 2016). RESULTS: There were immediate increases in rapid ART initiation among young adolescents after national adoption of Treat All. Increases were greater in countries adopting the policy in 2016 than in those adopting it in 2013: 23.4 percentage points (pp) (95% confidence interval, 13.9-32.8) versus 11.2pp (2.5-19.9). However, the rate of increase in rapid ART initiation among 10-14-year-olds rose appreciably in countries with earlier treatment expansions, from 1.5pp per year before Treat All to 7.7pp per year afterward. CONCLUSIONS: Universal ART eligibility has increased rapid treatment initiation among young adolescents enrolling in HIV care. Further research should assess their retention in care and viral suppression under Treat All.

Implementation of "Treat-all" at adult HIV care and treatment sites in the Global IeDEA Consortium: results from the Site Assessment Survey.

INTRODUCTION: Since 2015, the World Health Organization (WHO) has recommended that all people living with HIV (PLHIV) initiate antiretroviral treatment (ART), irrespective of CD4+ count or clinical stage. National adoption of universal treatment has accelerated since WHO's 2015 "Treat All" recommendation; however, little is known about the translation of this guidance into practice. This study aimed to assess the status of Treat All implementation across regions, countries, and levels of the health care delivery system. METHODS: Between June and December 2017, 201/221 (91%) adult HIV treatment sites that participate in the global IeDEA research consortium completed a survey on capacity and practices related to HIV care. Located in 41 countries across seven geographic regions, sites provided information on the status and timing of site-level introduction of Treat All, as well as site-level practices related to ART initiation. RESULTS: Almost all sites (93%) reported that they had begun implementing Treat All, and there were no statistically significant differences in site-level Treat All introduction by health facility type, urban/rural location, sector (public/private) or country income level. The median time between national policy adoption and site-level introduction was one month. In countries where Treat All was not yet adopted in national guidelines, 69% of sites reported initiating all patients on ART, regardless of clinical criteria, and these sites had been implementing Treat All for a median period of seven months at the time of the survey. The majority of sites (77%) reported typically initiating patients on ART within 14 days of confirming diagnosis, with 60% to 62% of sites implementing Treat All in East, Southern and West Africa reporting same-day ART initiation for most patients. CONCLUSIONS: By mid- to late-2017, the Treat All strategy was the standard of care at almost all IeDEA sites, including rural, primary-level health facilities in low-resource settings. While further assessments of site-level capacity to provide high-quality HIV care under Treat All and to support sustained viral suppression after ART initiation are needed, the widespread introduction of Treat All at the service delivery level is a critical step towards global targets for ending the HIV epidemic as a public health threat.

Changes in rapid HIV treatment initiation after national "treat all" policy adoption in 6 sub-Saharan African countries: Regression discontinuity analysis.

BACKGROUND: Most countries have formally adopted the World Health Organization's 2015 recommendation of universal HIV treatment ("treat all"). However, there are few rigorous assessments of the real-world impact of treat all policies on antiretroviral treatment (ART) uptake across different contexts. METHODS AND FINDINGS: We used longitudinal data for 814,603 patients enrolling in HIV care between 1 January 2004 and 10 July 2018 in 6 countries participating in the global International epidemiology Databases to Evaluate AIDS (IeDEA) consortium: Burundi (N = 11,176), Kenya (N = 179,941), Malawi (N = 84,558), Rwanda (N = 17,396), Uganda (N = 96,286), and Zambia (N = 425,246). Using a quasi-experimental regression discontinuity design, we assessed the change in the proportion initiating ART within 30 days of enrollment in HIV care (rapid ART initiation) after country-level adoption of the treat all policy. A modified Poisson model was used to identify factors associated with failure to initiate ART rapidly under treat all. In each of the 6 countries, over 60% of included patients were female, and median age at enrollment ranged from 32 to 36 years. In all countries studied, national adoption of treat all was associated with large increases in rapid ART initiation. Significant increases in rapid ART initiation immediately after treat all policy adoption were observed in Rwanda, from 44.4% to 78.9% of patients (34.5 percentage points [pp], 95% CI 27.2 to 41.7; p < 0.001), Kenya (25.7 pp, 95% CI 21.8 to 29.5; p < 0.001), Burundi (17.7 pp, 95% CI 6.5 to 28.9; p = 0.002), and Malawi (12.5 pp, 95% CI 7.5 to 17.5; p < 0.001), while no immediate increase was observed in Zambia (0.4 pp, 95% CI -2.9 to 3.8; p = 0.804) and Uganda (-4.2 pp, 95% CI -9.0 to 0.7; p = 0.090). The rate of rapid ART initiation accelerated sharply following treat all policy adoption in Malawi, Uganda, and Zambia; slowed in Kenya; and did not change in Rwanda and Burundi. In post hoc analyses restricted to patients enrolling under treat all, young adults (16-24 years) and men were at increased risk of not rapidly initiating ART (compared to older patients and women, respectively). However, rapid ART initiation following enrollment increased for all groups as more time elapsed since treat all policy adoption. Study limitations include incomplete data on potential ART eligibility criteria, such as clinical status, pregnancy, and enrollment CD4 count, which precluded the assessment of rapid ART initiation specifically among patients known to be eligible for ART before treat all. CONCLUSIONS: Our analysis indicates that adoption of treat all policies had a strong effect on increasing rates of rapid ART initiation, and that these increases followed different trajectories across the 6 countries. Young adults and men still require additional attention to further improve rapid ART initiation.