The Epidemiology of Long Coronavirus Disease in US Adults.

BACKGROUND: We estimated the prevalence of long COVID and impact on daily living among a representative sample of adults in the United States. METHODS: We conducted a population-representative survey, 30 June-2 July 2022, of a random sample of 3042 US adults aged 18 years or older and weighted to the 2020 US population. Using questions developed by the UK's Office of National Statistics, we estimated the prevalence of long COVID, by sociodemographics, adjusting for gender and age. RESULTS: An estimated 7.3% (95% confidence interval: 6.1-8.5%) of all respondents reported long COVID, corresponding to approximately 18 828 696 adults. One-quarter (25.3% [18.2-32.4%]) of respondents with long COVID reported their day-to-day activities were impacted "a lot" and 28.9% had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection more than 12 months ago. The prevalence of long COVID was higher among respondents who were female (adjusted prevalence ratio [aPR]: 1.84 [1.40-2.42]), had comorbidities (aPR: 1.55 [1.19-2.00]), or were not (vs were) boosted (aPR: 1.67 [1.19-2.34]) or not vaccinated (vs boosted) (aPR: 1.41 [1.05-1.91]). CONCLUSIONS: We observed a high burden of long COVID, substantial variability in prevalence of SARS-CoV-2, and risk factors unique from SARS-CoV-2 risk, suggesting areas for future research. Population-based surveys are an important surveillance tool and supplement to ongoing efforts to monitor long COVID.

Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti.

BACKGROUND: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population. METHODS AND FINDINGS: We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov NCT03154320.

The prevalence of SARS-CoV-2 infection and long COVID in U.S. adults during the BA.4/BA.5 surge, June-July 2022.

Due to changes in SARS-CoV-2 testing practices, passive case-based surveillance may be an increasingly unreliable indicator for monitoring the burden of SARS-CoV-2, especially during surges. We conducted a cross-sectional survey of a population-representative sample of 3042 U.S. adults between June 30 and July 2, 2022, during the Omicron BA.4/BA.5 surge. Respondents were asked about SARS-CoV-2 testing and outcomes, COVID-like symptoms, contact with cases, and experience with prolonged COVID-19 symptoms following prior infection. We estimated the weighted age and sex-standardized SARS-CoV-2 prevalence, during the 14-day period preceding the interview. We estimated age and gender adjusted prevalence ratios (aPR) for current SARS-CoV-2 infection using a log-binomial regression model. An estimated 17.3% (95% CI 14.9, 19.8) of respondents had SARS-CoV-2 infection during the two-week study period-equating to 44 million cases as compared to 1.8 million per the CDC during the same time period. SARS-CoV-2 prevalence was higher among those 18-24 years old (aPR 2.2, 95% CI 1.8, 2.7) and among non-Hispanic Black (aPR 1.7, 95% CI 1.4,2.2) and Hispanic adults (aPR 2.4, 95% CI 2.0, 2.9). SARS-CoV-2 prevalence was also higher among those with lower income (aPR 1.9, 95% CI 1.5, 2.3), lower education (aPR 3.7 95% CI 3.0,4.7), and those with comorbidities (aPR 1.6, 95% CI 1.4, 2.0). An estimated 21.5% (95% CI 18.2, 24.7) of respondents with a SARS-CoV-2 infection >4 weeks prior reported long COVID symptoms. The inequitable distribution of SARS-CoV-2 prevalence during the BA.4/BA.5 surge will likely drive inequities in the future burden of long COVID.

Health Status, Persistent Symptoms, and Effort Intolerance One Year After Acute COVID-19 Infection.

BACKGROUND: The long-term prevalence and risk factors for post-acute COVID-19 sequelae (PASC) are not well described and may have important implications for unvaccinated populations and policy makers. OBJECTIVE: To assess health status, persistent symptoms, and effort tolerance approximately 1 year after COVID-19 infection DESIGN: Retrospective observational cohort study using surveys and clinical data PARTICIPANTS: Survey respondents who were survivors of acute COVID-19 infection requiring Emergency Department presentation or hospitalization between March 3 and May 15, 2020. MAIN MEASURE(S): Self-reported health status, persistent symptoms, and effort tolerance KEY RESULTS: The 530 respondents (median time between hospital presentation and survey 332 days [IQR 325-344]) had mean age 59.2±16.3 years, 44.5% were female and 70.8% were non-White. Of these, 41.5% reported worse health compared to a year prior, 44.2% reported persistent symptoms, 36.2% reported limitations in lifting/carrying groceries, 35.5% reported limitations climbing one flight of stairs, 38.1% reported limitations bending/kneeling/stooping, and 22.1% reported limitations walking one block. Even those without high-risk comorbid conditions and those seen only in the Emergency Department (but not hospitalized) experienced significant deterioration in health, persistent symptoms, and limitations in effort tolerance. Women (adjusted relative risk ratio [aRRR] 1.26, 95% CI 1.01-1.56), those requiring mechanical ventilation (aRRR 1.48, 1.02-2.14), and people with HIV (aRRR 1.75, 1.14-2.69) were significantly more likely to report persistent symptoms. Age and other risk factors for more severe COVID-19 illness were not associated with increased risk of PASC. CONCLUSIONS: PASC may be extraordinarily common 1 year after COVID-19, and these symptoms are sufficiently severe to impact the daily exercise tolerance of patients. PASC symptoms are broadly distributed, are not limited to one specific patient group, and appear to be unrelated to age. These data have implications for vaccine hesitant individuals, policy makers, and physicians managing the emerging longer-term yet unknown impact of the COVID-19 pandemic.

Point-of-care viral load testing among adolescents and young adults living with HIV in Haiti: a randomized control trial.

HIV viral load (VL) monitoring can reinforce antiretroviral therapy (ART) adherence. Standard VL testing requires high laboratory capacity and coordination between clinic and laboratory which can delay results. A randomized trial comparing point-of-care (POC) VL testing to standard VL testing among 150 adolescents and young adults, ages 10-24 years, living with HIV in Haiti determined if POC VL testing could return faster results and improve ART adherence and viral suppression. Participants received a POC VL test with same-day result (POC arm) or a standard VL test with result given 1 month later (SOC arm). POC arm participants were more likely to receive a test result within 6 weeks than SOC arm participants (94.7% vs. 80.1%; p1000 copies/ml and low self-reported ART adherence was stronger in the POC arm (OR: 6.57; 95%CI: 2.12-25.21) than the SOC arm (OR: 2.62; 95%CI: 0.97-7.44) suggesting more accurate self-report in the POC arm. POC VL testing was effectively implemented in this low-resource setting with faster results and is a pragmatic intervention that may enable clinicians to identify those with high VL to provide enhanced counseling or regimen changes sooner.Trial registration: ClinicalTrials.gov identifier: NCT03288246.

Comparing six cardiovascular risk prediction models in Haiti: implications for identifying high-risk individuals for primary prevention.

BACKGROUND: Cardiovascular diseases (CVD) are rapidly increasing in low-middle income countries (LMICs). Accurate risk assessment is essential to reduce premature CVD by targeting primary prevention and risk factor treatment among high-risk groups. Available CVD risk prediction models are built on predominantly Caucasian risk profiles from high-income country populations, and have not been evaluated in LMIC populations. We aimed to compare six existing models for predicted 10-year risk of CVD and identify high-risk groups for targeted prevention and treatment in Haiti. METHODS: We used cross-sectional data within the Haiti CVD Cohort Study, including 1345 adults ≥ 40 years without known history of CVD and with complete data. Six CVD risk prediction models were compared: pooled cohort equations (PCE), adjusted PCE with updated cohorts, Framingham CVD Lipids, Framingham CVD Body Mass Index (BMI), WHO Lipids, and WHO BMI. Risk factors were measured during clinical exams. Primary outcome was continuous and categorical predicted 10-year CVD risk. Secondary outcome was statin eligibility. RESULTS: Sixty percent were female, 66.8% lived on a daily income of ≤ 1 USD, 52.9% had hypertension, 14.9% had hypercholesterolemia, 7.8% had diabetes mellitus, 4.0% were current smokers, and 2.5% had HIV. Predicted 10-year CVD risk ranged from 3.6% in adjusted PCE (IQR 1.7-8.2) to 9.6% in Framingham-BMI (IQR 4.9-18.0), and Spearman rank correlation coefficients ranged from 0.86 to 0.98. The percent of the cohort categorized as high risk using model specific thresholds ranged from 1.8% using the WHO-BMI model to 41.4% in the PCE model (χ2 = 1416, p value < 0.001). Statin eligibility also varied widely. CONCLUSIONS: In the Haiti CVD Cohort, there was substantial variation in the proportion identified as high-risk and statin eligible using existing models, leading to very different treatment recommendations and public health implications depending on which prediction model is chosen. There is a need to design and validate CVD risk prediction tools for low-middle income countries that include locally relevant risk factors. TRIAL REGISTRATION: clinicaltrials.gov NCT03892265 .

Human Immunodeficiency Virus-Associated Myocardial Diastolic Dysfunction and Soluble ST2 Concentration in Tanzanian Adults: A Cross-Sectional Study.

BACKGROUND: The aims of this study were (1) to compare the prevalence of myocardial diastolic dysfunction (DD) in antiretroviral therapy (ART)-naive people living with human immunodeficiency virus (PLWH) to human immunodeficiency virus (HIV)-uninfected adults in East Africa and (2) to determine the association between serum concentration of the cardiac biomarkers ST2 and DD. METHODS: In this cross-sectional study, we enrolled PLWH and uninfected adults at a referral HIV clinic in Mwanza, Tanzania. Standardized history, echocardiography, and serum were obtained. Regression models were used to quantify associations. RESULTS: We enrolled 388 ART-naive PLWH and 461 HIV-uninfected adults with an average age of 36.0 ± 10.2 years. Of PLWH in the third, fourth, and fifth decades of life, 5.0%, 12.5%, and 32.7%, respectively, had DD. PLWH had a higher prevalence of DD (adjusted odds ratio, 2.71 [95% confidence interval, 1.62-4.55]; P < .0001). PLWH also had a higher probability of dysfunction with one or fewer traditional risk factors present. Serum ST2 concentration was associated with dysfunction in PLWH but not uninfected participants (P = .04 and P = .90, respectively). CONCLUSIONS: In a large population of young adults in sub-Saharan Africa, DD prevalence increased starting in the third decade of life. HIV was independently associated with dysfunction. Serum ST2 concentration was associated with DD in PLWH but not HIV-uninfected participants. This pathway may provide insight into the mechanisms of HIV-associated dysfunction.

The Virtual Hospitalist: a Critical Innovation During the COVID-19 Crisis.

A virtual hospitalist program expanded our ability to confront the challenges of the COVID-19 crisis at the epicenter of the pandemic in New York City. In concert with on-site hospitalists and redeployed physicians, virtual hospitalists aimed to expand capacity while maintaining high-quality care and communication. The program addressed multiple challenges created by our first COVID-19 surge: high patient census and acuity; limitations of and due to personal protective equipment; increased communication needs due to visitor restrictions and the uncertain nature of the novel disease, and limitations to in-person work for some physicians. The program created a mechanism to train and support new hospitalists and provide and expand palliative care services. We describe how our virtual hospitalist program operated during our COVID-19 surge in April and May 2020 and reflect on potential roles of virtual hospitalists after the COVID-19 crisis passes.

Thirty-Day Post-Discharge Outcomes Following COVID-19 Infection.

BACKGROUND: The clinical course of COVID-19 includes multiple disease phases. Data describing post-hospital discharge outcomes may provide insight into disease course. Studies describing post-hospitalization outcomes of adults following COVID-19 infection are limited to electronic medical record review, which may underestimate the incidence of outcomes. OBJECTIVE: To determine 30-day post-hospitalization outcomes following COVID-19 infection. DESIGN: Retrospective cohort study SETTING: Quaternary referral hospital and community hospital in New York City. PARTICIPANTS: COVID-19 infected patients discharged alive from the emergency department (ED) or hospital between March 3 and May 15, 2020. MEASUREMENT: Outcomes included return to an ED, re-hospitalization, and mortality within 30 days of hospital discharge. RESULTS: Thirty-day follow-up data were successfully collected on 94.6% of eligible patients. Among 1344 patients, 16.5% returned to an ED, 9.8% were re-hospitalized, and 2.4% died. Among patients who returned to the ED, 50.0% (108/216) went to a different hospital from the hospital of the index presentation, and 61.1% (132/216) of those who returned were re-hospitalized. In Cox models adjusted for variables selected using the lasso method, age (HR 1.01 per year [95% CI 1.00-1.02]), diabetes (1.54 [1.06-2.23]), and the need for inpatient dialysis (3.78 [2.23-6.43]) during the index presentation were independently associated with a higher re-hospitalization rate. Older age (HR 1.08 [1.05-1.11]) and Asian race (2.89 [1.27-6.61]) were significantly associated with mortality. CONCLUSIONS: Among patients discharged alive following their index presentation for COVID-19, risk for returning to a hospital within 30 days of discharge was substantial. These patients merit close post-discharge follow-up to optimize outcomes.

Searching for Human Connectedness During COVID-19.

The COVID-19 pandemic has fundamentally transformed doctor-patient communication, stripping away moments of connection that define the humanism of medicine. The barrier of isolation has impacted patients and patient care, and has also affected the experience of the physician. Though in-person connection is impossible to replicate digitally, technology has restored some sense of togetherness.

Interventions to Improve Antiretroviral Therapy Adherence Among Adolescents and Youth in Low- and Middle-Income Countries: A Systematic Review 2015-2019.

Adolescents and youth living with HIV have poorer antiretroviral treatment (ART) adherence and viral suppression outcomes than all other age groups. Effective interventions promoting adherence are urgently needed. We reviewed and synthesized recent literature on interventions to improve ART adherence among this vulnerable population. We focus on studies conducted in low- and middle-income countries (LMIC) where the adolescent and youth HIV burden is greatest. Articles published between September 2015 and January 2019 were identified through PubMed. Inclusion criteria were: [1] included participants ages 10-24 years; [2] assessed the efficacy of an intervention to improve ART adherence; [3] reported an ART adherence measurement or viral load; [4] conducted in a LMIC. Articles were reviewed for study population characteristics, intervention type, study design, outcomes measured, and intervention effect. Strength of each study's evidence was evaluated according to an adapted World Health Organization GRADE system. Articles meeting all inclusion criteria except being conducted in an LMIC were reviewed for results and potential transportability to a LMIC setting. Of 108 articles identified, 7 met criteria for inclusion. Three evaluated patient-level interventions and four evaluated health services interventions. Of the patient-level interventions, two were experimental designs and one was a retrospective cohort study. None of these interventions improved ART adherence or viral suppression. Of the four health services interventions, two targeted stable patients and reduced the amount of time spent in the clinic or grouped patients together for bi-monthly meetings, and two targeted patients newly diagnosed with HIV or not yet deemed clinically stable and augmented clinical care with home-based case-management. The two studies targeting stable patients used retrospective cohort designs and found that adolescents and youth were less likely to maintain viral suppression than children or adults. The two studies targeting patients not yet deemed clinically stable included one experimental and one retrospective cohort design and showed improved ART adherence and viral suppression outcomes. ART adherence and viral suppression outcomes remain a major challenge among adolescents and youth. Intensive home-based case management models of care hold promise for improving outcomes in this population and warrant further research.

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.

High Burden of Non-communicable Diseases among a Young Slum Population in Haiti.

The objective of this study was to characterize the demographics and population health of four slum communities in Port-au-Prince, Haiti, including population density and the burden of communicable and non-communicable diseases. Four urban slums were surveyed using a population-representative design between July and October 2016. A multistage cluster area random sampling process was used to identify households and individuals for the survey. Household surveys included rosters of residents, household characteristics, adult and child deaths in the past year, child health, and healthcare access and utilization. Individual surveys of two randomly sampled adults from each household included sociodemographic data, maternal health, and adult health. Additionally, blood pressure, height, weight, and psychological distress were measured by study staff. Data were weighted for complex survey design and non-response. A total of 525 households and 894 individuals completed the survey (96% household and 90% individual response rate, respectively). The estimated population density was 58,000 persons/km2. Across slums, 55% of all residents were female, and 38% were adolescents and youth 10-24 years. Among adults, 58% were female with median age 29 years (22-38). The most common adult illnesses were severe psychological distress (24%), hypertension (20%), history of physical injury/trauma (10%), asthma (7%), history of cholera (4%), and history of tuberculosis (3%). Ten percent of adults had obesity (BMI > 30 kg/m2), and 7% currently smoked. The most common under-5 diseases during the last 3 months were respiratory and gastrointestinal illnesses (50% and 28%, respectively). One-third of households reported needing medical care for a child in the past year but not being able to access it, largely due to financial constraints. Unique features of these slums are a population structure dominated by adolescents and youth, a high proportion of females, and a high burden of non-communicable diseases including hypertension and psychological distress. Screening, diagnostic, and disease management interventions are urgently needed to protect and promote improved population health outcomes in these slum communities.

Low rates of prior HIV testing among HIV-positive adults accessing outpatient services in Eswatini.

Prior HIV testing and awareness of HIV-positive status were assessed among HIV-positive adults at 20 clinics in Eswatini. Of 2196 HIV-positive adults, 1183 (53.8%) reported no prior HIV testing, and 1948 (88.7%) were unaware of their HIV-positive status. Males [adjusted odds ratio, AOR, (95% confidence interval): 0.7 (0.5-0.9)], youth 18-25 years [AOR 0.6 (0.4-0.95)], adults ≥ 50 years [AOR 0.5 (0.3-0.9)], those needing family support [AOR 0.6 (0.5-0.8)], and those living ≥ 45 min from clinic [AOR 0.5 (0.4-0.8)] were less likely to know their HIV-positive status. More HIV testing is needed to achieve 95-95-95 targets, with targeted strategies for those less likely to test for HIV.

The FANMI ("my FAMILY" in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial.

BACKGROUND: Adolescent girls and young women living with HIV in resource-limited settings have the poorest health outcomes of any age group, due in part to poor retention in care. Differentiated models of HIV care that target the specific challenges of young people living with HIV are urgently needed. METHODS: The FANMI study is an unblinded randomized controlled trial designed to evaluate the efficacy of an adolescent-specific model of HIV care in Port-au-Prince, Haiti. The FANMI intervention places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location. In contrast, participants in the standard care arm receive routine HIV care and individual counseling each month in GHESKIO's Adolescent Clinic. A total of 160 participants ages 16-23 years old are being randomized on a 1:1 basis. The primary outcome is retention in HIV care defined as being alive and in care at 12 months after enrollment. Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs. DISCUSSION: The FANMI study evaluates a novel community-based cohort model of HIV care aimed at improving retention in care and reducing risk behaviors for HIV transmission among adolescent girls and young women living with HIV. Specifically, the FANMI model of care addresses social isolation by placing participants in cohorts of 5-10 peers to provide intensified peer support and makes HIV health management a group norm; reduces stigma and improves convenience by providing care in a community setting; and integrates clinical care and social support by the same providers to streamline care and promote long-term patient-provider relationships. If shown to be effective, the FANMI intervention may serve as a model of HIV care for improving retention among hard-to-reach adolescents and young adults in Haiti and could be adapted for other high-risk groups globally. TRIAL REGISTRATION: Identifier: NCT03286504, Registered September 18, 2017.

Fifteen years of HIV and syphilis outcomes among a prevention of mother-to-child transmission program in Haiti: from monotherapy to Option B.

OBJECTIVE: To evaluate mother and infant outcomes in the largest prevention of mother-to-child-transmission (PMTCT) programme in Haiti in order to identify gaps towards elimination of HIV and syphilis. METHODS: Based on retrospective data from HIV+ pregnant women and their infants enrolled in PMTCT care from 1999 to 2014, we assessed maternal enrolment in PMTCT, receipt of antiretrovirals before delivery, maternal retention through delivery as well as infant enrolment in PMTCT, HIV testing and HIV infection. Four PMTCT programme periods were compared: period 1 (1999-2004, mono ARV), period 2 (2005-2009, dual ARV), period 3 (2010-2012, Option B) and period 4 (Oct 2012-2014, Option B+). Kaplan-Meier methods were used to assess retention in PMTCT care. RESULTS: Among 4665 pregnancies, median age was 27 years and median CD4+ was 494 cells/µl (IQR 328-691). A total of 75% of women received antiretrovirals before delivery, and 73% were retained in care through delivery. Twenty-two percent of women were lost before delivery, <1% died and 6% had stillbirths or abortions. Ninety-four percent of infants who were born alive enrolled in PMTCT, of whom 92% had complete HIV testing. One hundred and sixty-one infants were HIV+, giving a 5.4% HIV transmission rate (9.8%, 4.6%, 5.8% and 3.6% in periods 1-4). Retention among women through 12 months after PMTCT enrolment did not significantly differ across periods. However, among women who received antiretrovirals at the time of enrolment, retention 12 months later was lower in the Option B+ period (83%) than in periods 2 and 3 (94% and 93%) (P < 0.001). Syphilis infection among women decreased from 16% in period 1 to 8% in period 4, whereas syphilis testing of infants increased from 17% to 91%. CONCLUSION: Despite dramatic reductions in MTCT in Haiti, interventions are needed to improve retention to achieve MTCT elimination of HIV and syphilis.

Treating loss-to-follow-up as a missing data problem: a case study using a longitudinal cohort of HIV-infected patients in Haiti.

BACKGROUND: HIV programs are often assessed by the proportion of patients who are alive and retained in care; however some patients are categorized as lost to follow-up (LTF) and have unknown vital status. LTF is not an outcome but a mixed category of patients who have undocumented death, transfer and disengagement from care. Estimating vital status (dead versus alive) among this category is critical for survival analyses and program evaluation. METHODS: We used three methods to estimate survival in the cohort and to ascertain factors associated with death among the first cohort of HIV positive patients to receive antiretroviral therapy in Haiti: complete case (CC) (drops missing), Inverse Probability Weights (IPW) (uses tracking data) and Multiple Imputation with Chained Equations (MICE) (imputes missing data). Logistic regression was used to calculate odds ratios and 95% confidence intervals for adjusted models for death at 10 years. The logistic regression models controlled for sex, age, severe poverty (living on <$1 USD per day), Port-au-Prince residence and baseline clinical characteristics of weight, CD4, WHO stage and tuberculosis diagnosis. RESULTS: Age, severe poverty, baseline weight and WHO stage were statistically significant predictors of AIDS related mortality across all models. Gender was only statistically significant in the MICE model but had at least a 10% difference in odds ratios across all models. CONCLUSION: Each of these methods had different assumptions and differed in the number of observations included due to how missing values were addressed. We found MICE to be most robust in predicting survival status as it allowed us to impute missing data so that we had the maximum number of observations to perform regression analyses. MICE also provides a complementary alternative for estimating survival among patients with unassigned vital status. Additionally, the results were easier to interpret, less likely to be biased and provided an alternative to a problem that is often commented upon in the extant literature.

Clinical decision tools are needed to identify HIV-positive patients at high risk for poor outcomes after initiation of antiretroviral therapy.

Margaret McNairy and colleagues highlight the need for clinical decision tools to help identify HIV patients who would benefit from tailored services to avoid poor outcomes such as death and loss to follow-up.

Effectiveness of a combination strategy for linkage and retention in adult HIV care in Swaziland: The Link4Health cluster randomized trial.

BACKGROUND: Gaps in the HIV care continuum contribute to poor health outcomes and increase HIV transmission. A combination of interventions targeting multiple steps in the continuum is needed to achieve the full beneficial impact of HIV treatment. METHODS AND FINDINGS: Link4Health, a cluster-randomized controlled trial, evaluated the effectiveness of a combination intervention strategy (CIS) versus the standard of care (SOC) on the primary outcome of linkage to care within 1 month plus retention in care at 12 months after HIV-positive testing. Ten clusters of HIV clinics in Swaziland were randomized 1:1 to CIS versus SOC. The CIS included point-of-care CD4+ testing at the time of an HIV-positive test, accelerated antiretroviral therapy (ART) initiation for treatment-eligible participants, mobile phone appointment reminders, health educational packages, and noncash financial incentives. Secondary outcomes included each component of the primary outcome, mean time to linkage, assessment for ART eligibility, ART initiation and time to ART initiation, viral suppression defined as HIV-1 RNA < 1,000 copies/mL at 12 months after HIV testing among patients on ART ≥6 months, and loss to follow-up and death at 12 months after HIV testing. A total of 2,197 adults aged ≥18 years, newly tested HIV positive, were enrolled from 19 August 2013 to 21 November 2014 (1,096 CIS arm; 1,101 SOC arm) and followed for 12 months. The median participant age was 31 years (IQR 26-39), and 59% were women. In an intention-to-treat analysis, 64% (705/1,096) of participants at the CIS sites achieved the primary outcome versus 43% (477/1,101) at the SOC sites (adjusted relative risk [RR] 1.52, 95% CI 1.19-1.96, p = 0.002). Participants in the CIS arm versus the SOC arm had the following secondary outcomes: linkage to care regardless of retention at 12 months (RR 1.08, 95% CI 0.97-1.21, p = 0.13), mean time to linkage (2.5 days versus 7.5 days, p = 0.189), retention in care at 12 months regardless of time to linkage (RR 1.48, 95% CI 1.18-1.86, p = 0.002), assessment for ART eligibility (RR 1.20, 95% CI 1.07-1.34, p = 0.004), ART initiation (RR 1.16, 95% CI 0.96-1.40, p = 0.12), mean time to ART initiation from time of HIV testing (7 days versus 14 days, p < 0.001), viral suppression among those on ART for ≥6 months (RR 0.97, 95% CI 0.88-1.07, p = 0.55), loss to follow-up at 12 months after HIV testing (RR 0.56, 95% CI 0.40-0.79, p = 0.002), and death (N = 78) within 12 months of HIV testing (RR 0.80, 95% CI 0.46-1.35, p = 0.41). Limitations of this study include a small number of clusters and the inability to evaluate the incremental effectiveness of individual components of the combination strategy. CONCLUSIONS: A combination strategy inclusive of 5 evidence-based interventions aimed at multiple steps in the HIV care continuum was associated with significant increase in linkage to care plus 12-month retention. This strategy offers promise of enhanced outcomes for HIV-positive patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT01904994.

Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

BACKGROUND: Attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression. METHODS AND FINDINGS: We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: Same-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov number NCT01900080.