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Introduction: Few studies have evaluated baseline predictors of clinical outcomes among people with HIV starting antiretroviral therapy (ART) in the modern era of rapid ART initiation. Methods: We conducted a secondary analysis of a randomized controlled trial of two rapid treatment initiation strategies for people with treatment-naïve HIV and tuberculosis symptoms at an urban clinic in Haiti. We used logistic regression models to assess associations between baseline characteristics and (1) retention in care at 48 weeks, (2) HIV viral load suppression at 48 weeks (among participants who underwent viral load testing), and (3) all-cause mortality. Results: 500 participants were enrolled in the study 11/2017-1/2020. Eighty-eight (18%) participants were diagnosed with tuberculosis, and ART was started in 494 (99%). After adjustment, less than secondary education (adjusted odds ratio [AOR] 0.21, 95% CI 0.10-0.46), dolutegravir initiation (AOR 2.57, 95% CI 1.22-5.43), age (AOR 1.42 per 10-year increase, 95% CI 1.01-1.99), and tuberculosis diagnosis (AOR 3.92, 95% CI 1.36-11.28) were significantly associated with retention. Age (AOR 1.36, 95% CI 1.05-1.75), dolutegravir initiation (AOR 1.75, 95% CI 1.07-2.85), and tuberculosis diagnosis (AOR 0.50, 95% CI 0.28-0.89) were associated with viral suppression. Higher CD4 cell count at enrollment (unadjusted odds ratio [OR] 0.69, 95% CI 0.55-0.87) and anemia (OR 4.86, 95% CI 1.71-13.81) were associated with mortality. Conclusions: We identified sociodemographic, treatment-related, clinical, and laboratory-based predictors of clinical outcomes. These characteristics may serve as markers of sub-populations that could benefit from additional interventions to support treatment success after rapid treatment initiation.

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Background: Eighty percent of global cardiovascular disease (CVD) is projected to occur in low- and middle -income countries (LMICs), yet local epidemiological data are scarce. We provide the first population-based, adjudicated CVD prevalence estimates in Port-au-Prince, Haiti to describe the spectrum of heart disease and investigate associated risk factors. Methods: Demographic, medical history, clinical, imaging and laboratory data were collected among adults recruited using multistage random sampling from 2019 to 2021. Prevalent CVD (heart failure, stroke, ischemic disease) were adjudicated using epidemiological criteria similar to international cohorts. Multivariable Poisson regressions assessed relationships between risk factors and prevalent CVD. Findings: Among 3003 participants, median age was 40 years, 58.1% were female, 70.2% reported income <1 USD/day, and all identified as Black Haitian. CVD age-adjusted prevalence was 14.7% (95% CI 13.3%, 16.5%), including heart failure (11.9% [95% CI 10.5%, 13.5%]), stroke (2.4% [95% CI 1.9%, 3.3%]), angina (2.1% [95% CI 1.6%, 2.9%]), myocardial infarction (1.0% [95% CI 0.6%, 1.8%]), and transient ischemic attack (0.4% [95% CI 0.2%, 1.0%]). Among participants with heart failure, median age was 57 years and 68.5% of cases were among women. The most common subtype was heart failure with preserved ejection fraction (80.4%). Heart failure was associated with hypertension, obesity, chronic kidney disease, depression, and stress. Interpretation: Early-onset heart failure prevalence is alarmingly high in urban Haiti and challenge modelling assumptions that ischemic heart disease and stroke dominate CVDs in LMICs. These data underscore the importance of local population-based epidemiologic data within LMICs to expedite the selection and implementation of evidence-based cardiovascular health policies targeting each country's spectrum of heart disease. Funding: This study was funded by NIH grants R01HL143788, D43TW011972, and K24HL163393, clinicaltrials.govNCT03892265.

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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.

Asunto(s)

Fármacos Anti-VIH , Infecciones por VIH , Tuberculosis , Adulto , Humanos , Fármacos Anti-VIH/uso terapéutico , Haití/epidemiología , Infecciones por VIH/complicaciones , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Tuberculosis/complicaciones , Tuberculosis/diagnóstico , Tuberculosis/tratamiento farmacológico , ARN

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Introduction: Obesity is associated with increased risk of non-communicable diseases and death and is increasing rapidly in low- and middle-income countries, including Haiti. There is limited population-based data on body mass index (BMI) and waist circumference (WC) and associated risk factors in Haiti. This study describes BMI and WC, and factors associated with obesity using a population-based cohort from Port-au-Prince. Methods: Baseline sociodemographic and clinical data were collected from participants in the Haiti CVD Cohort Study between March 2019 and August 2021. Weight was categorized by BMI (kg/m2) with obesity defined as ≥30 kg/m2. Abdominal obesity was defined using WC cutoffs of ≥80 cm for women and ≥94 cm for men based on WHO guidelines. Sociodemographic and behavioral risk factors, including age, sex, educational attainment, income, smoking status, physical activity, fat/oil use, daily fruit/vegetable consumption, and frequency of fried food intake were assessed for their association with obesity using a Poisson multivariable regression. Results: Among 2,966 participants, median age was 41 years (IQR: 28-55) and 57.6% were women. Median BMI was 24.0 kg/m2 (IQR: 20.9-28.1) and 508 (17.1%) participants were obese. Women represented 89.2% of the population with BMI ≥30 kg/m2. A total of 1,167 (68.3%) women had WC ≥80 cm and 144 (11.4%) men had WC ≥94 cm. BMI ≥30 kg/m2 was significantly more prevalent among women than men [PR 5.7; 95% CI: (4.3-7.6)], those 40-49 years compared to 18-29 years [PR 3.3; 95% CI: (2.4-4.6)], and those with income >10 USD per day compared to ≤1 USD [PR 1.3; 95% CI: (1.0-1.6)]. There were no significant associations with other health and behavioral risk factors. Discussion: In Haiti, women have an alarming 6-fold higher obesity prevalence compared to men (26.5 vs. 4.3%) and 89.2% of participants with obesity were women. Abdominal obesity was high, at 44.3%. Haiti faces a paradox of an ongoing national food insecurity crises and a burgeoning obesity epidemic. Individual, social, and environmental drivers of obesity, especially among women, need to be identified.

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Obesidad Abdominal , Obesidad , Masculino , Humanos , Femenino , Adulto , Obesidad Abdominal/complicaciones , Obesidad Abdominal/epidemiología , Prevalencia , Estudios de Cohortes , Haití/epidemiología , Obesidad/epidemiología

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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.

Asunto(s)

Fármacos Anti-VIH , Infecciones por VIH , Adolescente , Adulto , Fármacos Anti-VIH/uso terapéutico , Antirretrovirales/uso terapéutico , Niño , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Haití , Humanos , Sistemas de Atención de Punto , Carga Viral , Adulto Joven

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We compared viral suppression rates between patients who continued tenofovir disoproxil fumarate (TDF)/lamivudine (3TC) vs switched to zidovudine (ZDV)/3TC in combination with a boosted protease inhibitor after failure of first-line efavirenz/TDF/3TC. We found higher rates of viral suppression with continued TDF/3TC compared with switching to ZDV/3TC.

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INTRODUCTION: Long-term mortality among TB survivors appears to be higher than control populations without TB in many settings. However, data are limited among persons with HIV (PWH). We assessed the association between cured TB and long-term mortality among persons with PWH in Haiti. METHODS: A prospective cohort of PWH from the CIPRA HT-001 trial was followed from study enrolment (August 2005 to July 2008) to study closure (December 2018) to compare mortality between participants with and without TB. The index date for the survival analysis was defined as 240 days after TB diagnosis or randomization date. Time to death was described using Kaplan-Meier curves, and log-rank tests were used to compare time to death between the TB and no-TB cohorts. The association between TB and long-term mortality was estimated with multivariable Cox models. RESULTS: Of the 816 participants in the CIPRA HT-001 trial, 77 were excluded for a history of TB prior to study enrolment and 31 were excluded due to death or attrition prior to the index date, leaving 574 in the no-TB and 134 in the TB cohort. Twenty-four (17.9%) participants in the TB and 48 (8.4%) in the no-TB cohort died during follow-up. Five and 10-year mortality rates were 14.2% and 17.9% respectively, in the TB cohort, and 6.1% and 8.4% in the no-TB cohort. In Kaplan-Meier analysis, participants in the TB cohort had a significantly shorter time to death (log-rank p < 0.001). In multivariable analysis, TB treatment was the only predictor of mortality (HR: 2.78; 95% CI: 1.61, 4.79). Sensitivity analyses, which included only baseline TB cases, an index date of two years after TB diagnosis, and study enrolment and case-control matching yielded results that were consistent with primary analyses. CONCLUSIONS: PWH who are successfully treated for TB have higher long-term mortality than those who are never diagnosed with TB, even after accounting for acute TB-related mortality. A better understanding of the underlying mechanisms associated with TB sequelae is critically needed to guide specific interventions. Until then, more aggressive measures for health promotion and disease prevention are essential to improve long-term survival for PWH after TB treatment.

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Infecciones por VIH , Tuberculosis , Estudios de Cohortes , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , Haití , Humanos , Estudios Prospectivos , Tuberculosis/tratamiento farmacológico

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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.

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Enfermedades Cardiovasculares , Infecciones por VIH , Adulto , Enfermedades Cardiovasculares/epidemiología , Estudios de Cohortes , Haití/epidemiología , Humanos , Estudios Observacionales como Asunto , Factores de Riesgo

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INTRODUCTION: Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression. METHODS AND ANALYSIS: This non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10-24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence. ETHICS AND DISSEMINATION: This study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV. TRIAL REGISTRATION NUMBER: NCT03288246.

Asunto(s)

Infecciones por VIH , Sistemas de Atención de Punto , Adolescente , Adulto , Antirretrovirales/uso terapéutico , Niño , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Haití , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Carga Viral , Adulto Joven

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HIV infection is associated with increased risk and progression of cardiovascular disease (CVD), yet little is known about the prevalence of CVD risk factors among long-term AIDS survivors in resource-limited settings. Using routinely collected data, we conducted a retrospective study to describe the prevalence of CVD risk factors among a cohort of HIV-infected patients followed for over 10 years in Port-au Prince, Haiti. This cohort includes 910 adults who initiated antiretroviral therapy (ART) between 2003 and 2004 and remained in care between 2014 and 2016 when routine screening for CVD risk factors was implemented at a large clinic in Haiti. A total of 397 remained in care ≥10 years and received screening. At ART initiation, 59% were female, median age was 38 years (IQR 33-44), and median CD4 count was 117 cells/mm3 (IQR 34-201). Median follow-up time from ART initiation was 12.1 years (IQR 11.7-12.7). At screening, median CD4 count was 574 cells/mm3 (IQR 378-771), and 84% (282 of 336 screened) had HIV-1 RNA < 1000 copies/mL. Seventy-four percent of patients had at least 1 risk factor including 58% (224/385) with hypertension, 8% (24/297) diabetes, 43% (119/275) hypercholesterolemia, 8% (20/248) active smoking, and 10% (25/245) obesity. Factors associated with hypertension were age (adjusted OR 1.06, P < .001) and weight at screening (adjusted OR 1.02, P = .019). Long-term AIDS survivors have a high prevalence of CVD risk factors, primarily hypertension. Integration of cardiovascular screening and management into routine HIV care is needed to maximize health outcomes among aging HIV patients in resource-limited settings.

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Síndrome de Inmunodeficiencia Adquirida/complicaciones , Enfermedades Cardiovasculares/epidemiología , Infecciones por VIH/complicaciones , Hipertensión/epidemiología , Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Síndrome de Inmunodeficiencia Adquirida/inmunología , Síndrome de Inmunodeficiencia Adquirida/virología , Adulto , Antirretrovirales/uso terapéutico , Recuento de Linfocito CD4/métodos , Recuento de Linfocito CD4/estadística & datos numéricos , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/etiología , Diabetes Mellitus/epidemiología , Programas de Detección Diagnóstica/normas , Femenino , Infecciones por VIH/epidemiología , Infecciones por VIH/inmunología , Infecciones por VIH/virología , VIH-1/genética , Haití/epidemiología , Humanos , Hipercolesterolemia/epidemiología , Hipertensión/diagnóstico , Hipertensión/etiología , Masculino , Persona de Mediana Edad , Obesidad/epidemiología , Prevalencia , Estudios Retrospectivos , Factores de Riesgo , Fumar/epidemiología , Sobrevivientes/estadística & datos numéricos

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Centros Comunitarios de Salud , Infecciones por VIH/terapia , Modelos Organizacionales , Adolescente , Fármacos Anti-VIH/uso terapéutico , Recuento de Linfocito CD4 , Estudios de Cohortes , Servicios de Salud Comunitaria/organización & administración , Femenino , Haití , Humanos , Masculino , Retención en el Cuidado , Adulto Joven

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BACKGROUND: Recommendations for universal antiretroviral therapy have greatly increased the number of HIV-infected patients who qualify for treatment, particularly with early clinical disease. Less intensive models of care are needed for clinically stable patients. SETTING: A rapid pathway (RP) model of expedited outpatient care for clinically stable patients was implemented at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO) Center, Port-au-Prince, Haiti. Expedited visits included nurse-led assessments and point-of-service antiretroviral therapy dispensing. METHODS: We conducted a retrospective analysis including patients who initiated RP care between June 1, 2014, and September 30, 2015, comparing outcomes of patients with timely visit attendance (never >3 days late) with patients with ≥1 nontimely visit within 6 months before RP enrollment. We calculated retention in care and adherence at 12 months, and assessed predictors of both outcomes. RESULTS: Of the 2361 patients who initiated RP care during the study period, 1429 (61%) had timely visit attendance and 932 (39%) had ≥1 nontimely visit before RP enrollment. Among RP-enrolled patients, 94% were retained at 12 months and 75% had ≥90% adherence, with higher proportions in those with timely pre-RP visits (95% vs. 92%; 87% vs. 55%). In multivariable analysis, pre-RP visit timeliness was associated with both retention (adjusted odds ratio: 1.67; 95% confidence interval: 1.08 to 2.59) and adherence (adjusted odds ratio: 4.53; 95% confidence interval: 3.58 to 5.72). CONCLUSIONS: RP care was associated with high levels of retention and adherence for clinically stable patients. Timeliness of pre-RP visits was predictive of outcomes after RP initiation.

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Fármacos Anti-VIH/administración & dosificación , Infecciones por VIH/tratamiento farmacológico , Modelos Teóricos , Adulto , Fármacos Anti-VIH/uso terapéutico , Femenino , Haití , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Estudios Retrospectivos

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OBJECTIVE: The objective of this study was to determine how baseline blood pressure and incident hypertension related to antiretroviral therapy (ART) initiation, HIV-related inflammation and mortality in HIV-infected adults in a low-income country. METHODS: We conducted long-term follow-up of HIV-infected adults who had participated in a trial of early vs. delayed initiation of ART in Port-au-Prince, Haiti. Between 2005 and 2008, 816 HIV-infected adults were randomized to early (N = 408) vs. delayed ART (when CD4 cell count <200 cells/µl or AIDS-defining condition; N = 408). Blood pressure was measured every 3 months. Hypertension was diagnosed according to the Joint National Committee (JNC-7) guidelines. Biomarkers of inflammation and coagulation were measured from banked enrolment plasma samples. Survival analyses were performed using Stata 14. RESULTS: The median age at enrolment was 39 years. The median follow-up time was 7.3 years. The hypertension incidence rate was 3.41 per 100 person-years, and was similar in early and delayed ART groups. In multivariable models, independent predictors of incident hypertension were older age, higher BMI and plasma interleukin (IL)-6 levels (adjusted hazard ratio, aHR = 1.23, P < 0.001). Systolic pressure more than 140 mmHg at enrolment was associated with increased mortality (aHR = 2.47, P = 0.03) as was systolic pressure less than 90 mmHg (aHR = 2.25, P = 0.04). Prevalent and incident hypertension were also significantly associated with mortality. CONCLUSION: In a large prospective study of HIV-infected adults, we found a high incidence of hypertension associated with HIV-related inflammation. Baseline hypertension conferred a more than two-fold increased risk of death. Among HIV-infected adults in low-income countries, hypertension should be considered a serious threat to long-term survival.

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Presión Sanguínea , Países en Desarrollo , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/mortalidad , Hipertensión/epidemiología , Hipertensión/fisiopatología , Adulto , Factores de Edad , Fármacos Anti-VIH/uso terapéutico , Índice de Masa Corporal , Recuento de Linfocito CD4 , Femenino , Estudios de Seguimiento , Infecciones por VIH/complicaciones , Infecciones por VIH/inmunología , Haití/epidemiología , Humanos , Incidencia , Inflamación/sangre , Inflamación/virología , Interleucina-6/sangre , Masculino , Persona de Mediana Edad , Prevalencia , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Tiempo de Tratamiento

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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.

Asunto(s)

Fármacos Anti-VIH/uso terapéutico , Control de Enfermedades Transmisibles/métodos , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Adulto , Femenino , Haití , Humanos , Masculino , Persona de Mediana Edad , Factores de Tiempo

RESUMEN

In 2003, the Haitian Study Group on Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), a nonprofit organization, began administering antiretroviral therapy (ART) to its patients. This practice transformed HIV from a fatal disease to a more manageable chronic condition. However, relatively few studies focus on the experiences of survivors. This study provided a unique opportunity to interview patients who survived at least 10 years after being treated with ART at GHESKIO. The goal of the study was to elicit from patients their perspectives on what enabled them to survive with AIDS. Grounded Theory, a qualitative research method was used to guide data collection, coding, and analysis. Individual interviews were conducted, audio-taped, transcribed and analyzed in Creole, and translated into English. Data saturation was reached at 25 participants. Of which, 64% were women, the mean age was 49, range of 43-55 years, 24% were married, 44% had not completed elementary school, and 72% had no income, the remaining participants had incomes ranging from $1000 to $5000 annually. Qualitative analysis resulted in 681 codes, which were grouped into six categories: being spiritually grounded, having supportive interactions with providers, caring for children, setting personal goals, persevering and living life as usual, and maintaining strict medication adherence practices. The overarching theory was that having a reason to live despite one's circumstances and living life as usual enabled one to survive. Having a strong spiritual foundation coupled with supportive family and providers motivated participants to live and adhere to their ART. As the number of patients who are living longer with HIV in Haiti increases, results from this study will be important in helping tailor interventions that enhance their overall quality of life.

Asunto(s)

Antirretrovirales/uso terapéutico , Infecciones por VIH/psicología , Conocimientos, Actitudes y Práctica en Salud , Cumplimiento de la Medicación , Calidad de Vida , Sobrevivientes/psicología , Adolescente , Adulto , Antirretrovirales/administración & dosificación , Niño , Consejo , Femenino , Teoría Fundamentada , Infecciones por VIH/tratamiento farmacológico , Haití , Personal de Salud , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Motivación , Investigación Cualitativa , Apoyo Social , Espiritualidad

RESUMEN

BACKGROUND: High attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is widely reported. Though treatment guidelines have changed to broaden ART eligibility and services have been widely expanded over the past decade, data on the temporal trends in pre-ART outcomes are limited; such data would be useful to guide future policy decisions. METHODS: We evaluated temporal trends and predictors of retention for each step from HIV testing to ART initiation over the past decade at the GHESKIO clinic in Port-au-Prince Haiti. The 24,925 patients >17 years of age who received a positive HIV test at GHESKIO from March 1, 2003 to February 28, 2013 were included. Patients were followed until they remained in pre-ART care for one year or initiated ART. RESULTS: 24,925 patients (61% female, median age 35 years) were included, and 15,008 (60%) had blood drawn for CD4 count within 12 months of HIV testing; the trend increased over time from 36% in Year 1 to 78% in Year 10 (p<0.0001). Excluding transfers, the proportion of patients who were retained in pre-ART care or initiated ART within the first year after HIV testing was 84%, 82%, 64%, and 64%, for CD4 count strata ≤200, 201 to 350, 351 to 500, and >500 cells/mm3, respectively. The trend increased over time for each CD4 strata, and in Year 10, 94%, 95%, 79%, and 74% were retained in pre-ART care or initiated ART for each CD4 strata. Predictors of pre-ART attrition included male gender, low income, and low educational status. Older age and tuberculosis (TB) at HIV testing were associated with retention in care. CONCLUSIONS: The proportion of patients completing assessments for ART eligibility, remaining in pre-ART care, and initiating ART have increased over the last decade across all CD4 count strata, particularly among patients with CD4 count ≤350 cells/mm3. However, additional retention efforts are needed for patients with higher CD4 counts.

Asunto(s)

Fármacos Anti-VIH/administración & dosificación , Terapia Antirretroviral Altamente Activa/estadística & datos numéricos , Recuento de Linfocito CD4/métodos , Infecciones por VIH/tratamiento farmacológico , Adolescente , Adulto , Instituciones de Atención Ambulatoria , Fármacos Anti-VIH/uso terapéutico , Femenino , Haití , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven

RESUMEN

BACKGROUND: Attrition from HIV testing to antiretroviral therapy (ART) initiation is high. Strengthening linkages in care from testing to treatment may reduce attrition. This study addresses the question: can social workers accurately identify symptomatic patients during HIV testing and fast-track them for rapid provision of services? METHODS: This study took place at the Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections (GHESKIO) in Port-au-Prince, Haiti. We compared symptoms reported by social workers at HIV testing using a checklist to diagnoses made by physicians on an intake exam to determine if social workers could accurately identify symptomatic patients. RESULTS: Among the 437 HIV-positive patients included in the study, social workers reported stage-associated symptoms in 100% of patients diagnosed with WHO stage 3 or 4 conditions and in 87% of patients with WHO stage 1 or 2 conditions. The sensitivity, specificity, positive predictive value, and negative predictive value of social worker-reported symptoms for the diagnosis of a WHO stage 3 or 4 condition was 100%, 47%, 31%, and 100%, respectively. CONCLUSIONS: Social workers can identify symptomatic patients at HIV testing and refer them for fast-tracked services. This strategy may increase the rate of ART initiation among eligible patients.

Asunto(s)

Antirretrovirales/administración & dosificación , Infecciones por VIH/diagnóstico , Trabajadores Sociales , Triaje/organización & administración , Adulto , Antirretrovirales/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Haití/epidemiología , Humanos , Masculino , Tamizaje Masivo , Persona de Mediana Edad

RESUMEN

OBJECTIVE: We assessed the association between gender and mortality on antiretroviral therapy (ART) using identical models with and without sex-specific categories for weight and hemoglobin. DESIGN: Cohort study of adult patients on ART. SETTING: GHESKIO Clinic in Port-au-Prince, Haiti. PARTICIPANTS: 4,717 ART-naïve adult patients consecutively enrolled on ART at GHESKIO from 2003 to 2008. MAIN OUTCOME MEASURE: Mortality on ART; multivariable analyses were conducted with and without sex-specific categories for weight and hemoglobin. RESULTS: In Haiti, male gender was associated with mortality (OR 1.61; 95% CI: 1.30-2.00) in multivariable analyses with hemoglobin and weight included as control variables, but not when sex-specific interactions with hemoglobin and weight were used. CONCLUSIONS: If sex-specific categories are omitted, multivariable analyses indicate a higher risk of mortality for males vs. females of the same weight and hemoglobin. However, because males have higher normal values for weight and hemoglobin, the males in this comparison would generally have poorer health status than the females. This may explain why gender differences in mortality are sometimes observed after controlling for differences in baseline variables when gender-specific interactions with weight and hemoglobin are omitted.

Asunto(s)

Antirretrovirales/uso terapéutico , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Tamizaje Masivo/métodos , Adolescente , Adulto , Anciano , Análisis de Varianza , Recuento de Linfocito CD4 , Femenino , Infecciones por VIH/mortalidad , Haití/epidemiología , Humanos , Masculino , Tamizaje Masivo/organización & administración , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud/métodos , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Modelos de Riesgos Proporcionales , Factores de Riesgo , Factores Sexuales , Tasa de Supervivencia

RESUMEN

BACKGROUND: Adherence is key to the success of antiretroviral therapy. Enhanced partner support might benefit patients with previous treatment failure. We aimed to assess whether an enhanced partner-based support intervention with modified directly observed therapy would improve outcomes with second-line therapy in HIV-infected patients for whom first-line therapy had failed. METHODS: We did a multicentre, international, randomised clinical trial at nine sites in Botswana, Brazil, Haiti, Peru, South Africa, Uganda, Zambia, and Zimbabwe. Participants aged 18 years or older for whom first-line therapy had failed, with HIV RNA concentrations greater than 1000 copies per mL and with a willing partner, were randomly assigned (1:1), via computer-generated randomisation, to receive partner-based modified directly observed therapy or standard of care. Randomisation was stratified by screening HIV RNA concentration (≤10 000 copies per mL vs >10 000 copies per mL). Participants and site investigators were not masked to group assignment. Primary outcome was confirmed virological failure (viral load >400 copies per mL) by week 48. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00608569. FINDINGS: Between April 23, 2009, and Sept 29, 2011, we randomly assigned 259 participants to the modified directly observed therapy group (n=129) or the standard-of-care group (n=130). 34 (26%) participants in the modified directly observed therapy group achieved the primary endpoint of virological failure by week 48 compared with 23 (18%) participants in the standard-of-care group. The Kaplan-Meier estimated cumulative probability of virological failure by week 48 was 25·1% (95% CI 17·7-32·4) in the modified directly observed therapy group and 17·3% (10·8-23·7) in the standard-of-care group, for a weighted difference in standard of care versus modified directly observed therapy of -6·6% (95% CI -16·5% to 3·2%; p=0·19). 36 (14%) participants reported at least one grade 3 or higher adverse event or laboratory abnormality (n=21 in the modified directly observed therapy group and n=15 in the standard-of-care group). INTERPRETATION: Partner-based training with modified directly observed therapy had no effect on virological suppression. The intervention does not therefore seem to be a promising strategy to increase adherence. Intensive follow-up with clinic staff might be a viable approach in this setting. FUNDING: AIDS Clinical Trials Group and the National Institute of Allergy and Infectious Diseases, US National Institutes of Health.

Asunto(s)

Fármacos Anti-VIH/administración & dosificación , Terapia Antirretroviral Altamente Activa , Infecciones por VIH/tratamiento farmacológico , Cumplimiento de la Medicación/psicología , Adulto , Terapia Antirretroviral Altamente Activa/métodos , Citas y Horarios , Botswana , Brasil , Femenino , Infecciones por VIH/virología , Haití , Humanos , Masculino , Persona de Mediana Edad , Perú , Investigadores , Sudáfrica , Nivel de Atención , Insuficiencia del Tratamiento , Uganda , Estados Unidos , Carga Viral/efectos de los fármacos , Zimbabwe

RESUMEN

OBJECTIVE: Many studies include oral HIV-related endpoints that may be diagnosed by non-oral-health specialists (non-OHS) like nurses or physicians. Our objective was to assess the accuracy of clinical diagnoses of HIV-related oral lesions made by non-OHS compared to diagnoses made by OHS. METHODS: A5254, a cross-sectional study conducted by the Oral HIV/AIDS Research Alliance within the AIDS Clinical Trial Group, enrolled HIV-1-infected adults participants from six clinical trial units (CTU) in the US (San Francisco, New York, Chapel Hill, Cleveland, Atlanta) and Haiti. CTU examiners (non-OHS) received standardized training on how to perform an oral examination and make clinical diagnoses of specific oral disease endpoints. Diagnoses by calibrated non-OHS were compared to those made by calibrated OHS, and sensitivity and specificity computed. RESULTS: Among 324 participants, the majority were black (73%), men (66%), and the median CD4+ cell count 138 cells/mm(3). The overall frequency of oral mucosal disease diagnosed by OHS was 43% in US sites, and 90% in Haiti. Oral candidiasis (OC) was detected in 153 (47%) by OHS, with erythematous candidiasis (EC) the most common type (39%) followed by pseudomembranous candidiasis (PC; 26%). The highest prevalence of OC (79%) was among participants in Haiti, and among those with CD4+ cell count ≤ 200 cells/mm(3) and HIV-1 RNA > 1000 copies/mL (71%). The sensitivity and specificity of OC diagnoses by non-OHS were 90% and 92% (for EC: 81% and 94%; PC: 82% and 95%). Sensitivity and specificity were also high for KS (87% and 94%, respectively), but sensitivity was < 60% for HL and oral warts in all sites combined. The Candida culture confirmation of OC clinical diagnoses (as defined by ≥ 1 colony forming unit per mL of oral/throat rinse) was ≥ 93% for both PC and EC. CONCLUSION: Trained non-OHS showed high accuracy of clinical diagnoses of OC in comparison with OHS, suggesting their usefulness in studies in resource-poor settings, but detection of less common lesions may require OHS.

Asunto(s)

Competencia Clínica , Diagnóstico Bucal , Errores Diagnósticos , Infecciones por VIH/complicaciones , VIH-1 , Personal de Salud , Enfermedades de la Boca/diagnóstico , Adulto , Anciano , Recuento de Linfocito CD4 , Calibración , Estudios Transversales , Higienistas Dentales , Odontólogos , Diagnóstico Bucal/educación , Femenino , Haití/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Enfermedades de la Boca/complicaciones , Enfermedades de la Boca/epidemiología , Medicina Oral , Otolaringología , Prevalencia , Sensibilidad y Especificidad , Especialización , Estados Unidos/epidemiología , Carga Viral , Recursos Humanos , Adulto Joven