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.

Potential Utility of C-reactive Protein for Tuberculosis Risk Stratification among Patients with Non-Meningitic Symptoms at HIV Diagnosis in Low- and Middle-Income Countries.

Article Summary: We assessed the association between C-reactive protein (CRP) and Mycobacterium tuberculosis (TB) diagnosis in symptomatic patients at HIV diagnosis. We found that CRP concentrations can improve tuberculosis risk stratification, facilitating decision making about whether (specific) tuberculosis testing is indicated before antiretroviral therapy initiation. Background: The World Health Organization recommends initiating same-day ART while tuberculosis testing is underway for patients with non-meningitic symptoms at HIV diagnosis, though safety data are limited. C-reactive protein (CRP) testing may improve tuberculosis risk stratification in this population. Methods: In this baseline analysis of 498 adults (>18 years) with tuberculosis symptoms at HIV diagnosis who were enrolled in a trial of rapid ART initiation in Haiti, we describe test characteristics of varying CRP thresholds in the diagnosis of TB. We also assessed predictors of high CRP (≥3 mg/dL) using generalized linear models. Results: Eighty-seven (17.5%) patients were diagnosed with baseline TB. The median CRP was 33.0 mg/L (IQR: 5.1, 85.5) in those with TB, and 2.6 mg/L (IQR: 0.8, 11.7) in those without TB. As the CRP threshold increased from ≥1 mg/L to ≥10 mg/L, the positive predictive value for TB increased from 22.4% to 35.4%, and negative predictive value decreased from 96.9% to 92.3%. With CRP thresholds varying from <1 to <10 mg/L, a range from 25.5% to 64.9% of the cohort would have been eligible for same-day ART, and 0.8% to 5.0% would have untreated TB at ART initiation. Conclusions: CRP concentrations can be used to improve TB risk stratification, facilitating same-day decisions about ART initiation. Depending on the CRP threshold, one-quarter to two-thirds of patients could be eligible for same-day ART, with a reduction of 3-fold to 20-fold in the proportion with untreated TB, compared with a strategy of same-day ART while awaiting TB test results.

Superior Outcomes With Continuing Tenofovir Versus Switching to Zidovudine in Second-Line Antiretroviral Therapy in Haiti.

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.

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.

Prevalence of hypertension and cardiovascular risk factors among long-term AIDS survivors: A report from the field.

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.

Hypertension prevalence and risk factors among residents of four slum communities: population-representative findings from Port-au-Prince, Haiti.

OBJECTIVES: The aim of this study was to estimate the prevalence of hypertension and its risk factors among adults in four slum communities in Port-au-Prince. METHODS: Cluster area random sampling was used to select adults for a health and demographic survey, including anthropometric measurements. Hypertension was defined as SBP at least 140 mmHg and/or DBP at least 90 mmHg, or current hypertension treatment, and was age-standardized to WHO world population. Correlates of hypertension were tested using sex-stratified logistic regression. RESULTS: Overall, 20.3% of adults had hypertension (28.5% age-standardized), including 22.3% of men and 18.9% of women. Three percent of participants reported current hypertension treatment, and 49.5% of them had their hypertension controlled. Overweight/obesity (BMI ≥25) was the most common risk factor (20.6% among men, 48.5% among women), while smoking was less common (11.8 and 3.9%, respectively). Increasing age and hypertension prevalence in immediate surroundings were associated with greater odds of hypertension. Among men, having in-migrated in the 3 years prior (versus ≥3 years) was also associated with hypertension [adjusted odds ratio (aOR)=3.32, 95% confidence interval (95% CI): 1.79-6.17], as was overweight and obesity (aOR = 1.90, 95% CI: 1.09-3.33, and aOR = 5.73, 95% CI: 2.49-13.19, respectively) and nonreceipt of needed medical care in the preceding 6 months (aOR = 2.82, 95% CI: 1.35-5.88) among women. CONCLUSION: Hypertension prevalence was high across the age spectrum, in addition to substantial levels of overweight/obesity and unmet healthcare needs. It is important to better understand the possible effects of intraurban migration and environmental risk factors on hypertension and ensure that the benefits of increasingly cost-effective prevention and treatment programmes extend to slum residents.

A Successful Model of Expedited Antiretroviral Therapy for Clinically Stable Patients Living With HIV in Haiti.

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.

Retention in Care among Patients with Early HIV Disease in Haiti.

In September 2015, the World Health Organization updated their guidelines to recommend antiretroviral therapy (ART) for all people living with HIV. Countries are now in the process of implementing strategies to provide universal HIV treatment. We analyzed the rate of retention and time to ART eligibility (according to 2013 WHO guidelines) among 3,345 adult patients receiving positive HIV test results between February 1, 2003 and March 31, 2013 at the GHESKIO Clinic in Haiti, with WHO stage 1 or 2 disease and initial CD4 cell count >500 cells/mm3. Among the 3,345 patients, 2,423 (72%) were female, the median age was 33 years, 3,089 (92%) lived in Port-au-Prince, and 1,944 (58%) had attended no school or primary school only. The median initial CD4 cell count was 668 cells/mm3 (IQR: 572-834); over the subsequent 2 years, 1,485 patients (44%) were lost to follow-up and 7 (<1%) died pre-ART, 1,041 (31%) were retained in pre-ART care, and 819 (24%) initiated ART. In multivariate analysis, secondary education (aOR 1.27; 95% CI: 1.10-1.47), female gender (aOR: 1.28; 95% CI: 1.09-1.50), co-habitation (aOR: 1.31; 95% CI: 1.09-1.57), and residence in Port-au-Prince (aOR: 1.43; 95% CI: 1.09-1.88) were associated with retention in care. The median time from baseline CD4 count to ART eligibility was 1.7 years. Prior to the implementation of universal treatment, pre-ART attrition was high among patients who did not qualify for ART at presentation. Though implementing WHO recommendations for universal ART will require service expansion, it will likely result in improved retention for those at risk of being lost to follow-up.