Acceptability of Long-Acting Cabotegravir + Rilpivirine in a Large, Urban, Ambulatory HIV Clinic.

BACKGROUND: Outside of randomized controlled trials (RCTs), there are limited data regarding the acceptability of injectable long-acting cabotegravir + rilpivirine (LA-CAB+RPV) among persons living with HIV (PLWH). To evaluate acceptability, we describe participant-reported outcomes (PRO) of LA-CAB+RPV among a population underrepresented in RCTs. SETTING: Ruth M. Rothstein Core Center (CORE), large urban HIV clinic in Chicago, Illinois, USA. METHODS: We interviewed PLWH prescribed LA-CAB+RPV who receive primary care at CORE. PRO endpoints included treatment satisfaction, tolerability of injections, reasons for switching to LA-CAB+RPV, and unexpected effects of LA-CAB+RPV. Mean and standard deviations (mean±SD) and proportions (%) are reported. RESULTS: Among respondents (N=150), 67% identified as Non-Hispanic Black, 24% Hispanic, 56% male; the average age was 43 years (SD:13.2), and 37% were ≥50 years old. Most respondents (93%) completed ≥3 injection appointments at the time of interview. The most common reasons for switching to LA-CAB+RPV were no longer wanting to take pills (89%) and trouble taking their pills daily (58%). Treatment satisfaction was high (6.7±0.5 out of 7). Two-thirds (61%) reported an unexpected aspect of their life improved. Pain from injections was common (98%), with a mean pain score of 4.3 out of 10. Among those reporting pain, half (47%) reported pain decreased after initial injection. Among participants reporting pain score >6 (n=36), most (78%) reported no improvement since initial injection. CONCLUSIONS: We found high treatment satisfaction with LA-CAB+RPV in a diverse population. Participants reported moderate injection pain, which improved with time. Results suggest injectable LA-CAB+RPV will be met with acceptability across diverse participant populations.

Factors associated with non-adherence to antiretroviral therapy among female sex workers living with HIV in Hyderabad, India.

We determined factors associated with non-adherence (consuming <90% of monthly antiretroviral therapy) among female sex workers (FSWs). An interviewer-administered questionnaire was used in a sample of 100 South Indian FSWs living with HIV. We examined demographics, food insecurity, side effects, stigma, alcohol/substance use and self-efficacy. Non-adherence was assessed by self-report, pill-count and combined measures. Prevalence ratios and 95% confidence intervals (CIs) were calculated at p-value <0.1. Thirty-seven percent (33/90) of FSWs were non-adherent by pill-count, 29% (28/95) by self-report and 52% (51/99) by the combined measure. Seventy-six percent (76/100) of FSWs reported experience of at least one form of food insecurity in the past six months. In the regression analysis, arrest in the past year was independently associated with the combined measure of non-adherence (crude prevalence ratios 1.7, 95% CI 1.0-2.8). A successful combination adherence intervention should consider several of the socio-behavioral factors identified in this study including arrest and food insecurity.

Experience with antiretroviral electronic adherence monitoring among young African American men who have sex with men living with HIV: findings to inform a triaged real-time alert intervention.

We performed a pilot study among young African-American men who have sex with men (AAMSM) of real-time electronic adherence monitoring (EAM) in Chicago to explore acceptability and feasibility of EAM and to inform intervention development. We recruited 40 young AAMSM living with HIV on ART to participate in up to 3 months of monitoring with the Wisepill device. Participants were interviewed at baseline, in response to the first true adjudicated 1-dose, 3-day, and 7-day misses, and at the end of monitoring. Reasons for missing doses and the acceptability and feasibility of electronic monitoring were assessed using mixed methods. The median participant observation time was 90 days (N = 40). For 21 participants with 90 days of follow-up, <90% and <80% adherence occurred in 82% and 79%, respectively in at least one of their monitored months (n = 63 monitored months). The participants generally found the proposed intervention acceptable and useful. Although seven participants said the device attracted attention, none said it led to disclosure of their HIV status. This study found real-time EAM to be generally acceptable and feasible among YAAMSM living with HIV in Chicago. Future work will develop a triaged real-time EAM intervention including text alerts following detection of nonadherence.

Adherence to Antiretroviral Therapy Among HIV Patients in India: A Systematic Review and Meta-analysis.

We conducted a systematic review and meta-analysis to estimate the prevalence of adherence to antiretroviral therapy (ART) in India, the third largest HIV epidemic in the world. We identified peer reviewed literature published between 2007 and 2017 to extract data on ART adherence. We estimated pooled prevalence of adherence to ART using a random-effects model. Thirty-two eligible studies (n = 11,543) were included in the meta-analysis. Studies were mostly clustered in the southern and western Indian states. Overall, 77% (95% Confidence Interval 73-82; I2 = 96.80%) of patients had optimum adherence to ART. Women had higher prevalence of optimum adherence compared to men. Depression or anxiety were significant risk factors in seven of the fifteen studies reporting determinants of nonadherence. Studies should be performed to explore the reasons for gender gap in ART adherence and HIV program in India should prioritize mental health issues among HIV patients to improve ART adherence.

Antiretroviral therapy adherence among treatment-naive HIV-infected patients.

OBJECTIVE: To determine the incidence of antiretroviral therapy (ART) adherence among treatment-naive HIV-infected patients and to evaluate the impact of single-tablet regimen (STR) on ART adherence among this population. DESIGN: Retrospective cohort study. METHODS: We used a nationally representative sample of IQVIA LRx Lifelink individual level pharmacy claims database during 2011-2016, and defined adult patients with index date (first complete ART regimen prescription fill date) after 30 June 2011 as treatment naïve. We estimated ART adherence, measured as the proportion of days covered during 1 year following the index date. We conducted multivariable analysis to identify the factors associated with optimum adherence (≥90% proportion of days covered). We also compared adherence between patients prescribed STR and multiple-tablet regimens among those prescribed integrase strand transfer inhibitor-based or nonnucleoside reverse transcriptase inhibitor-based regimens. RESULTS: Overall 42.9% of the patients were optimally adherent. Adherence was significantly lower among blacks, Hispanics and patients in low-income communities. Adjusting for the covariates, patients on STR had higher incidence of optimum adherence compared with those on multiple-tablet regimens among patients on integrase strand transfer inhibitor-based regimens [49 vs. 24%, relative risk, 2.16 (95% confidence interval: 1.96-2.26)], but no significant difference was observed among those on nonnucleoside reverse transcriptase inhibitor-based regimen [45 vs. 45%, relative risk, 1.12 (95% confidence interval: 0.99-1.26)]. CONCLUSION: Low ART adherence observed among treatment-naive patients in this nationally representative study suggests the need for public health interventions to improve adherence among this population.

A triaged real-time alert intervention to improve antiretroviral therapy adherence among young African American men who have sex with men living with HIV: focus group findings.

BACKGROUND: Among persons living with HIV, poorer antiretroviral therapy adherence has been reported in African Americans and disproportionate mortality reported in young African American men who have sex with men (AAMSM) compared to whites. We report the results of focus groups with young AAMSM living with HIV that explore their opinions about the acceptability and feasibility of a triaged real-time missed dose alert intervention to improve treatment adherence. The purpose of this study is to develop a theory-driven triaged real-time adherence monitoring intervention to promote HIV medication adherence in young AAMSM. METHODS: We performed five focus groups and two individual interviews among young HIV-positive AAMSM (n = 25) in Chicago guided by the Technology Acceptance Model and explored perceptions regarding the monitoring concept including device issues and concerns about inclusion of support persons whose involvement is triggered by sustained missed doses. The purpose was to inform the development of this intervention in this population. RESULTS: Generally, the participants found the proposed intervention acceptable and useful. Privacy was a major concern for participants especially with attention to possible disclosure of their HIV status by receiving a medication-related text that someone else might view and could lead to unwanted attention. There was concern that the device could be confused with a taser. Approximately half of the men already had a close personal contact that helped them with medication taking. Some participants acknowledged that the notification might lead to friction. CONCLUSIONS: A triaged real-time alert intervention to improve treatment adherence is acceptable and feasible among young AAMSM living with HIV.

Acceptability, Feasibility, and Preliminary Efficacy of a Theory-Based Relational Embodied Conversational Agent Mobile Phone Intervention to Promote HIV Medication Adherence in Young HIV-Positive African American MSM.

An embodied conversational agent can serve as a relational agent and provide information, motivation, and behavioral skills. To evaluate the feasibility, acceptability, and preliminary efficacy of My Personal Health Guide, a theory-based mobile-delivered embodied conversational agent intervention to improve adherence to antiretroviral therapy in young African American men who have sex with men, we conducted this prospective pilot study using a 3-month pre-post design. Outcome measures included adherence, acceptability, feasibility, pre versus post health literacy, and pre versus post self-efficacy. There were 43 participants. Pill count adherence > 80% improved from 62% at baseline to 88% at follow-up (p = .05). The acceptability of the app was high. Feasibility issues identified included loss of usage data from unplanned participant app deletion. Health literacy improved whereas self-efficacy was high at baseline and follow-up. This pilot study of My Personal Health Guide demonstrated acceptability and preliminary efficacy in improving adherence in this important population.

Self-efficacy and ability to read as factors associated with antiretroviral therapy adherence in an HIV-infected population.

Determining the barriers and facilitators of antiretroviral adherence among former and current substance users may be useful in the creation of successful interventions that target this hard-to-reach population. We performed a cross-sectional study of HIV-infected patients (N = 123) prescribed antiretroviral therapy at four Chicago healthcare venues. Bivariate and multivariable analyses were performed to determine factors associated with non-adherence based on definitions of non-adherence (any missed doses) within the past 4-day, 14-day, and 1-month time periods. Factors consistently associated with non-adherence in bivariate and multivariate analyses, regardless of duration of non-adherence definition, were lower confidence in taking medication consistently and less self-reported ability to read. These data reveal the importance of self-efficacy and ability to read (rather than specific knowledge of CD4 and viral load definitions) in the design of interventions in a population of HIV-infected persons with significant substance use.

Late HIV Testing in a Cohort of HIV-Infected Patients in Puerto Rico.

OBJECTIVE: Late HIV testing (LT), defined as receiving an AIDS diagnosis within a year of one's first positive HIV test, is associated with higher HIV transmission, lower HAART effectiveness, and worse outcomes. Latinos represent 36% of LT in the US, yet research concerning LT among HIV cases in Puerto Rico is scarce. METHODS: Multivariable logistic regression analysis was used to identify factors associated with LT, and a Cochran‒Armitage test was used to determine LT trends in an HIV-infected cohort followed at a clinic in Puerto Rico specialized in the management and treatment of HIV. RESULTS: From 2000 to 2011, 47% of eligible patients were late testers, with lower median CD4 counts (54 vs. 420 cells/mm3) and higher median HIV viral load counts (253,680 vs. 23,700 copies/mL) than non-LT patients. LT prevalence decreased significantly, from 47% in 2000 to 37% in 2011. In a mutually adjusted logistic regression model, males, older age at enrollment and past history of IDU significantly increased LT odds, whereas having a history of amphetamine use decreased LT odds. When the data were stratified by mode of transmission, it became apparent that only the category men who have sex with men (MSM) saw a significant reduction in the proportion of LT, falling from 67% in 2000 to 33% in 2011. CONCLUSION: These results suggest a gap in early HIV detection in Puerto Rico, a gap that decreased only among MSM. An evaluation of the manner in which current HIV-testing guidelines are implemented on the island is needed.

A Case-control Study of Diphtheria in the High Incidence City of Hyderabad, India.

BACKGROUND: India accounts for approximately 72% of reported diphtheria cases globally, the majority of which occur in the state of Andhra Pradesh. The aim of this study is to better understand lack of knowledge on diphtheria vaccination and to determine factors associated with diphtheria and low knowledge and negative attitudes. METHODS: We performed a 1:1 case-control study of hospitalized diphtheria cases in Hyderabad. Eligible case patients were 10 years of age or older, resided within the city of Hyderabad and were diagnosed with diphtheria per the case definition. Patients admitted to the hospital for nonrespiratory communicable diseases and residing in the same geographic region as that of cases were eligible for enrolment as controls RESULTS: : There were no statistical differences in disease outcome by gender, education, economic status and mean room per person sleeping in the house in case and control subjects. Not having heard of diphtheria (adjusted odds ratio: 3.56; 95% confidence intervals: 1.58-8.04] and not believing that vaccines can prevent people from getting diseases (adjusted odds ratio: 3.99; 95% confidence intervals: 1.18-13.45) remained significantly associated with diphtheria on multivariate analysis. CONCLUSION: To reduce the burden of diphtheria in India, further efforts to educate the public about diphtheria should be considered.

A Step Towards Improving Food Safety in India: Determining Baseline Knowledge and Behaviors Among Restaurant Food Handlers in Chennai.

With the establishment of the Food Safety and Standards Authority of India (FSSAI) and new food safety regulations, a precedent has been set to prevent foodborne illness in India. The objective of the authors' study was to identify knowledge gaps among food handlers in Chennai, Tamil Nadu, to establish priorities for future intervention. A 44-question survey was administered to 156 food handlers at 36 restaurants in Chennai between April and June of 2011. The overall mean knowledge score was 49% and knowledge gaps related to hand hygiene, proper food cooking and holding temperatures, and cross contamination were identified. Food handlers with a Medical Fitness Certificate scored significantly higher than those without a certificate, after controlling for food safety training and level of education (p < .05). As the FSSAI standards now require a medical certificate for restaurant licensure and registration, consideration should be given to include an educational component to this certification with an explanation of expected food safety behavior.

Adherence to highly active antiretroviral therapy in Hyderabad, India: barriers, facilitators and identification of target groups.

We assessed the barriers and facilitators to highly active antiretroviral therapy adherence and determined their prevalence among HIV/AIDS patients in Hyderabad, India. We conducted a cross-sectional study among HIV-infected adults prescribed highly active antiretroviral therapy and receiving care from nine clinics. Depression was screened using Patient Health Questionnaire 9 and facilitators of HIV medication adherence were assessed using an 11-item scale which yielded a total positive attitude to disease score. Prevalence ratios of non-adherence between different categories of potential risk factors were calculated. We compared mean 'facilitators to adherence' scores between the adherent and non-adherent population. Multivariable Poisson regression with robust variance was used to identify independent risk factors. Among the 211 respondents, nearly 20% were non-adherent, approximately 8% had either moderately severe or severe depression and mean score for combined facilitators to medication adherence was 33.35 (±7.88) out of a possible 44 points. Factors significantly associated with non-adherence included older age, female sex worker, moderate-to-severe depression and the combined facilitators to medication adherence score. These data from a broad range of clinical settings in Hyderabad reveal that key groups to focus on for adherence intervention are female sex workers, older persons and those with depression.

Late HIV Testing in a Cohort of HIV-Infected Patients in Puerto Rico.

OBJECTIVE: Late HIV testing (LT), defined as receiving an AIDS diagnosis within a year of one's first positive HIV test, is associated with higher HIV transmission, lower HAART effectiveness, and worse outcomes. Latinos represent 36% of LT in the US, yet research concerning LT among HIV cases in Puerto Rico is scarce. METHODS: Multivariable logistic regression analysis was used to identify factors associated with LT, and a Cochran‒Armitage test was used to determine LT trends in an HIV-infected cohort followed at a clinic in Puerto Rico specialized in the management and treatment of HIV. RESULTS: From 2000 to 2011, 47% of eligible patients were late testers, with lower median CD4 counts (54 vs. 420 cells/mm3) and higher median HIV viral load counts (253,680 vs. 23,700 copies/mL) than non-LT patients. LT prevalence decreased significantly, from 47% in 2000 to 37% in 2011. In a mutually adjusted logistic regression model, males, older age at enrollment and past history of IDU significantly increased LT odds, whereas having a history of amphetamine use decreased LT odds. When the data were stratified by mode of transmission, it became apparent that only the category men who have sex with men (MSM) saw a significant reduction in the proportion of LT, falling from 67% in 2000 to 33% in 2011. CONCLUSION: These results suggest a gap in early HIV detection in Puerto Rico, a gap that decreased only among MSM. An evaluation of the manner in which current HIV-testing guidelines are implemented on the island is needed.

The descriptive epidemiology of yersiniosis: a multistate study, 2005-2011.

OBJECTIVES: Yersiniosis, a foodborne infection of zoonotic origin caused by the bacteria Yersinia enterocolitica and Yersinia pseudotuberculosis, is a reportable disease in 38 states. Both sporadic and foodborne outbreaks of yersiniosis have been reported in the U.S., with annual occurrence of an estimated 98,000 episodes of illness, 533 hospitalizations, and 29 deaths. We analyzed surveillance data from nine non-FoodNet-participating U.S. states during the period 2005-2011 to describe the epidemiology of this disease. METHODS: As part of a passive surveillance system, laboratory-confirmed cases of yersiniosis were reported to state health departments in Arizona, Illinois, Michigan, Missouri, Nebraska, North Carolina, South Carolina, Washington, and Wisconsin. We calculated overall, age-, and race-specific annual incidence rates per 100,000 population using 2010 Census data as the denominator. We used Poisson regression to examine seasonal variation and annual incidence trends by race, age group, and overall. RESULTS: The average annual incidence of yersiniosis was 0.16 cases per 100,000 population during 2005-2011. We observed a statistically significant decreasing annual trend of yersiniosis incidence among African Americans <5 years of age (p<0.01), whereas white people aged 19-64 years (p=0.08) and Hispanic people (p=0.05) had an overall increasing annual incidence of yersiniosis. We observed higher incidence during October-December (p<0.01) and January-March (p=0.03) quarters among African Americans, whereas white people had a higher incidence during April-June (p=0.05). CONCLUSION: This multistate analysis revealed differences in the epidemiology of yersiniosis by race/ethnicity that may be useful for future research and prevention efforts. While this study was consistent with the FoodNet report in recognizing the high and declining incidence among African American children and winter seasonality among African Americans, our study also identified April-June seasonality among the white population.

Efficacy of a food safety comic book on knowledge and self-reported behavior for persons living with AIDS.

INTRODUCTION: Persons living with AIDS are highly vulnerable to foodborne enteric infections with the potential for substantial morbidity and mortality. Educational materials about foodborne enteric infections intended for this immunocompromised population have not been assessed for their efficacy in improving knowledge or encouraging behavior change. METHODS/RESULTS: AIDS patients in four healthcare facilities in Chicago, New Orleans, and Puerto Rico were recruited using fliers and word of mouth to healthcare providers. Those who contacted research staff were interviewed to determine food safety knowledge gaps and risky behaviors. A food safety educational comic book that targeted knowledge gaps was created, piloted, and provided to these patients who were instructed to read it and return at least 2 weeks later for a follow-up interview. The overall food safety score was determined by the number of the 26 knowledge/belief/behavior questions from the survey answered correctly. Among 150 patients who participated in both the baseline and follow-up questionnaire, the intervention resulted in a substantial increase in the food safety score (baseline 59%, post-intervention 81%, p<0.001). The intervention produced a significant increase in all the food safety knowledge, belief, and behavior items that comprised the food safety score. Many of these increases were from baseline knowledge below 80 percent to well above 90%. Most (85%) of the patients stated they made a change to their behavior since receiving the educational booklet. CONCLUSION: This comic book format intervention to educate persons living with AIDS was highly effective. Future studies should examine to what extent long-term behavioral changes result.

Baseline knowledge survey of restaurant food handlers in suburban Chicago: do restaurant food handlers know what they need to know to keep consumers safe?

In the U.S., foodborne disease causes millions of illnesses annually, resulting in thousands of deaths. To reduce food poisoning, restaurant food handlers need accurate knowledge of food safety principles as a starting point for the outcome of optimal food safety behavior. The study described in this article determined food safety knowledge gaps among suburban Chicago restaurant food handlers. A cross-sectional survey of 729 food handlers at 211 suburban Chicago restaurants was conducted from June 2009 through February 2010. A 50-question survey was administered by a trained interviewer in either English or Spanish. Mixed-effects regression analysis identified risk factors associated with an overall food safety knowledge score. The mean overall knowledge score was only 72% and substantial knowledge gaps related to cross contamination, cooking, and holding and storage of food were identified. Spanish-speaking food handlers scored significantly lower than English-speaking food handlers (p < .05). Although certified food managers scored significantly higher than noncertified food handlers, their score was only 79%. These data provide targets for educational interventions to remedy knowledge gaps in food handlers in order to prevent food poisoning from restaurants.

Food Safety Knowledge, Beliefs and Behavior of Persons with AIDS: A Multicenter Study.

Persons living with AIDS are highly vulnerable to foodborne enteric infections including recurrent Salmonella septicemia and toxoplasmosis of the brain with the potential for substantial morbidity and mortality. Patients with immunologic AIDS in Chicago, New Orleans, and Bayamon were interviewed to determine gaps in food safety knowledge and prevalence of related behaviors in order to create targeted educational material for this population. A food safety score was calculated based on responses to 40 knowledge, belief, and behavior questions. Among 268 AIDS patients interviewed, the overall food safety score was 63% (range 28% to 93%). Many patients believed it was okay to eat higher risk food (38% for eating eggs served loose or runny, 27% for eating store-bought hot dogs without heating them first), 40% did not know that eating unpasteurized cheese may get germs inside their body that could cause hospitalization and possibly death, and 40% would not throw away salad that had been splashed with a few drops of raw chicken juice. These data demonstrate substantial knowledge gaps and behavioral risk related to acquisition of foodborne disease among AIDS patients. Healthcare providers should incorporate education regarding foodborne disease risk into routine outpatient discussion of improving and maintaining their health.

Enteric pathogens in stool samples of Chicago-area water recreators with new-onset gastrointestinal symptoms.

BACKGROUND: Characterizing pathogens responsible for recreational waterborne gastrointestinal illness is important in estimating risk and developing management strategies to prevent infection. Although water recreation is associated with sporadic cases of gastrointestinal illness, pathogens responsible for such illness are not well characterized. METHODS: A prospective cohort study was conducted enrolling non-water recreators (such as cyclists and joggers) and two groups of limited-contact waters recreators (such as boaters and kayakers): those on an effluent-dominated urban waterway and those on general use waters. Stool samples were collected from participants who developed gastrointestinal symptoms during a three-week follow-up period. Samples were analyzed for bacterial, viral, and protozoan pathogens. Logistic regression models were used to identify associations between water recreation and the presence of pathogens in stool samples. RESULTS: Among 10,998 participants without gastrointestinal symptoms at baseline, 2,429 (22.1%) developed at least one symptom during 21 days of follow-up. Of those, 740 (30.5%) provided at least one stool sample, of which 76 (10.3%) were positive for a pathogen. Rotavirus, found primarily among adults, accounted for 53 of the 76 (70%) infections. Among participants with symptoms, pathogen presence was not associated with water recreation or the extent of water exposure. The range of pathogens that could be identified and sample size limitations may have contributed to this lack of association. CONCLUSIONS: We did not find specific pathogens or groups of pathogens associated with recreational waterborne gastrointestinal illness. Although pathogens responsible for outbreaks of waterborne gastrointestinal illness have been described, microbes that cause sporadic cases remain poorly defined.

Temporal and spatial distribution of blastomycosis cases among humans and dogs in Illinois (2001-2007).

OBJECTIVE: To compare the temporal and spatial distribution of cases of blastomycosis among humans and dogs in Illinois. DESIGN: Retrospective cross-sectional survey. SAMPLE: Human and canine populations in Illinois from 2001 through 2007. PROCEDURES: For each year, human population data were obtained from the US Census Bureau, and the total number of dogs was estimated by use of a human population-based formula. Data regarding infections with Blastomyces dermatitidis in humans were accessed from the Illinois Department of Public Health. Data regarding B dermatitidis infections in dogs were acquired through a survey of a random sample of the 747 veterinary medical practices in Illinois. Statistical analyses of human and canine data were performed by use of t tests, ANOVA, odds ratio assessment, and regression modeling. RESULTS: Estimated annual incidence of human cases of blastomycosis in Illinois increased from 3.8 to 10.7 cases/1 million persons/y from 2001 through 2007. Analysis of data from 221 veterinary practices revealed that the mean estimated annual incidence of canine cases of blastomycosis was 8.3 times the mean estimated annual incidence of human cases, with a similar pattern of change and regional distributions. Thirty-eight counties reported either human or canine cases but not both. CONCLUSIONS AND CLINICAL RELEVANCE: The estimated annual incidence of blastomycosis in humans and dogs in Illinois increased during the period of interest. Veterinarians, physicians, and public health agencies should be encouraged to communicate with each other regarding diagnoses of blastomycosis in either species to facilitate early diagnosis and treatment.

Toxoplasmic encephalitis in an AIDS cohort at Puerto Rico before and after highly active antiretroviral therapy (HAART).

Highly active antiretroviral therapy (HAART) significantly reduced the toxoplasmic encephalitis (TE) incidence in acquired immunodeficiency syndrome (AIDS) patients. The TE incidence and mortality were evaluated in an AIDS cohort followed in Puerto Rico before, during, and after HAART implementation in the Island. Of the 2,431 AIDS studied patients 10.9% had TE diagnosis, with an incidence density that decreased from 5.9/100 person-years to 1.1/100 person-years after HAART. Cox proportional hazard analysis showed substantial mortality reduction among TE cases who received HAART. No mortality reduction was seen in those cases who received TE prophylaxis. Although this study shows a TE incidence and mortality reduction in the AIDS cohort after HAART, the incidence was higher than those reported in the United States AIDS patients. Poor TE prophylaxis compliance might explain the lack of impact of this intervention. Strengthening the diagnostic and opportune TE diagnosis and prompt initiation of HAART in susceptible patients is important to control this opportunistic infection.