Clinical Presentations and Treatment Outcomes of Mycoplasma genitalium Infections at a Large New York City Health Care System.

BACKGROUND: Mycoplasma genitalium (MG) is an emerging sexually transmitted infection. Treatment of MG is complicated by increasing resistance to primary treatment regimens, including macrolides and fluoroquinolones. Understanding the various clinical presentations and relative effectiveness of treatments for MG is crucial to optimizing care. METHODS: Patients with a positive MG nucleic acid amplification test between July 1, 2019, and June 30, 2021, at a large health system in New York City were included in a retrospective cohort. Demographics, clinical presentations, coinfections, treatment, and follow-up microbiologic tests were obtained from the electronic medical record. Associations with microbiologic cure were evaluated in bivariate and multivariable logistic regression models. RESULTS: Five hundred two unique patients had a positive MG nucleic acid amplification test result during the study period. Male individuals presented predominantly with urethritis (117 of 187 [63%]) and female individuals with vaginal symptoms (142 of 315 [45%]). Among patients with follow-up testing who received a single antibiotic at the time of treatment, 43% (90 of 210) had persistent infection and 57% (120 of 210) had microbiologic cure. Eighty-two percent of patients treated with moxifloxacin had microbiologic cure compared with 41% of patients receiving azithromycin regimens ( P < 0.001). In multivariable analysis, treatment with moxifloxacin was associated with 4 times the odds of microbiologic cure relative to low-dose azithromycin (adjusted odds ratio [aOR], 4.18; 95% confidence interval, 1.73-10.13; P < 0.01). CONCLUSIONS: Clinical presentations of MG vary, with urethritis or vaginal symptoms in most cases. Among patients who received a single antibiotic, only treatment with moxifloxacin was significantly associated with microbiologic cure relative to low-dose azithromycin.

HealthCall: Smartphone Enhancement of Brief Interventions to Improve HIV Medication Adherence Among Patients in HIV Care.

Heavy drinking among people living with HIV (PLWH) reduces ART adherence and worsens health outcomes. Lengthy interventions are not feasible in most HIV care settings, and patients infrequently follow referrals to outside treatment. Utilizing visual and video features of smartphone technology, we developed HealthCall as an electronic means of increasing patient involvement in a brief intervention to reduce drinking and improve ART adherence. The objective of the current study is to evaluate the efficacy of HealthCall to improve ART adherence among PLWH who drink heavily when paired with two brief interventions: the National Institute on Alcoholism and Alcohol Abuse (NIAAA) Clinician's Guide (CG) or Motivational Interviewing (MI). Therefore, we conducted a 1:1:1 randomized trial among 114 participants with alcohol dependence at a large urban HIV clinic. Participants were randomized to one of three groups: (1) CG only (n = 37), (2) CG and HealthCall (n = 38), or (3) MI and HealthCall (n = 39). Baseline interventions targeting drinking reduction and ART adherence were ~ 25 min, with brief (10-15 min) booster sessions at 30 and 60 days. The outcome was ART adherence assessed using unannounced phone pill-count method (possible adherence scores: 0-100%) at 30-day, 60-day, 3, 6, and 12 months. Analyses were conducted using generalized linear mixed models with pre-planned contrasts. Of the 114 enrolled patients, 58% were male, 75% identified as Black/African American, 28% were Hispanic, and 62% had less than a high school education. The mean age was 47.5 years (standard deviation [SD] 10 years) and the mean number of years since they were diagnosed with HIV was 18.6 (SD 7.6). Participants assigned to HealthCall to extend the CG had increased levels of ART adherence at 60-day and 6-month follow-up (compared to CG only), although there was no statistically significant difference by 12-month follow-up. Participants who were assigned to HealthCall to extend the MI never had statistically significant higher levels of ART adherence. These results suggest that the use of a smartphone app can be used to initially extend the reach of a brief drinking intervention to improve ART adherence over a short period of time; however, sustained long-term improvements in ART adherence after intervention activity ends remains a challenge.

Anorectal Testing for Mpox Virus Infection in Men Who Have Sex With Men With and Without Proctitis.

We performed anorectal testing in 18 cis-gender men who have sex with men with symptoms consistent with mpox virus (MPXV) infection. We found rectal MPXV DNA in 9/9 with and 7/9 without proctitis. Future study of anorectal testing is needed and may inform the diagnosis and pathogenesis of MPXV disease.

Remdesivir for the Treatment of Covid-19 - Final Report.

BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. RESULTS: A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%). CONCLUSIONS: Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).

Maintaining mask momentum in transplant recipients.

The widespread use of facemasks has been a crucial element in the control of the SARS-CoV-2 pandemic.  With mounting evidence for mask efficacy against respiratory infectious diseases and greater acceptability of this intervention, it is proposed that masking should continue after the pandemic has abated to protect some of our most vulnerable patients, recipients of stem cell and solid organ transplants. This may involve not only masking these high-risk patients, but possibly their close contacts and the healthcare workers involved in their care. We review the evidence for mask efficacy in prevention of respiratory viruses other than SARS-CoV-2 and address the burden of disease in transplant recipients.  Although we acknowledge that there are limited data on masking to prevent infection in transplant recipients, we propose a framework for the study and implementation of routine masking as a part of infection prevention interventions after transplantation.

"It's Like Plan B but for HIV!" Design and Evaluation of a Media Campaign to Drive Demand for PEP.

Post-exposure Prophylaxis (PEP) is an effective yet underutilized HIV prevention tool. PEPTALK developed and evaluated a media campaign to drive demand for PEP among men who have sex with men (MSM) and transgender women (TW) living in high HIV prevalence areas in New York City. Formative qualitative research (38 in-depth interviews and five focus groups [N = 48]) with Black or African-American MSM or TW who reported condomless sex with a HIV-positive/unknown status man was conducted to inform campaign design. We assessed the impact of the campaign, 15 bus shelter ads and low or no-cost social media, by assessing change in the proportions of new PEP patient visits, to the clinical site where the campaign directed consumers, using one-sided z-test for proportions, before and after the media campaign. The proportion of new PEP patients increased significantly after the media campaign in the periods examined, suggesting that such campaigns may increase PEP demand.

An expanded HIV screening strategy in the Emergency Department fails to identify most patients with undiagnosed infection: insights from a blinded serosurvey.

Screening for HIV in Emergency Departments (EDs) is recommended to address the problem of undiagnosed HIV. Serosurveys are an important method for estimating the prevalence of undiagnosed HIV and can provide insight into the effectiveness of an HIV screening strategy. We performed a blinded serosurvey in an ED offering non-targeted HIV screening to determine the proportion of patients with undiagnosed HIV who were diagnosed during their visit. The study was conducted in a high-volume, urban ED and included patients who had blood drawn for clinical purposes and had sufficient remnant specimen to undergo deidentified HIV testing. Among 4752 patients not previously diagnosed with HIV, 1403 (29.5%) were offered HIV screening and 543 (38.7% of those offered) consented. Overall, undiagnosed HIV was present in 12 patients (0.25%): six among those offered screening (0.4%), and six among those not offered screening (0.2%). Among those with undiagnosed HIV, two (16.7%) consented to screening and were diagnosed during their visit. Despite efforts to increase HIV screening, more than 80% of patients with undiagnosed HIV were not tested during their ED visit. Although half of those with undiagnosed HIV were missed because they were not offered screening, the yield was further diminished because a substantial proportion of patients declined screening. To avoid missed opportunities for diagnosis in the ED, strategies to further improve implementation of HIV screening and optimize rates of consent are needed.

Expanding Hospital Human Immunodeficiency Virus Testing in the Bronx, New York and Washington, District of Columbia: Results From the HPTN 065 Study.

Background: Human immunodeficiency virus (HIV) testing is critical for both HIV treatment and prevention. Expanding testing in hospital settings can identify undiagnosed HIV infections. Methods: To evaluate the feasibility of universally offering HIV testing during emergency department (ED) visits and inpatient admissions, 9 hospitals in the Bronx, New York and 7 in Washington, District of Columbia (DC) undertook efforts to offer HIV testing routinely. Outcomes included the percentage of encounters with an HIV test, the change from year 1 to year 3, and the percentages of tests that were HIV-positive and new diagnoses. Results: From 1 February 2011 to 31 January 2014, HIV tests were conducted during 6.5% of 1621016 ED visits and 13.0% of 361745 inpatient admissions in Bronx hospitals and 13.8% of 729172 ED visits and 22.0% of 150655 inpatient admissions in DC. From year 1 to year 3, testing was stable in the Bronx (ED visits: 6.6% to 6.9%; inpatient admissions: 13.0% to 13.6%), but increased in DC (ED visits: 11.9% to 15.8%; inpatient admissions: 19.0% to 23.9%). In the Bronx, 0.4% (408) of ED HIV tests were positive and 0.3% (277) were new diagnoses; 1.8% (828) of inpatient tests were positive and 0.5% (244) were new diagnoses. In DC, 0.6% (618) of ED tests were positive and 0.4% (404) were new diagnoses; 4.9% (1349) of inpatient tests were positive and 0.7% (189) were new diagnoses. Conclusions: Hospitals consistently identified previously undiagnosed HIV infections, but universal offer of HIV testing proved elusive.

Undiagnosed HIV and HCV Infection in a New York City Emergency Department, 2015.

OBJECTIVES: To measure undiagnosed HIV and HCV in a New York City emergency department (ED). METHODS: We conducted a blinded cross-sectional serosurvey with remnant serum from specimens originally drawn for clinical indications in the ED. Serum was deduplicated and matched to (1) the hospital's electronic medical record and (2) the New York City HIV and HCV surveillance registries for evidence of previous diagnosis before being deidentified and tested for HIV and HCV. RESULTS: The overall prevalence of HIV was 5.0% (250/4990; 95% confidence interval [CI] = 4.4%, 5.7%); the prevalence of undiagnosed HIV was 0.2% (12/4990; 95% CI = 0.1%, 0.4%); and the proportion of undiagnosed HIV was 4.8% (12/250; 95% CI = 2.5%, 8.2%). The overall prevalence of HCV (HCV RNA ≥ 15 international units per milliliter) was 3.9% (196/4989; 95% CI = 2.8%, 5.1%); the prevalence of undiagnosed HCV was 0.8% (38/4989; 95% CI = 0.3%, 1.3%); and the proportion of undiagnosed HCV was 19.2% (38/196; 95% CI = 11.4%, 27.0%). CONCLUSIONS: Undiagnosed HCV was more prevalent than undiagnosed HIV in this population, suggesting that aggressive testing initiatives similar to those directed toward HIV should be mounted to improve HCV diagnosis.

Increased HIV testing among hospitalized patients who declined testing in the emergency department.

Health-care systems have serial encounters with many of the same patients across care settings; however, few studies have examined the role of reoffering HIV testing after a patient declines. We assessed whether an intervention to increase HIV testing among hospitalized patients was associated with increased testing among those who declined a test while in the Emergency Department (ED). We studied 8-week periods pre- and post-implementation of an electronic medical record (EMR)-based intervention to increase HIV testing among hospitalized patients. We included all patients 21-64 years old who had no prior HIV test, declined HIV testing in the ED, and were subsequently hospitalized. We used logistic regression to test for an association between time of hospital admission (pre- vs. post-intervention) and whether an HIV test was performed prior to discharge. Pre- and post-implementation, 220 and 218 patients who declined HIV testing in the ED were hospitalized, respectively. There were no significant demographic or clinical differences among patients pre- and post-implementation. Pre- and post-implementation, the median proportion of patients tested weekly was 6.7% (IQR 6.5%, 10.0%) and 41.4% (IQR 33.3%, 41.9%), respectively (aOR 6.2: 95%CI: 3.6, 10.6). HIV testing increased among hospitalized patients who declined a test in the ED after implementation of an EMR-based intervention. Almost half of the patients who declined testing in the ED ultimately underwent testing after it was reoffered during hospitalization, suggesting that the decision to undergo HIV testing is a dynamic process. Leveraging EMR resources may be an effective tool for expanding HIV testing, and testing should be reoffered to patients who previously declined.

Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the Infectious Diseases Society of America.

Evidence-based guidelines for the management of persons infected with human immunodeficiency virus (HIV) were prepared by an expert panel of the HIV Medicine Association of the Infectious Diseases Society of America. These updated guidelines replace those published in 2009. The guidelines are intended for use by healthcare providers who care for HIV-infected patients. Since 2009, new antiretroviral drugs and classes have become available, and the prognosis of persons with HIV infection continues to improve. However, with fewer complications and increased survival, HIV-infected persons are increasingly developing common health problems that also affect the general population. Some of these conditions may be related to HIV infection itself or its treatment. HIV-infected persons should be managed and monitored for all relevant age- and sex-specific health problems. New information based on publications from the period 2009-2013 has been incorporated into this document.

Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV Medicine Association of the Infectious Diseases Society of America.

Evidence-based guidelines for the management of persons infected with human immunodeficiency virus (HIV) were prepared by an expert panel of the HIV Medicine Association of the Infectious Diseases Society of America. These updated guidelines replace those published in 2009. The guidelines are intended for use by healthcare providers who care for HIV-infected patients. Since 2009, new antiretroviral drugs and classes have become available, and the prognosis of persons with HIV infection continues to improve. However, with fewer complications and increased survival, HIV-infected persons are increasingly developing common health problems that also affect the general population. Some of these conditions may be related to HIV infection itself or its treatment. HIV-infected persons should be managed and monitored for all relevant age- and sex-specific health problems. New information based on publications from the period 2009-2013 has been incorporated into this document.

Development of an electronic medical record-based algorithm to identify patients with unknown HIV status.

Individuals with unknown HIV status are at risk for undiagnosed HIV, but practical and reliable methods for identifying these individuals have not been described. We developed an algorithm to identify patients with unknown HIV status using data from the electronic medical record (EMR) of a large health care system. We developed EMR-based criteria to classify patients as having known status (HIV-positive or HIV-negative) or unknown status and applied these criteria to all patients seen in the affiliated health care system from 2008 to 2012. Performance characteristics of the algorithm for identifying patients with unknown HIV status were calculated by comparing a random sample of the algorithm's results to a reference standard medical record review. The algorithm classifies all patients as having either known or unknown HIV status. Its sensitivity and specificity for identifying patients with unknown status are 99.4% (95% CI: 96.5-100%) and 95.2% (95% CI: 83.8-99.4%), respectively, with positive and negative predictive values of 98.7% (95% CI: 95.5-99.8%) and 97.6% (95% CI: 87.1-99.1%), respectively. Using commonly available data from an EMR, our algorithm has high sensitivity and specificity for identifying patients with unknown HIV status. This algorithm may inform expanded HIV testing strategies aiming to test the untested.

Implementation of an Mpox Vaccination Program at a Large Sexual Health Clinic in the Bronx-Lessons in Vaccine Equity.

Mpox caused a global outbreak in 2022. Among 249 people who received mpox vaccination at a sexual health clinic in the Bronx, New York, those with private vs public insurance were more likely to complete the series. No mpox cases were seen during follow-up at a median 121 days (IQR, 97-139).

Economic Cost of the HealthCall Smartphone Intervention to Reduce Heavy Alcohol Drinking in Adults With HIV.

OBJECTIVE: Alcohol use among people living with HIV (PLWH) can reduce adherence and worsen health outcomes. We evaluated the economic cost of an effective smartphone application (HealthCall) to reduce drinking and improve antiretroviral adherence among heavy-drinking PLWH participating in a randomized trial. METHOD: Participants were randomized to receive a brief drinking-reduction intervention, either (a) the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Clinician's Guide (CG-only, n = 37), (b) CG enhanced by HealthCall to monitor daily alcohol consumption (CG+HealthCall, n = 38), or (c) motivational interviewing delivered by a nonclinician enhanced by HealthCall (MI+HealthCall, n = 39). We used micro-costing techniques to evaluate start-up costs and incremental costs per participant incurred from the health care sector perspective in 2018 U.S. dollars. We also investigated potential cost offsets using participant-reported health care utilization. RESULTS: Participants attended three intervention visits, and each visit cost on average $29 for CG-only, $32 for CG+HealthCall, and $15 for MI+HealthCall. The total intervention cost per participant was $94 for CG-only, $114 for CG+HealthCall, and $57 for MI+HealthCall; the incremental cost of CG+HealthCall compared with CG-only was $20 per participant, and the incremental savings of MI+HealthCall compared with CG-only was $37 per participant. No significant differences in health care utilization occurred among the three groups over 12 months. CONCLUSIONS: The cost of enhancing CG with the HealthCall application for heavy-drinking PLWH was modestly higher than using the CG alone, whereas MI enhanced with HealthCall delivered by a nonclinician had a lower cost than CG alone. HealthCall may be a low-cost enhancement to brief interventions addressing alcohol use and antiretroviral adherence among PLWH.

Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case.

Background: Clinical trials initiated during emerging infectious disease outbreaks must quickly enroll participants to identify treatments to reduce morbidity and mortality. This may be at odds with enrolling a representative study population, especially when the population affected is undefined. Methods: We evaluated the utility of the Centers for Disease Control and Prevention's COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), the COVID-19 Case Surveillance System (CCSS), and 2020 United States (US) Census data to determine demographic representation in the 4 stages of the Adaptive COVID-19 Treatment Trial (ACTT). We compared the cumulative proportion of participants by sex, race, ethnicity, and age enrolled at US ACTT sites, with respective 95% confidence intervals, to the reference data in forest plots. Results: US ACTT sites enrolled 3509 adults hospitalized with COVID-19. When compared with COVID-NET, ACTT enrolled a similar or higher proportion of Hispanic/Latino and White participants depending on the stage, and a similar proportion of African American participants in all stages. In contrast, ACTT enrolled a higher proportion of these groups when compared with US Census and CCSS. The proportion of participants aged ≥65 years was either similar or lower than COVID-NET and higher than CCSS and the US Census. The proportion of females enrolled in ACTT was lower than the proportion of females in the reference datasets. Conclusions: Although surveillance data of hospitalized cases may not be available early in an outbreak, they are a better comparator than US Census data and surveillance of all cases, which may not reflect the population affected and at higher risk of severe disease.

Sequential antiretroviral adherence measurement using electronic bottle cap monitors in a cohort of HIV-infected adults.

Most studies employing electronic bottle monitors to measure antiretroviral adherence are limited to 24 weeks of duration, providing a snapshot of adherence from a treatment course that may be lifelong. The stability of these measures in individual patients over time has not been previously described. We measured antiretroviral adherence using Medication Event Monitoring System (MEMS) caps in a patient cohort in 2004 and 2005 and repeated the measurement in 2008 and 2009. Forty-eight participants completed both monitoring periods. Mean adherence rates in the first and second periods were 74.2% and 68.9%, respectively. Adherence rates from the 2 periods for individual participants were highly correlated (Spearman rho = .66, P < .001).

Navigating Human Immunodeficiency Virus Screening Recommendations for People on Pre-Exposure Prophylaxis and the Need to Update Testing Algorithms.

Incident HIV infections occurring in people on PrEP may have delayed seroconversion. New CDC guidelines recommend the addition of HIV-1 viral load for screening for all on PrEP. We believe antigen/antibody screening should continue for tenofovir-based PrEP at this time.

HealthCall: A randomized trial assessing a smartphone enhancement of brief interventions to reduce heavy drinking in HIV care.

INTRODUCTION: Heavy drinking among people living with HIV (PLWH) worsens their health outcomes and disrupts their HIV care. Although brief interventions to reduce heavy drinking in primary care are effective, more extensive intervention may be needed in PLWH with moderate-to-severe alcohol use disorder. Lengthy interventions are not feasible in most HIV primary care settings, and patients seldom follow referrals to outside treatment. Utilizing visual and video features of smartphone technology, we developed the "HealthCall" app to provide continued engagement after brief intervention, reduce drinking, and improve other aspects of HIV care with minimal demands on providers. We conducted a randomized trial of its efficacy. METHODS: The study recruited alcohol-dependent PLWH (n = 114) from a large urban HIV clinic. Using a 1:1:1 randomized design, the study assigned patients to: Motivational Interviewing (MI) plus HealthCall (n = 39); NIAAA Clinician's Guide (CG) plus HealthCall (n = 38); or CG-only (n = 37). Baseline MI and CG interventions took ~25 min, with brief (10-15 min) 30- and 60-day booster sessions. HealthCall involved daily use of the smartphone app (3-5 min/day) to report drinking and health in the prior 24 h. Outcomes assessed at 30 and 60 days and at 3, 6 and 12 months included drinks per drinking day (DpDD; primary outcome) and number of drinking days, analyzed with generalized linear mixed models and pre-planned contrasts. RESULTS: Study retention was excellent (85%-94% across timepoints). At 30 days, DpDD among patients in MI + HealthCall, CG + HealthCall, and CG-only was 3.80, 5.28, and 5.67, respectively; patients in MI + HealthCall drank less than CG-only and CG + HealthCall (IRRs = 0.62, 95% CI = 0.46, 0.84, and 0.64, 95% CI = 0.48, 0.87, respectively). At 6 months (end-of-treatment), DpDD was lower in CG + HealthCall (DpDD = 4.88) than MI + HealthCall (DpDD = 5.88) or CG-only (DpDD = 6.91), although these differences were not significant. At 12 months, DpDD was 5.73, 5.31, and 6.79 in MI + HealthCall, CG + HealthCall, and CG-only, respectively; DpDD was significantly lower in CG + HealthCall than CG-only (IRR = 0.71, 95% CI = 0.51, 0.98). CONCLUSIONS: During treatment, patients in MI + HealthCall had lower DpDD than patients in other conditions; however, at 12 months, drinking was lowest among patients in CG + HealthCall. Given the importance of drinking reduction and the low costs/time required for HealthCall, pairing HealthCall with brief interventions merits widespread consideration.

Therapeutic drug monitoring of protease inhibitors and efavirenz in HIV-infected individuals with active substance-related disorders.

BACKGROUND: Achieving targeted antiretroviral (ARV) plasma concentrations during long-term treatment in human immunodeficiency virus (HIV)-infected patients with substance-related disorders (SRDs) may be challenging due to a number of factors, including medication adherence, coinfection with hepatitis B or C virus, medication intolerance, and drug interactions. One approach to investigate these factors is to conduct therapeutic drug monitoring to measure ARV exposure during treatment. The objective of this study was to utilize therapeutic drug monitoring to compare efavirenz (EFV) and protease inhibitor pharmacokinetics in patients with and without SRDs. METHODS: This was a multicenter, cross-sectional open-label study in patients with HIV-1 infection receiving antiretroviral therapy (ART), with active (n=129) or without (n=146) SRD according to National Institute on Drug Abuse criteria. Two hundred seventy-five subjects who were receiving either protease inhibitor-based or EFV-based ART regimens for >6 months were enrolled at 4 HIV treatment centers with an equal distribution of SRD and non-SRD at each site. The patients were instructed during enrollment visits with regard to the importance of adherence before and after study visits. Demographics and routine clinical laboratory tests were recorded. RESULTS: Among the 275 patients, 47% had SRD with at least 1 substance. There were no significant differences between SRD and non-SRD groups for race, gender, age, or CD4 count at entry. A significantly higher proportion of patients with SRD had an entry HIV RNA plasma concentration>75 copies per milliliter compared with patients without SRD (40% vs 28%, P=0.044). Logistic regression modeling revealed an association between HIV RNA plasma concentration and African American race (P=0.017). A significantly higher proportion of SRDs also had an EFV or protease inhibitor trough concentration below the desired range (23% vs 9%, P=0.048). Significantly lower trough concentrations were noted in patients with SRDs receiving atazanavir (0.290 vs 0.976 µg/mL) or lopinavir (3.75 vs 5.30 µg/mL). CONCLUSIONS: The pharmacokinetic data indicate differences between HIV-infected patients with and without SRDs that may influence viral load suppression during long-term ART. These findings require additional investigation in a randomized design with more intensive pharmacokinetic assessment to identify individual factors that are contributing to suboptimal ARV exposure in patients with SRDs.