by
E. Jennifer Edelman;
Stephen A. Maisto;
Nathan B. Hansen;
Christopher J. Cutter;
James Dziura;
Lynn E. Fiellin;
Patrick G. O'Connor;
Roger Bedimo;
Cynthia Gibert;
Vincent Marconi;
David Rimland;
Maria C. Rodriguez-Barradas;
Michael S. Simberkoff;
Amy C. Justice;
Kendall J. Bryant;
David A. Fiellin
Unhealthy alcohol use is common among HIV-positive patients, yet effective evidence-based treatments are rarely provided in clinical settings providing HIV care. Further, given patient variability in response to initial treatments, stepped care approaches may be beneficial. We describe the rationale, aims and study design for the current Starting Treatment for Ethanol in Primary care Trials (STEP Trials); three parallel randomized controlled effectiveness trials being conducted in five Infectious Disease Clinics. Participants meeting criteria for: 1) at-risk drinking, 2) moderate alcohol use with liver disease (MALD), or 3) alcohol use disorder (AUD) are randomized to integrated stepped care versus treatment as usual. For those with at-risk drinking or MALD, integrated stepped care starts with a one session brief intervention and follow-up 2-week telephone booster. Based on pre-specified nonresponse criteria, participants may be “stepped up” at week 4 to receive four sessions of motivational enhancement therapy (MET) and “stepped up” again at week 12 for addiction physician management (APM) and consideration of alcohol pharmacotherapy. For those with AUD, integrated stepped care begins with APM. Non-responders may be “stepped up” at week 4 to receive MET and again at week 12 for a higher level of care (e.g. intensive outpatient program). The primary outcome is alcohol consumption assessed at 24 weeks, and secondary outcome is the VACS Index, a validated measure of HIV morbidity and mortality risk. Results from the STEP Trials should inform future research and the implementation of interventions to address unhealthy alcohol use among HIV-positive individuals.
by
Matthew S. Freiberg;
Ionut Bebu;
Russell Tracy;
Kaku So-Armah;
Jason Okulicz;
Anuradha Ganesan;
Adam Armstrong;
Thomas O'Bryan;
David Rimland;
Amy C. Justice;
Brian K. Agan;
Infectious Disease Clinical Research Program HIV Working Group
The mechanism underlying the excess risk of non-AIDS diseases among HIV infected people is unclear. HIV associated inflammation/hypercoagulability likely plays a role. While antiretroviral therapy (ART) may return this process to pre-HIV levels, this has not been directly demonstrated. We analyzed data/specimens on 249 HIV+ participants from the US Military HIV Natural History Study, a prospective, multicenter observational cohort of >5600 active duty military personnel and beneficiaries living with HIV. We used stored blood specimens to measure D-dimerand Interleukin-6 (IL-6) at three time points: pre-HIV seroconversion, ≥6 months post-HIV seroconversion but prior to ART initiation, and ≥6 months post-ART with documented HIV viral suppression on two successive evaluations. We evaluated the changes in biomarker levels between time points, and the association between these biomarker changes and future non-AIDS events. During a median follow-up of 3.7 years, there were 28 incident non-AIDS diseases. At ART initiation, the median CD4 count was 361 cells/mm3; median duration of documented HIV infection 392 days; median time on ART was 354 days. Adjusted mean percent increase in D-dimer levels from pre-seroconversion to post-ART was 75.1% (95% confidence interval 24.6-148.0, p = 0.002). This increase in D-dimer was associated with a significant 22% increase risk of future non-AIDS events (p = 0.03). Changes in IL-6 levels across time points were small and not associated with future non-AIDS events. In conclusion, ART initiation and HIV viral suppression does not eliminate HIV associated elevation in D-dimer levels. This residual pathology is associated with an increased risk of future non-AIDS diseases.
by
Julie A. Womack;
Terrence E. Murphy;
Harini Bathulapalli;
Kathleen M. Akgun;
Cynthia Gibert;
Ken M. Kunisaki;
David Rimland;
Maria Rodriguez-Barradas;
H. Klar Yaggi;
Amy C. Justice;
Nancy S. Redeker
by
P. Todd Korthuis;
David A. Fiellin;
Kathleen A. McGinnis;
Melissa Skanderson;
Amy C. Justice;
Adam J. Gordon;
Donna Almario Doebler;
Steven M. Asch;
Lynn E. Fiellin;
Kendall Bryant;
Cynthia L. Gibert;
Stephen Crystal;
Matthew Bidwell Goetz;
David Rimland;
Maria C. Rodriguez-Barradas;
Kevin L. Kraemer
HIV-infected patients with substance use experience suboptimal health outcomes, possibly because of variations in care. OBJECTIVES: To assess the association between substance use and the quality of HIV care (QOC) received. RESEARCH DESIGN: Retrospective cohort study. SUBJECTS: HIV-infected patients enrolled in the Veterans Aging Cohort Study. MEASURES: We collected self-report substance use data and abstracted 9 HIV quality indicators (QIs) from medical records. Independent variables were unhealthy alcohol use (AUDIT-C score ≥4) and illicit drug use (self-report of stimulants, opioids, or injection drug use in past year). Main outcome was the percentage of QIs received, if eligible. We estimated associations between substance use and QOC using multivariable linear regression. RESULTS: The majority of the 3410 patients were male (97.4%) and black (67.0%) with a mean age of 49.1 years (SD = 8.8). Overall, 25.8% reported unhealthy alcohol use, 22% illicit drug use, and participants received 81.5% (SD = 18.9) of QIs. The mean percentage of QIs received was lower for those with unhealthy alcohol use versus not (59.3% vs. 70.0%, P < 0.001) and those using illicit drugs vs. not (57.8% vs. 70.7%, P < 0.001). In multivariable models, unhealthy alcohol use (adjusted β-2.74; 95% confidence interval:-4.23 to-1.25) and illicit drug use (adjusted β-3.51; 95% CI:-4.99 to-2.02) remained inversely associated with the percentage of QIs received. CONCLUSIONS: Although the overall QOC for these HIV-infected Veteran patients was high, gaps persist for those with unhealthy alcohol and illicit drug use. Interventions that address substance use in HIV-infected patients may improve the QOC received.
by
Kirsha S. Gordon;
E. Jennifer Edelman;
Amy C. Justice;
David A. Fiellin;
KAthleen Akgun;
Stephen Crystal;
Mona Duggal;
Joseph L. Goulet;
David Rimland;
Kendall J. Bryant
Black and Hispanic (minority) MSM have a higher incidence of HIV than white MSM. Multiple sexual partners, being under the influence of drugs and/or alcohol during sex, having a detectable HIV-1 RNA, and non-condom use are factors associated with HIV transmission. Using data from the Veterans Aging Cohort Study, we consider minority status and sexual orientation jointly to characterize and compare these factors. White non-MSM had the lowest prevalence of these factors (p < 0.001) and were used as the comparator group in calculating odds ratios (OR). Both MSM groups were more likely to report multiple sex partners (white MSM OR 7.50; 95 % CI 5.26, 10.71; minority MSM OR 10.24; 95 % CI 7.44, 14.08), and more likely to be under the influence during sex (white MSM OR 2.15; 95 % CI 1.49, 3.11; minority MSM OR 2.94; 95 % CI 2.16, 4.01). Only minority MSM were more likely to have detectable HIV-1 RNA (OR 1.87; 95 % CI 1.12, 3.11). Both MSM groups were more likely to use condoms than white non-MSM. These analyses suggest that tailored interventions to prevent HIV transmission among minority MSM are needed, with awareness of the potential co-occurrence of risk factors.
by
Christopher T. Rentsch;
Janet P. Tate;
Tessa Steel;
Adeel A. Butt;
Cynthia L. Gibert;
Laurence Huang;
Margaret Pisani;
Guy W. Soo Hoo;
Stephen Crystal;
Maria C. Rodriguez-Barradas;
Sheldon T. Brown;
Matthew S. Freiberg;
Christopher J. Graber;
Joon W. Kim;
David Rimland;
Amy C. Justice;
David A. Fiellin;
Kristina A. Crothers;
Kathleen M. Akgun
Background:HIV, hepatitis C virus (HCV), and alcohol-related diagnoses (ARD) independently contribute increased risk of all-cause hospitalization. We sought to determine annual medical intensive care unit (MICU) admission rates and relative risk of MICU admission between 1997 and 2014 among people with and without HIV, HCV, and ARD, using data from the largest HIV and HCV care provider in the United States.
Setting:Veterans Health Administration.
Methods:Annual MICU admission rates were calculated among 155,550 patients in the Veterans Aging Cohort Study by HIV, HCV, and ARD status. Adjusted rate ratios and 95% confidence intervals (CIs) were estimated with Poisson regression. Significance of trends in age-adjusted admission rates were tested with generalized linear regression. Models were stratified by calendar period to identify shifts in MICU admission risk over time.Results:Compared to HIV-/HCV-/ARD- patients, relative risk of MICU admission decreased among HIV-mono-infected patients from 61% (95% CI: 1.56 to 1.65) in 1997-2009% to 21% (95% CI: 1.16 to 1.27) in 2010-2014, increased among HCV-mono-infected patients from 22% (95% CI: 1.16 to 1.29) in 1997-2009% to 54% (95% CI: 1.43 to 1.67) in 2010-2014, and remained consistent among patients with ARD only at 46% (95% CI: 1.42 to 1.50). MICU admission rates decreased by 48% among HCV-uninfected patients (P-trend <0.0001) but did not change among HCV+ patients (P-trend = 0.34).
Conclusion:HCV infection and ARD remain key contributors to MICU admission risk. The impact of each of these conditions could be mitigated with combination of treatment of HIV, HCV, and interventions targeting unhealthy alcohol use.
by
Emily A. Wang;
Kathleen A. McGinnis;
Jessica B. Long;
Kathleen M. Akguen;
E. Jennifer Edelman;
David Rimland;
Karen H. Wang;
Amy C. Justice;
David A. Fiellin
Background and Objectives One in seven HIV-infected individuals is incarcerated each year. We used data from the Veterans Aging Cohort Study (VACS) to explore the relationship between incarceration and HIV disease outcomes and evaluate potential mediators of this relationship.
Methods HIV disease outcomes included: low CD4 counts (<200 cells/mL), detectable viral RNA loads (>500 copies/mL), and the VACS Index score. We performed a mediation analysis among 1,591 HIV-infected patients to examine whether unhealthy alcohol use, drug use, primary care engagement, or antiretroviral adherence mediated observed associations.
Results Among 1,591 HIV-infected patients, 47% reported having a history of incarceration. In multivariate analyses, a history of incarceration was associated with a higher VACS Index score (β 2.47, 95% CI 0.52-4.43). Mediation analysis revealed that recent drug use attenuated the association by 22% (β 1.93, 95% CI -0.06, 3.91) while other proposed mediators did not. Conclusions and Scientific Significance Improving access to drug treatment when incarcerated and upon release may be an important target to improving the health of HIV-infected individuals with a history of incarceration. (Am J Addict 2015;24:178-184)
by
T.B. Depp;
K.A. McGinnis;
K. Kraemer;
K.M. Akguen;
E.J. Edelman;
D.A. Fiellin;
A.A. Butt;
S. Crystal;
A.J. Gordon;
M. Freiberg;
C.L. Gibert;
David Rimland;
K.J. Bryant;
K. Crothers
Objective: To determine the association between HIV infection and other risk factors for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Design: Longitudinal, national Veterans Aging Cohort Study including 43 618 HIV-infected and 86 492 uninfected veterans. Methods: AECOPD was defined as an inpatient or outpatient COPD ICD-9 diagnosis accompanied by steroid and/or antibiotic prescription within 5 days. We calculated incidence rate ratios (IRR) and 95% confidence intervals (CI) for first AECOPD over 2 years and used Poisson regression models to adjust for risk factors. Results: Over 234 099 person-years of follow-up, 1428 HIV-infected and 2104 uninfected patients had at least one AECOPD. HIV-infected patients had an increased rate of AECOPD compared with uninfected (18.8 vs. 13.3 per 1000 person-years, P < 0.001). In adjusted models, AECOPD risk was greater in HIV-infected individuals overall (IRR 1.54; 95% CI 1.44-1.65), particularly in those with more severe immune suppression when stratified by CD4 cell count (cells/ml) compared with uninfected (HIV-infected CD4+ < 200: IRR 2.30, 95% CI 2.10-2.53, HIV-infected CD4+ ≥ 200-349: IRR 1.32, 95% CI 1.15-1.51, HIV-infected CD4+≥350: IRR 0.99, 95% CI 0.88-1.10). HIV infection also modified the association between current smoking and alcohol-related diagnoses with risk for AECOPD such that interaction terms for HIV and current smoking or HIV and alcohol-related diagnoses were each significantly associated with AECOPD. Conclusion: HIV infection, especially with lower CD4+ cell count, is an independent risk factor for AECOPD. Enhanced susceptibility to harm from current smoking or unhealthy alcohol use in HIV-infected patients may also contribute to the greater rate of AECOPD.
by
E. Jennifer Edelman;
Stephen A. Maisto;
Nathan B. Hansen;
Christopher J. Cutter;
James Dziura;
Yanhong Deng;
Lynn E. Fiellin;
Patrick G. O'Connor;
Roger Bedimo;
Cynthia L. Gibert;
Vincent Marconi;
David Rimland;
Maria C. Rodriguez-Barradas;
Michael S. Simberkoff;
Janet P. Tate;
Amy C. Justice;
Kendall J. Bryant;
David A. Fiellin
Background: At-risk levels of alcohol use threaten the health of patients with HIV (PWH), yet evidence-based strategies to decrease alcohol use and improve HIV-related outcomes in this population are lacking. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among PWH and at-risk alcohol use. Methods: In this multi-site, randomized trial conducted between January 28, 2013 through July 14, 2017, we enrolled PWH and at-risk alcohol use [defined as alcohol consumption of ≥ 14 drinks per week or ≥ 4 drinks per occasion in men ≤ 65 years old or ≥ 7 drinks per week or ≥ 3 drinks per occasion in women or men > 65 years old]. ISAT (n = 46) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 47) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat principles. Results: Despite a multi-pronged approach, we only recruited 37% of the target population (n = 93/254). Among ISAT participants, 50% advanced to Step 2, among whom 57% advanced to Step 3. Participants randomized to ISAT and TAU had no observed difference in drinks per week over the past 30 days at week 24 (primary outcome) [least square means (Ls mean) (95% CI) = 8.8 vs. 10.6; adjusted mean difference (AMD) (95% CI) = - 0.4 (- 3.9, 3.0)]. Conclusion: An insufficient number of patients were interested in participating in the trial. Efforts to enhance motivation of PWH with at-risk alcohol use to engage in alcohol-related research and build upon ISAT are needed. Trial registration Clinicaltrials.gov: NCT01410123, First posted August 4, 2011
by
E. Jennifer Edelman;
Stephen A. Maisto;
Nathan B. Hansen;
Christopher J. Cutter;
James Dziura;
Yanhong Deng;
Lynn E. Fiellin;
Patrick G. CYConnor;
Roger Bedimo;
Cynthia L. Gibert;
Vincent Marconi;
David Rimland;
Maria C. Rodriguez-Barradas;
Michael S. Simberkoff;
Janet P. Tate;
Amy C. Justice;
Kendall J. Bryant;
David A. Fiellin
Background: There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease. Methods: In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat. Results: Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [−3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = −0.2 [−0.9, 0.5]), ALT (AMD [95% CI] = −7 [−20, 7]) and AST (AMD [95% CI] = −4 [−15, 7]) at week 24 compared to TAU. Conclusion: ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.