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1.  Preventing Loss of Independence through Exercise (PLIÉ): A Pilot Clinical Trial in Older Adults with Dementia 
PLoS ONE  2015;10(2):e0113367.
Background
Current dementia medications have small effect sizes, many adverse effects and do not change the disease course. Therefore, it is critically important to study alternative treatment strategies. The goal of this study was to pilot-test a novel, integrative group exercise program for individuals with mild-to-moderate dementia called Preventing Loss of Independence through Exercise (PLIÉ), which focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection.
Methods
We performed a 36-week cross-over pilot clinical trial to compare PLIÉ with usual care (UC) at an adult day program for individuals with dementia in San Francisco, CA. Assessments of physical performance, cognitive function, physical function, dementia-related behaviors, quality of life and caregiver burden were performed by blinded assessors at baseline, 18 weeks (cross-over) and 36 weeks. Our primary outcomes were effect sizes based on between-group comparisons of change from baseline to 18 weeks; secondary outcomes were within-group comparisons of change before and after cross-over.
Results
Twelve individuals enrolled (7 PLIÉ, 5 UC) and 2 withdrew (1 PLIÉ, 18 weeks; 1 UC, 36 weeks). Participants were 82% women (mean age, 84 ± 4 years); caregivers were 82% daughters (mean age, 56 ± 13 years). Effect sizes were not statistically significant but suggested potentially clinically meaningful (≥0.25 SDs) improvement with PLIÉ versus UC for physical performance (Cohen’s D: 0.34 SDs), cognitive function (0.76 SDs) and quality of life (0.83 SDs) as well as for caregiver measures of participant’s quality of life (0.33 SDs) and caregiver burden (0.49 SDs). Results were similar when within-group comparisons were made before and after cross-over.
Conclusions
PLIÉ is a novel, integrative exercise program that shows promise for improving physical function, cognitive function, quality of life and caregiver burden in individuals with mild-to-moderate dementia. Larger randomized, controlled trials are warranted.
Trial Registration
ClinicalTrials.gov NCT01371214
doi:10.1371/journal.pone.0113367
PMCID: PMC4324943  PMID: 25671576
2.  Site-nurse initiated Adherence and Symptom Support Telephone Calls for HIV-positive individuals starting antiretroviral therapy, ACTG 5031, a substudy of ACTG 384. 
HIV clinical trials  2013;14(5):235-253.
Background:
Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed.
Objective:
To compare a site-nurse initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy compare to the study site’s standard of care.
Methods:
A randomized controlled trial of site-nurse initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretrovirals. Subjects were randomized to receive site-nurse initiated telephone calls (intervention) or no additional calls above the site’s standard of care (control). Subjects received calls 1-3 days after initiating antiretrovirals, weeks 1, 2, 3, 6, 10, 14, 18, 22, 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits.
Results:
A total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with >95% mean Total Adherence, 87.9% and 91.2% (p=0.34) and mean self-reported Total Adherence, 97.9% and 98.4% in the intervention and control, respectively, or in symptom distress and clinical endpoints.
Conclusions:
In the context of a clinical trial, where self-reported adherence was exceptionally high, the site-nurse initiated telephone calls did not further improve self-reported adherence, symptom distress or clinical outcomes.
doi:10.1310/hct1405-235
PMCID: PMC4019013  PMID: 24144900
Adherence intervention; Nursing telephone support; Randomized Controlled Trial; Antiretroviral Therapy
3.  Family Adversity and Autonomic Reactivity Association With Immune Changes in HIV-Affected School Children 
Psychosomatic medicine  2013;75(6):10.1097/PSY.0b013e31829807fb.
Objective
To explore whether primary school entry is associated with changes in immune system parameters in HIV-affected children. HIV-affected children are vulnerable to psychosocial stressors, regardless of their own HIV serological status.
Methods
Data from 38 HIV+ and 29 HIV− children born to seropositive women were obtained before and after school entry. Measures included family adversity questionnaires, autonomic nervous system (ANS) reactivity (based on mean arterial responses to challenge tasks), and enumerative and functional changes in peripheral blood immune parameters.
Results
In comparison to children who were HIV−, children who were HIV+ at baseline had fewer CD4+ T lymphocytes (M = 916 vs. 1206 cells/mm3 × 103; F = 7.8, p = .007), more CD8+ cells (M = 1046 vs. 720 cells/mm3 ×103; F = 7.98, p = .006), and diminished NK cell cytotoxicity (M =−.29 vs. .41; F = 8.87, p = .004). School entry was associated with changes in immune parameters, but HIV status was not associated with the magnitude of changes. Changes in immune parameters following school entry were associated with family stress and pre school entry ANS reactivity. Highly ANS reactive children had either the greatest increase in CD8+ cells following school entry or the greatest decrease, depending upon reported levels of family adversity (B = 215.35; t = 3.74, p < .001). Changes in functional immune assays were significantly associated with the interactions between HIV status and ANS reactivity.
Conclusions
These results suggest that autonomic reactivity is associated with increased immunological sensitivity to adverse or challenging social contexts among children affected by HIV.
doi:10.1097/PSY.0b013e31829807fb
PMCID: PMC3830556  PMID: 23766380
HIV; children; stress; reactivity; immune
4.  The development of an RDoC-based treatment program for adolescent depression: “Training for Awareness, Resilience, and Action” (TARA) 
Major depressive disorder (MDD) is one of the current leading causes of disability worldwide. Adolescence is a vulnerable period for the onset of depression, with MDD affecting 8–20% of all youth. Traditional treatment methods have not been sufficiently effective to slow the increasing prevalence of adolescent depression. We therefore propose a new model for the treatment of adolescent depression – Training for Awareness, Resilience, and Action (TARA) – that is based on current understanding of developmental and depression neurobiology. The TARA model is aligned with the Research Domain Criteria (RDoC) of the National Institute of Mental Health. In this article, we first address the relevance of RDoC to adolescent depression. Second, we identify the major RDoC domains of function involved in adolescent depression and organize them in a way that gives priority to domains thought to be driving the psychopathology. Third, we select therapeutic training strategies for TARA based on current scientific evidence of efficacy for the prioritized domains of function in a manner that maximizes time, resources, and feasibility. The TARA model takes into consideration the developmental limitation in top-down cognitive control in adolescence and promotes bottom-up strategies such as vagal afference to decrease limbic hyperactivation and its secondary effects. The program has been informed by mindfulness-based therapy and yoga, as well as modern psychotherapeutic techniques. The treatment program is semi-manualized, progressive, and applied in a module-based approach designed for a group setting that is to be conducted one session per week for 12 weeks. We hope that this work may form the basis for a novel and more effective treatment strategy for adolescent depression, as well as broaden the discussion on how to address this challenge.
doi:10.3389/fnhum.2014.00630
PMCID: PMC4137278  PMID: 25191250
adolescent depression; RDoC; treatment development; emotion regulation; attention training; yoga-based movement; mindfulness
5.  Physician Perspectives on Comparative Effectiveness Research: Implications for Practice-based Evidence 
Comparative effectiveness research (CER) is defined by the Institute of Medicine as “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.” The goal of CER is to provide timely, useful evidence to healthcare decision makers including physicians, patients, policymakers, and payers. A prime focus for the use of CER evidence is the interaction between physician and patient. Physicians in primary practice are critical to the success of the CER enterprise. A 2009 survey suggests, however, that physician attitudes toward CER may be mixed—somewhat positive toward the potential for patient care improvement, yet negative toward potential restriction on physician freedom of practice. CER methods and goals closely parallel those of practice-based research, an important movement in family medicine in the United States since the 1970s. This article addresses apparent physician ambivalence toward CER and makes a case for family medicine engagement in CER to produce useful practice-based evidence. Such an effort has potential to expand care options through personalized medicine, individualized guidelines, focus on patient preferences and patient-reported outcomes, and study of complex therapeutic interventions, such as integrative care. Academic medical researchers will need to collaborate with experienced family physicians to identify significant practice-based research questions and design meaningful studies. Such collaborations would shape CER to produce high-quality practice-based evidence to inform family and community medicine.
doi:10.7453/gahmj.2012.1.4.004
PMCID: PMC3833509  PMID: 24278829
Comparative effectiveness research; practice-based evidence; complementary and alternative medicine; patient-reported outcomes
6.  Infectious Diseases Physicians' Attitudes and Practices Related to Complementary and Integrative Medicine: Results of a National Survey 
Background. Complementary and alternative medicine (CAM) and integrative medicine (IM) modalities are widely used by patients, including those with infectious diseases (ID). Methods. One thousand randomly selected ID practitioners were surveyed. The survey was divided into domains related to familiarity and recommendation, beliefs and attitudes, and use of CAM/IM modalities. Results. The response rate was 31%. ID physicians were most familiar with vitamin and mineral supplementation (83%), massage (80%), acupuncture (79%), chiropractic (77%), yoga (74%), and herbal medicine (72%). ID physicians most recommended vitamin and mineral supplementation (80%) and massage (62%). Yoga, meditation, and acupuncture were recommended by 52%, 45%, and 46%, respectively. Drug interactions, clinical research, and knowledge of CAM/IM modalities were factors that were considered a major influence. Almost 80% of respondents indicated an interest in IM versus 11% for CAM. Most respondents (75%) felt that IM modalities are useful, and more than 50% believed that they could directly affect the immune system or disease process. Conclusion. ID physicians expressed a markedly greater interest for IM versus CAM. They appear to be familiar and willing to recommend some CAM/IM modalities and see a role for these in the management of certain infectious diseases. Data regarding clinical efficacy and safety appear to be important factors.
doi:10.1155/2013/294381
PMCID: PMC3725713  PMID: 23935658
7.  Building a Strategic Framework for Comparative Effectiveness Research in Complementary and Integrative Medicine 
The increasing burden of chronic diseases presents not only challenges to the knowledge and expertise of the professional medical community, but also highlights the need to improve the quality and relevance of clinical research in this domain. Many patients now turn to complementary and integrative medicine (CIM) to treat their chronic illnesses; however, there is very little evidence to guide their decision-making in usual care. The following research recommendations were derived from a CIM Stakeholder Symposium on Comparative Effectiveness Research (CER): (1) CER studies should be made a priority in this field; (2) stakeholders should be engaged at every stage of the research; (3) CER study designs should highlight effectiveness over efficacy; (4) research questions should be well defined to enable the selection of an appropriate CER study design; (5) the CIM community should cultivate widely shared understandings, discourse, tools, and technologies to support the use and validity of CER methods; (6) Effectiveness Guidance Documents on methodological standards should be developed to shape future CER studies. CER is an emerging field and its development and impact must be reflected in future research strategies within CIM. This stakeholder symposium was a first step in providing systematic guidance for future CER in this field.
doi:10.1155/2012/531096
PMCID: PMC3544532  PMID: 23346206
8.  Psychiatric Risk Factors for HIV Disease Progression: The Role of Inconsistent Patterns of Anti-Retroviral Therapy Utilization 
Background
In the era of anti-retroviral therapy (ART), depression and substance use predict hastened HIV disease progression but the underlying biological or behavioral mechanisms that explain these effects are not fully understood.
Methods
Using outcome data from 603 participants enrolled in a randomized controlled trial of a behavioral intervention, binary logistic and linear regression were employed to examine whether inconsistent patterns of ART utilization partially mediated the effects of depression and substance use on higher HIV viral load over a 25-month follow-up.
Results
Elevated affective symptoms of depression independently predicted ART discontinuation (Adjusted OR [AOR] = 1.39, 95% CI = 1.08 – 1.78), and use of stimulants at least weekly independently predicted intermittent ART utilization (AOR = 2.62, 95% CI = 1.45 – 4.73). After controlling for the average self-reported percentage of ART doses taken and baseline T-helper (CD4+) count, elevated depressive symptoms predicted a 50% higher mean viral load, and weekly stimulant use predicted a 137% higher mean viral load. These effects became non-significant after accounting for inconsistent patterns of ART utilization, providing evidence of partial mediation.
Conclusions
Inconsistent patterns of ART utilization may partially explain the effects of depression and stimulant use on hastened HIV disease progression.
doi:10.1097/QAI.0b013e318201df63
PMCID: PMC3494991  PMID: 21116186
Access; Adherence; Antiretroviral; Cocaine; Depression; Disease Progression; Highly Active; HIV/AIDS; HIV Viral Load; Methamphetamine; Substance Use; Utilization
9.  A Randomized Noninferiority Trial of Standard Versus Enhanced Risk Reduction and Adherence Counseling for Individuals Receiving Post-Exposure Prophylaxis Following Sexual Exposures to HIV 
More intensive risk reduction and adherence counseling is necessary for higher-risk PEP users. Without integration into HIV testing and partner services settings, PEP may make an individual impact but is unlikely to make a public health impact.
Background. The National HIV/AIDS Strategy proposes to scale-up post-exposure prophylaxis (PEP). Intensive risk reduction and adherence counseling appear to be effective but are resource intensive. Identifying simpler interventions that maximize the HIV prevention potential of PEP is critical.
Methods. A randomized noninferiority study comparing 2 (standard) or 5 (enhanced) risk reduction counseling sessions was performed. Adherence counseling was provided in the enhanced arm. We measured changes in unprotected sexual intercourse acts at 12 months, compared with baseline; HIV acquisition; and PEP adherence. Outcomes were stratified by degree of baseline risk.
Results. We enrolled 457 individuals reporting unprotected intercourse within 72 h with an HIV-infected or at-risk partner. Participants were 96% male and 71% white. There were 1.8 and 2.3 fewer unprotected sex acts in the standard and enhanced groups. The maximum potential risk difference, reflected by the upper bound of the 95% confidence interval, was 3.9 acts. The difference in the riskier subset may have been as many as 19.6 acts. The incidence of HIV seroconversion was 2.9% and 2.6% among persons randomized to standard and enhanced counseling, respectively, with a maximum potential difference of 3.4%. The absolute and maximal HIV seroconversion incidence was 9.9% and 20.4% greater in the riskier group randomized to standard, compared with enhanced, counseling. Adherence outcomes were similar, with noninferiority in the lower risk group and concerning differences among the higher-risk group.
Conclusions. Risk assessment is critical at PEP initiation. Standard counseling is only noninferior for individuals with lower baseline risk; thus, enhanced counseling should be targeted to individuals at higher risk.
doi:10.1093/cid/cir333
PMCID: PMC3110285  PMID: 21653307
10.  Childhood Sexual Abuse Is Highly Associated With HIV Risk–Taking Behavior and Infection Among MSM in the EXPLORE Study 
Background
Previous studies have found high rates of childhood sexual abuse (CSA) among US men who have sex with men (MSM). CSA history has been associated with a variety of negative effects later in life including behaviors that place MSM at greater risk for HIV acquisition and transmission. The present analysis is the first to examine the longitudinal association between CSA and HIV infection, unprotected anal sex, and serodiscordant unprotected anal sex, as well as mediators of these relationships among a large sample of HIV-uninfected MSM.
Methods
The EXPLORE Study was a behavioral intervention trial conducted in 6 US cities over 48 months with HIV infection as the primary efficacy outcome. Behavioral assessments were done every 6 months via confidential computerized assessments. Longitudinal regression models were constructed, adjusting for randomization arm, geographical location of study site, age at enrollment, education, and race/ethnicity.
Results
Of the 4295 participants enrolled, 39.7% had a history of CSA. Participants with a history of CSA [adjusted hazards ratio = 1.30, 95% confidence interval (CI): 1.02 to 1.69] were at increased risk for HIV infection over study follow-up. A significant association was seen between history of CSA and unprotected anal sex (adjusted odds ratio = 1.24, 95% CI: 1.12 to 1.36) and serodiscordant unprotected anal sex (adjusted odds ratio = 1.30, 95% CI: 1.18 to 1.43). Among participants reporting CSA, the EXPLORE intervention had no effect in reducing HIV infection rates. Participants reporting CSA were significantly more likely to have symptoms of depression and use nonprescription drugs.
Conclusions
A predictive relationship between a history of CSA and subsequent HIV infection was observed among this large sample of HIV-uninfected MSM. Findings indicate that HIV-uninfected MSM with CSA histories are at greater risk for HIV infection, report higher rates of HIV sexual risk behavior, and may derive less benefit from prevention programs. Future HIV prevention interventions should address the specific mental health concerns of MSM with a history of CSA.
doi:10.1097/QAI.0b013e3181a24b38
PMCID: PMC3292283  PMID: 19367173
child sexual abuse; EXPLORE; HIV; MSM; sexual risk taking
11.  Use of a High Resolution Melting (HRM) Assay to Compare Gag, Pol, and Env Diversity in Adults with Different Stages of HIV Infection 
PLoS ONE  2011;6(11):e27211.
Background
Cross-sectional assessment of HIV incidence relies on laboratory methods to discriminate between recent and non-recent HIV infection. Because HIV diversifies over time in infected individuals, HIV diversity may serve as a biomarker for assessing HIV incidence. We used a high resolution melting (HRM) diversity assay to compare HIV diversity in adults with different stages of HIV infection. This assay provides a single numeric HRM score that reflects the level of genetic diversity of HIV in a sample from an infected individual.
Methods
HIV diversity was measured in 203 adults: 20 with acute HIV infection (RNA positive, antibody negative), 116 with recent HIV infection (tested a median of 189 days after a previous negative HIV test, range 14–540 days), and 67 with non-recent HIV infection (HIV infected >2 years). HRM scores were generated for two regions in gag, one region in pol, and three regions in env.
Results
Median HRM scores were higher in non-recent infection than in recent infection for all six regions tested. In multivariate models, higher HRM scores in three of the six regions were independently associated with non-recent HIV infection.
Conclusions
The HRM diversity assay provides a simple, scalable method for measuring HIV diversity. HRM scores, which reflect the genetic diversity in a viral population, may be useful biomarkers for evaluation of HIV incidence, particularly if multiple regions of the HIV genome are examined.
doi:10.1371/journal.pone.0027211
PMCID: PMC3206918  PMID: 22073290
12.  Recruitment of men who have sex with men for large HIV intervention trials: Analysis of the EXPLORE Study recruitment effort 
Testing HIV prevention strategies requires that researchers recruit participants at high risk of HIV infection. Data from the EXPLORE Study, a behavioral intervention trial involving men who have sex with men, were used to examine the relationship between recruitment strategies and participant characteristics, sexual risk behaviors and HIV incidence. The EXPLORE Study used a wide variety of recruitment strategies; no one strategy accounted for more than 20% of enrolled men. Younger men and men of color were more likely to be recruited through club and bar outreach, friend referral and street outreach. Men reporting ten or more sexual partners were more likely to be recruited through advertising and street outreach. Men reporting unprotected sex were more likely to be recruited through clinic referrals. HIV incidence did not significantly differ by recruitment strategy. Our findings support the need for a wide range of recruitment strategies in attracting MSM at high risk for HIV into clinical studies.
doi:10.1521/aeap.2010.22.1.28
PMCID: PMC3114877  PMID: 20166785
gay men; behavioral interventions; HIV; recruitment
13.  Relationships over Time between Mental Health Symptoms and Transmission Risk Among Persons Living with HIV 
Relationships between mental health symptoms (anxiety and depression) or a positive state of mind and behavior associated with HIV transmission (substance use and risky sexual behavior) were explored in a longitudinal study on persons living with HIV (PLH; n = 936) who were participants in a transmission-prevention trial. Bivariate longitudinal regressions were used to estimate the correlations between mental health symptoms and HIV-related transmission acts for three time frames: at the baseline interview; over 25 months; and from assessment to assessment. At baseline, mental health symptoms were associated with transmission acts. Elevated levels of mental health symptoms at baseline were associated with decreasing alcohol or marijuana use over 25 months. Over 25 months, an increasingly positive state of mind was associated with decreasing alcohol or marijuana use; an increasingly positive state of mind in the immediate condition and increasing depressive symptoms in the lagged condition were related to increasing risky sexual behavior. Our findings suggest that mental health symptoms precede a decrease in substance use and challenge self-medication theories. Changes in mental health symptoms and sexual behavior occur more in tandem.
doi:10.1037/a0018190
PMCID: PMC2845324  PMID: 20307117
HIV; Mental Health; Depression; Anxiety; Substance Abuse; Sexual behavior
14.  Antiretroviral Medication Adherence and Class-Specific Resistance in a Large Prospective Clinical Trial 
AIDS (London, England)  2010;24(3):395-403.
Objective
To assess the association between adherence to antiretroviral therapy and the presence of class-specific antiretroviral medication resistance.
Design
Secondary analysis of prospective clinical trial data
Methods
Participants randomized to the protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) strategies of the Community Programs for Clinical Research on AIDS (CPCRA) Flexible Initial Retrovirus Suppressive Therapies (FIRST) Study were included. Adherence was measured by 7-day self-report. Virological failure was defined as an HIV-RNA > 1000 at or after 4 months. The association between cumulative adherence and the development of class-specific genotypic resistance was assessed by Cox regression analysis.
Results
Included were 457 and 446 antiretroviral naïve participants on the PI and NNRTI strategies respectively. The median time to initial virological failure in the PI strategy was 1.2 years; 135 (30%) individuals failed with resistance. The median time to initial virological failure in the NNRTI strategy was 3.0 years; 127 (28%) failed with resistance. No association was found between cumulative adherence and PI resistance (HR 1.1, 95% CI 0.9 – 1.4 per 10% lower adherence). However, lower cumulative adherence was associated with an increased risk of NNRTI resistance at initial virological failure (HR 1.2, 95% CI 1.1 – 1.3 per 10% lower adherence). In both strategies lower cumulative adherence was associated with an increased risk of nucleoside reverse transcriptase inhibitor (NRTI) resistance at initial virological failure.
Conclusions
Adherence-resistance relationships are class-specific. For NRTIs and NNRTIs, initial virological failure with resistance is more likely at lower levels of cumulative adherence.
PMCID: PMC2886717  PMID: 20099399
adherence; antiretroviral therapy; HIV; virological failure; antiretroviral resistance
15.  Detection of Individuals with Acute HIV-1 Infection using the ARCHITECT® HIV Ag/Ab Combo Assay 
Background
We evaluated use of the ARCHITECT® HIV Ag/Ab Combo assay (HIV Combo; Abbott Diagnostics; available for sale outside of the U.S. only) for detection of acute HIV infection.
Methods
Samples were obtained from a behavioral intervention study (EXPLORE). HIV-uninfected men who have sex with men were enrolled and tested for HIV infection every 6 months. Samples from seroconverters collected at their last seronegative visit (n=217) were tested individually using two HIV RNA assays. Samples with detectable HIV RNA were classified as acute and were tested with HIV Combo. Samples from the enrollment visit (n=83) and the time of HIV seroconversion (n=219) were tested with HIV Combo as controls.
Results
Twenty-one (9.7%) samples from the last seronegative visit had detectable HIV RNA and were classified as acute. HIV Combo was positive for 13 (61.9%) of the acute samples. Samples not detected by HIV Combo had viral loads of 724 to 15,130 copies/ml. Expected results were obtained for positive and negative controls tested with HIV Combo.
Conclusions
HIV Combo detected nearly two-thirds of acute HIV infections identified in this high-risk population by non-pooled, HIV RNA assays. HIV Combo may be useful for high-throughput screening to identify individuals with acute HIV infection.
doi:10.1097/QAI.0b013e3181ab61e1
PMCID: PMC2744045  PMID: 19506484
acute infection; HIV-1; HIV Ag/Ab Combo assay
16.  Analysis of HIV Type 1 gp41 and Enfuvirtide Susceptibility among Men in the United States Who Were HIV Infected Prior to Availability of HIV Entry Inhibitors 
We analyzed HIV gp41 from 195 men in the United States who were HIV-1 infected between 1999 and 2002, before enfuvirtide (ENF) was approved for clinical use in the United States. gp41 genotyping results were obtained for 175 samples. None of the samples had major ENF resistance mutations. Six (3.4%) samples had minor ENF resistance mutations in the HR1 region (V38G, N43K, L44M, L45M). Twenty-eight (16%) samples had the N42S polymorphism, which is associated with ENF hypersusceptibility. Accessory mutations in the HR2 region were identified in some samples (E137K, S138A). Five of the six samples with HR1 resistance mutations were analyzed with a phenotypic assay; one sample had reduced ENF susceptibility (a sample with N42S + L44M + E137K). Prior to the availability of ENF, some men in the United States were infected with HIV that contained mutations associated with ENF resistance or hypersusceptibility. However, most of the mutations were not associated with phenotypic ENF resistance.
doi:10.1089/aid.2009.0014
PMCID: PMC2746939  PMID: 19552592
17.  Analysis of HIV Type 1 gp41 and Enfuvirtide Susceptibility among Men in the United States Who Were HIV Infected Prior to Availability of HIV Entry Inhibitors 
Abstract
We analyzed HIV gp41 from 195 men in the United States who were HIV-1 infected between 1999 and 2002, before enfuvirtide (ENF) was approved for clinical use in the United States. gp41 genotyping results were obtained for 175 samples. None of the samples had major ENF resistance mutations. Six (3.4%) samples had minor ENF resistance mutations in the HR1 region (V38G, N43K, L44M, L45M). Twenty-eight (16%) samples had the N42S polymorphism, which is associated with ENF hypersusceptibility. Accessory mutations in the HR2 region were identified in some samples (E137K, S138A). Five of the six samples with HR1 resistance mutations were analyzed with a phenotypic assay; one sample had reduced ENF susceptibility (a sample with N42S + L44M + E137K). Prior to the availability of ENF, some men in the United States were infected with HIV that contained mutations associated with ENF resistance or hypersusceptibility. However, most of the mutations were not associated with phenotypic ENF resistance.
doi:10.1089/aid.2009.0014
PMCID: PMC2746939  PMID: 19552592
18.  Prevalence of mood and anxiety disorders in women with systemic lupus erythematosus 
Arthritis and rheumatism  2009;61(6):822-829.
Objective
To examine the lifetime prevalence of mood and anxiety disorders in patients with SLE. Demographic and disease-related variables were examined for association with lifetime major depressive disorder and the presence of any mood or anxiety disorder.
Methods
Three-hundred and twenty-six Caucasian women with SLE completed the Composite International Diagnostic Interview (CIDI) and the Systemic Lupus Activity Questionnaire (SLAQ), a self-report measure of disease activity in SLE. The binomial test was used to compare the prevalence of psychiatric diagnoses in SLE patients to a population sample of Caucasian women.
Results
Sixty-five percent of participants received a lifetime mood or anxiety diagnosis. Major depressive disorder (47%), specific phobia (24%), panic disorder (16%), obsessive-compulsive disorder (9%), and bipolar I disorder (6%) were more common among the SLE patients compared to Caucasian women (p = 0.00009 for specific phobia, all other p values = 0.00001). Although most patients with histories of mood disorders reported their psychiatric symptoms to a medical provider, a substantial number of patients with anxiety disorders did not. Self-reported disease activity was associated with a lifetime history of major depression (p = 0.001) and presence of a mood or anxiety disorder (p = 0.001), after controlling for demographic and clinical characteristics.
Conclusion
Several mood and anxiety disorders are more common in women with SLE compared to the general population, and disease activity may contribute to this higher risk. Brief self-report questionnaires may help providers identify patients with these conditions, particularly when patients are reluctant to disclose their symptoms.
doi:10.1002/art.24519
PMCID: PMC2763591  PMID: 19479699
20.  Use of Non-Occupational Post-Exposure Prophylaxis does not Lead to an Increase in High Risk Sex Behaviors in Men Who have Sex with Men Participating in the EXPLORE Trial 
AIDS and Behavior  2010;14(5):1182-1189.
Non-occupational post-exposure prophylaxis (nPEP) use is an HIV prevention strategy that has been recommended by the CDC to prevent HIV infection after a high risk sexual exposure since 1997. In a behavioral intervention trial of 4,295 MSM we assessed perceptions and use of nPEP over 4 years in six cities across the United States. Overall, 1.9% of MSM reported use of nPEP prior to enrollment, and 6.3% at least once during the trial. Awareness of nPEP was reported by 47.5%, with higher awareness in two sites with funded nPEP programs. Three seroconversions occurred in the 384 visits where nPEP courses were reported, with no effect of nPEP on risk of HIV acquisition in this cohort (hazard ratio = 0.91, 95% confidence interval [0.29, 2.86]). NPEP users were a riskier group: increased odds of nPEP use were observed in association with multiple partners and unprotected receptive and insertive anal sex with HIV infected partners and partners with unknown HIV status. NPEP use was also associated with use of illicit drugs (injection drugs, crack cocaine, hallucinogens, and amphetamines). Importantly, willingness to use nPEP after high risk sex was associated with lower odds of high risk sex. After an episode of nPEP use, nPEP users remained more likely to report high risk sex than those in this cohort who had not previously used nPEP. However, within the subset of people who had previously reported high risk sex, previous nPEP use was not associated with higher odds of high risk sex, thus allaying fears that availability of nPEP would lead to an increase in high risk sex.
doi:10.1007/s10461-010-9712-1
PMCID: PMC2944957  PMID: 20490908
MSM; HIV; PEP; Behavioral disinhibition
21.  Disparities in Reported Reasons for Not Initiating or Stopping Antiretroviral Treatment Among a Diverse Sample of Persons Living with HIV 
BACKGROUND
Disparities in the use of antiretroviral therapy (ART) for HIV disease have been documented across race, gender, and substance use groups.
OBJECTIVE
The current analysis compares self-reported reasons for never taking or stopping ART among a diverse sample of men and women living with HIV.
DESIGN
Cross-sectional interview.
PARTICIPANTS
HIV + (N = 3,818) adults, 968 of whom reported discontinuing or never using ART.
MEASUREMANTS
Computerized self-administered and interviewer-administered self-reported demographic and treatment variables, including gender, race, ethnicity, CD4 count, detectable viral load, and reported reasons for not taking antiretroviral therapy.
RESULTS
Despite equivalent use of ART in the current sample, African-American respondents were 1.7 times more likely to report wanting to hide their HIV status and 1.7 times more likely to report a change in doctors/clinics as reasons for stopping ART (p = .049, and p = .042) and had odds 4.5 times those of non-African Americans of reporting waiting for viral marker counts to worsen (p = < .0001). There was a lower tendency (OR = 0.4) for women to endorse concerns of keeping their HIV status hidden as a reason for stopping ART compared to men (p = .003). Although those with an IDU history were less likely to be on ART, no differences in reasons for stopping or never initiating ART were found between those with and without an IDU history.
CONCLUSIONS
A desire to conceal HIV status as well as a change in doctors/clinics as reasons for discontinuing ART were considerably more common among African Americans, suggesting that perceived HIV/AIDS stigma is an obstacle to maintenance of treatment. Findings also indicate differences in reasons for stopping ART by gender and a perceived desire to wait for counts to worsen as a reason for not taking ART by African Americans, regardless of detectable viral load, CD4 count, age, education, employment, sexual orientation, and site.
doi:10.1007/s11606-008-0854-z
PMCID: PMC2628985  PMID: 19015925
HIV/AIDS; treatment disparities; gender; race; ethnicity; substance use
22.  Internalized Heterosexism among HIV-Positive Gay-Identified Men: Implications for HIV Prevention and Care 
Internalized heterosexism (IH), or the internalization of societal anti-homosexual attitudes, has been consistently linked to depression and low self-esteem among gay men, and inconclusively associated with substance use and sexual risk in gay and bisexual men. Using structural equation modeling, a model framed in Social Action Theory was tested in which IH is associated with HIV transmission risk and poor adherence to HIV antiretroviral therapy (ART) through the mechanisms of negative affect and stimulant use. Data from a sample of 465 gay-identified men interviewed as part of an HIV risk reduction behavioral trial were used to test the fit of the model. Results supported the hypothesized model in which IH was associated with unprotected receptive (but not insertive) anal intercourse with HIV-negative or unknown HIV status partners, and with ART non-adherence indirectly via increased negative affect and more regular stimulant use. The model accounted for 15% of the variance in unprotected receptive anal intercourse (URAI) and 17% of the variance in ART non-adherence. Findings support the potential utility of addressing IH in HIV prevention and treatment with HIV-positive gay men.
doi:10.1037/0022-006X.76.5.829
PMCID: PMC2801151  PMID: 18837600
HIV/AIDS; internalized heterosexism; homophobia; adherence; depression; methamphetamine; HIV transmission risk
23.  BREATHING VARIABILITY AT REST IS POSITIVELY ASSOCIATED WITH 24-HR BLOOD PRESSURE LEVEL 
American journal of hypertension  2008;21(12):1324-1329.
Background
Previous research has reported that inhibition of breathing can be observed in hypertensive patients at rest during the daytime, as well as in sleep at night. The present study hypothesized that the variability of breathing and end tidal CO2 (PetCO2) in seated women at rest is positively associated with their 24-hr blood pressure level.
Methods
Breath-to-breath measures of breathing rate and tidal volume were recorded via inductive plethysmography in each of 54 women during two 20 min sessions of seated rest, and in 32 women during nighttime sleep. PetCO2 was also recorded during these sessions via a respiratory gas monitor. Ambulatory blood pressure was recorded for 24 hr between the two clinic sessions via oscillometry.
Results
Breath pauses > 10 sec were observed significantly more often in women in the upper than the lower tertile of 24-hr systolic blood pressure. Breath-to-breath variability in breathing rate, tidal volume, and minute ventilation were greater in the higher blood pressure tertile women. Variability in PetCO2 was also greater in high blood pressure tertile. These associations were independent of age, weight, and body surface area. Breathing variability was inversely correlated with heart rate variability.
Conclusion
Greater variability in breathing at rest that is independent of metabolic activity characterizes women with elevated blood pressure. The linear association of breathing variability with 24-hr blood pressure level is consistent with the hypothesis that intermittent breathing inhibition may predispose to the development of some forms of hypertension.
doi:10.1038/ajh.2008.292
PMCID: PMC2752321  PMID: 18820654
Apnea; blood pressure; breathing; end tidal CO2; hypertension
24.  Depressive Symptoms, Utilization of Mental Health Care, Substance Use and Sexual Risk Among Young Men Who have Sex with Men in EXPLORE: Implications for Age-Specific Interventions 
AIDS and behavior  2008;13(4):811-821.
The EXPLORE study evaluated a behavioral intervention to prevent HIV infection among MSM. We examined depressive symptoms, utilization of mental health care, substance use and HIV risk taking behaviors in YMSM aged 16–25 years compared with their older counterparts. YMSM were more likely to report depressive symptoms (OR = 1.55) and less likely to report use of counseling (OR = 0.39) or medication (OR = 0.20) for psychiatric conditions. YMSM were more likely to report heavy alcohol and drug use. YMSM more often reported engaging in unprotected insertive (OR = 1.60) and receptive (OR = 2.07) anal intercourse with presumed HIV-uninfected partners, and unprotected receptive (OR = 1.72) anal intercourse with partners of unknown-HIV status. These findings suggest the need for more appropriate and accessible mental health care and substance use services for YMSM. Additionally, HIV prevention work with this population should provide comprehensive education about HIV testing and risk reduction counseling that focuses on communication about serostatus and safety in sexual situations.
doi:10.1007/s10461-008-9439-4
PMCID: PMC2718068  PMID: 18709453
MSM; HIV; Young men; Mental health; Substance use; Sexual behavior
25.  The Need for Attention to Dose in Mind–Body Interventions: Lessons from T'ai Chi Clinical Trials 
Abstract
Objective
The rise in popularity of complementary and alternative medicine (CAM) in the United States has stimulated increasing interest in researching CAM. One challenge to this research is determining the optimal dose of a CAM intervention. T'ai Chi Chuan (TCC) has received considerable attention as a mind–body practice; however, it remains unclear exactly how much TCC practice is necessary to elicit a discernable effect.
Design
In this review, we selected 19 studies and examined the variation in the number and length of training sessions. Secondary and tertiary aims include examining attendance rates for each intervention and the instructions given to participants regarding home-based practice. The degree to which investigators monitored participants' home-based practice was also examined.
Results
In the intent-to-treat analyses, the median time of TCC practice was 2877 minutes intended for participants across the selected interventions. Fourteen (14) of the publications provided information about participant attendance in the original publication, 2 provided additional information through further author inquiry, and 3 commented on TCC practice outside of the structured class environment through author inquiry.
Conclusions
The data reported are inconsistent in reported attendance and home-based practice rates, making it difficult to speculate on the relationship between the amount of TCC and intervention effects. Further research could contribute to this area by determining the optimal dose of TCC instruction.
doi:10.1089/acm.2007.0680
PMCID: PMC3154051  PMID: 18684072

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