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1.  Assessment, Diagnosis, and Treatment of HIV-Associated Neurocognitive Disorder: A Consensus Report of the Mind Exchange Program 
Based on evidence from a literature search and consensus expert opinion, the Mind Exchange program provides practical guidance in the diagnosis, ongoing monitoring, and treatment of HIV-associated neurocognitive disorder that is of direct relevance to daily practice.
Many practical clinical questions regarding the management of human immunodeficiency virus (HIV)–associated neurocognitive disorder (HAND) remain unanswered. We sought to identify and develop practical answers to key clinical questions in HAND management. Sixty-six specialists from 30 countries provided input into the program, which was overseen by a steering committee. Fourteen questions were rated as being of greatest clinical importance. Answers were drafted by an expert group based on a comprehensive literature review. Sixty-three experts convened to determine consensus and level of evidence for the answers. Consensus was reached on all answers. For instance, good practice suggests that all HIV patients should be screened for HAND early in disease using standardized tools. Follow-up frequency depends on whether HAND is already present or whether clinical data suggest risk for developing HAND. Worsening neurocognitive impairment may trigger consideration of antiretroviral modification when other causes have been excluded. The Mind Exchange program provides practical guidance in the diagnosis, monitoring, and treatment of HAND.
doi:10.1093/cid/cis975
PMCID: PMC3657494  PMID: 23175555
AIDS dementia complex; HIV-associated dementia (HAD); HIV-associated neurocognitive disorder (HAND); HIV encephalopathy; neurocognitive impairment
2.  Clinician Practices and Attitudes Regarding Early Antiretroviral Therapy in the US 
Background
Use of antiretroviral therapy (ART) to prevent HIV transmission has received substantial attention following a recent trial demonstrating efficacy of ART to reduce HIV transmission in HIV-discordant couples.
Objective
To assess practices and attitudes of HIV clinicians regarding early initiation of ART for treatment and prevention of HIV at sites participating in the HPTN 065 study.
Design
Cross-sectional internet-based survey.
Methods
ART-prescribing clinicians (n=165 physicians, nurse-practitioners, physician assistants) at 38 HIV care sites in Bronx, NY and Washington, DC completed a brief anonymous internet survey, prior to any participation in the HPTN 065 study. Analyses included associations between clinician characteristics and willingness to prescribe ART for prevention.
Results
Almost all respondents (95%), of whom 59% were female, 66% white and 77% HIV specialists, “strongly agreed/agreed” that early ART can decrease HIV transmission. Fifty-six percent currently recommend ART initiation for HIV-infected patients with CD4+ count ≤500 cells/mm3, and 14 percent indicated that they initiate ART irrespective of CD4+ count. Most (75%) indicated that they would consider initiating ART earlier than otherwise indicated for patients in HIV-discordant sexual partnerships, and 40% would do so if a patient was having unprotected sex with a partner of unknown HIV status. There were no significant differences by age, gender, or clinician type in likelihood of initiating ART for reasons including HIV transmission prevention to sexual partners.
Conclusions
This sample of US clinicians indicated support for early ART initiation to prevent HIV transmission, especially for situations where such transmission would be more likely to occur.
doi:10.1097/QAI.0b013e31826a184c.
PMCID: PMC3957230  PMID: 23183150
HIV prevention; early antiretroviral therapy; test and treat; clinician survey
3.  Daily Oral Emtricitabine/Tenofovir Preexposure Prophylaxis and Herpes Simplex Virus Type 2 among Men Who Have Sex with Men 
PLoS ONE  2014;9(3):e91513.
Background
In addition to protecting against HIV acquisition, antiretroviral preexposure prophylaxis (PrEP) using topical 1% tenofovir gel reduced Herpes simplex virus type 2 (HSV-2) acquisition by 51% among women in the CAPRISA 004 study. We examined the effect of daily oral emtricitabine/tenofovir (FTC/TDF) PrEP on HSV-2 seroincidence and ulcer occurrence among men who have sex with men (MSM) in the iPrEx trial.
Methods
HSV-2 serum testing was performed at screening and every six months. Among HSV-2-seronegative individuals, we used Cox regression models to estimate hazard ratios (HRs) of HSV-2 seroincidence associated with randomization to FTC/TDF. We used multiple imputation and Cox regression to estimate HRs for HSV-2 seroincidence accounting for drug exposure. We assessed ulcer occurrence among participants with prevalent or incident HSV-2 infection.
Results
Of the 2,499 participants, 1383 (55.3%) tested HSV-2-seronegative at baseline, 892 (35.7%) tested positive, 223 (8.9%) had indeterminate tests, and one test was not done. Of the 1,347 HSV-2-seronegative participants with follow-up, 125 (9.3%) had incident HSV-2 infection (5.9 per 100 person-years). Compared with participants receiving placebo, there was no difference in HSV-2 seroincidence among participants receiving FTC/TDF (HR 1.1, 95% CI: 0.8–1.5; P = 0.64) or among participants receiving FTC/TDF with a concentration of tenofovir diphosphate >16 per million viable cells (HR 1.0, 95% CI: 0.3–3.5; P = 0.95). Among participants with HSV-2 infection, the proportion with ≥1 moderate or severe ulcer adverse event was twice as high in the placebo vs. active arm (5.9% vs. 2.9%, P = 0.02), but there were no differences in the proportions with ≥1 clinical examination during which perianal or groin ulcers were identified.
Conclusions
Tenofovir in daily oral FTC/TDF PrEP may reduce the occurrence of ulcers in individuals with HSV-2 infection but does not protect against HSV-2 incidence among MSM.
doi:10.1371/journal.pone.0091513
PMCID: PMC3956614  PMID: 24637511
4.  Walking the line: Stimulant use during sex and HIV risk behavior among Black urban MSM 
Drug and alcohol dependence  2010;110(0):30-37.
Background
Although the association of stimulant use to sexual risk taking and HIV transmission has been well documented among white gay men, stimulant use during sex continues to be under-explored among Black men who have sex with men (MSM).
Methods
Black MSM (n = 197) recruited via modified respondent-driven sampling between January and July 2008 completed an interviewer-administered quantitative assessment and optional HIV counseling and testing. Bivariate logistic regression procedures were employed to examine the association of demographics, sexual risk, and other psychosocial factors with stimulant use (at least monthly during sex in the past 12 months). Variable elimination using the backward selection process was used to fit two separate final multivariable logistic regression models examining stimulant use as the outcome and HIV sexual risk in the past 12 months by gender as the primary predictor: (1) Model 1: HIV sexual risk behavior with a casual male sex partner as a primary, forced predictor; (2) Model 2: HIV sexual risk behavior with a female sex partner as primary, forced predictor.
Results
One-third (34%) of Black MSM reported using stimulants monthly or more frequently during sex in the past 12 months. The following factors were independently associated with stimulant use during sex: (1) Model 1: unprotected anal sex with a casual male sex partner in the past 12 months (AOR = 2.61; 95% CI = 1.06–6.42; p = 0.01), older age (AOR = 1.09; 95% CI = 1.05–1.15; p < 0.001), erectile dysfunction (ED) medication use monthly or more during sex in the past 12 months (AOR = 7.81; 95% CI = 1.46–41.68; p = 0.02), problematic alcohol use (AOR = 3.31; 95% CI = 1.312–8.38; p = 0.005), and higher HIV treatment optimism (AOR = 0.86; 95% CI = 0.76–0.97; p = 0.01). (2) Model 2: unprotected vaginal or anal sex with a female partner in the past 12 months (AOR = 3.54; 95% CI = 1.66–7.56; p = 0.001), older age (AOR = 1.10; 95% CI = 1.05–1.14; p < 0.001), ED use monthly or more during sex in the past 12 months (AOR = 3.70; 95% CI = 1.13–12.13; p = 0.03), clinically significant depressive symptoms (CES-D) at the time of study enrollment (AOR = 3.11; 95% CI = 1.45–6.66; p = 0.004), and supportive condom use norms (AOR = 0.69; 95% CI = 0.49–0.97; p = 0.03).
Conclusion
Frequent stimulant use is an important factor in HIV and STD sexual risk among Black MSM, particularly for older men and those with co-occurring psychosocial morbidities. HIV and STD prevention interventions in this population may benefit from addressing the precipitants of stimulant use and sexual risk taking.
doi:10.1016/j.drugalcdep.2010.01.017
PMCID: PMC3947405  PMID: 20334986
Stimulant use; Black; MSM; HIV; Sexual risk behavior
5.  Clinically Significant Depressive Symptoms as a Risk Factor for HIV Infection Among Black MSM in Massachusetts 
AIDS and behavior  2009;13(4):798-810.
High rates of depression have been observed among men who have sex with men (MSM) relative to the general adult male population; however, a dearth of research has explored depression among Black MSM. Black MSM (n = 197) recruited via modified respondent-driven sampling between January and July 2008 completed an interviewer-administered quantitative assessment and voluntary HIV counseling and testing. Bivariate and multivariable logistic regression procedures examined the associations of demographics, behavioral HIV risk factors, and psychosocial variables with depressive symptoms by severity, using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Adjusting for demographic and behavioral variables, significant factors associated with (1) clinically significant depressive symptoms (33%; CES-D score ≥ 16): being publicly insured by Medicaid, having serodiscordant anal sex with a casual male partner, and being diagnosed with an STD in the prior 12 months; (2) moderate depressive symptoms (19%; CES-D score 16–26): having serodiscordant unprotected anal sex with a casual male partner and being diagnosed with an STD in the prior 12 months; (3) severe depressive symptoms (14%; CES-D score 27+): being publicly insured by Medicaid and reporting difficulty accessing healthcare in the past 12 months. Moderately depressed Black MSM may be more likely to engage in behaviors that place them at increased risk for HIV and other STDs. HIV prevention interventions for Black MSM may benefit from incorporating screening and/or treatment for depression, allowing MSM who are depressed to respond more effectively to behavioral change approaches.
doi:10.1007/s10461-009-9571-9
PMCID: PMC3947411  PMID: 19462228
MSM; Depression; African American; HIV; STD
6.  Project Enhance: A Randomized Controlled Trial of an Individualized HIV Prevention Intervention for HIV-Infected Men Who Have Sex With Men Conducted in a Primary Care Setting 
Objective
Men who have sex with men (MSM) are the largest group of individuals in the U.S. living with HIV and have the greatest number of new infections. This study was designed to test a brief, culturally relevant prevention intervention for HIV-infected MSM, which could be integrated into HIV care.
Method
HIV-infected MSM who received HIV care in a community health center (N = 201), and who reported HIV sexual transmission-risk behavior (TRB) in the prior 6 months, were randomized to receive the intervention or treatment as usual. The intervention, provided by a medical social worker, included proactive case management for psychosocial problems, counseling about living with HIV, and HIV TRB risk reduction. Participants were followed every 3 months for one year.
Results
Participants, regardless of study condition, reported reductions in HIV TRB, with no significant differential effect by condition in primary intent-to-treat analyses. When examining moderators, the intervention was differentially effective in reducing HIV TRB for those who screened in for baseline depression, but this was not the case for those who did not screen in for depression.
Conclusions
The similar level of reduction in HIV TRB in the intervention and control groups, consistent with other recent secondary prevention interventions, speaks to the need for new, creative designs, or more potent interventions in secondary HIV prevention trials, as the control group seemed to benefit from risk assessment, study contact, and referrals provided by study staff. The differential finding for those with depression may suggest that those without depression could reap benefits from limited interventions, but those with a comorbid psychiatric diagnosis may require additional interventions to modify their sexual risk behaviors.
doi:10.1037/a0028581
PMCID: PMC3651590  PMID: 22746262
MSM; HIV prevention; AIDS/HIV; high-risk sexual behavior; depression
7.  Concomitant Socioeconomic, Behavioral, and Biological Factors Associated with the Disproportionate HIV Infection Burden among Black Men Who Have Sex with Men in 6 U.S. Cities 
PLoS ONE  2014;9(1):e87298.
Background
American Black men who have sex with men (MSM) are disproportionately affected by HIV, but the factors associated with this concentrated epidemic are not fully understood.
Methods
Black MSM were enrolled in 6 US cities to evaluate a multi-component prevention intervention, with the current analysis focusing on the correlates of being newly diagnosed with HIV compared to being HIV-uninfected or previously diagnosed with HIV.
Results
HPTN 061 enrolled 1553 Black MSM whose median age was 40; 30% self-identified exclusively as gay or homosexual, 29% exclusively as bisexual, and 3% as transgender. About 1/6th (16.2%) were previously diagnosed with HIV (PD); of 1263 participants without a prior HIV diagnosis 7.6% were newly diagnosed (ND). Compared to PD, ND Black MSM were younger (p<0.001); less likely to be living with a primary partner (p<0.001); more likely to be diagnosed with syphilis (p<0.001), rectal gonorrhea (p = 0.011) or chlamydia (p = 0.020). Compared to HIV-uninfected Black MSM, ND were more likely to report unprotected receptive anal intercourse (URAI) with a male partner in the last 6 months (p<0.001); and to be diagnosed with syphilis (p<0.001), rectal gonorrhea (p = 0.004), and urethral (p = 0.025) or rectal chlamydia (p<0.001). They were less likely to report female (p = 0.002) or transgender partners (p = 0.018). Multivariate logistic regression analyses found that ND Black MSM were significantly more likely than HIV-uninfected peers to be unemployed; have STIs, and engage in URAI. Almost half the men in each group were poor, had depressive symptoms, and expressed internalized homophobia.
Conclusions
ND HIV-infected Black MSM were more likely to be unemployed, have bacterial STIs and engage in URAI than other Black MSM. Culturally-tailored programs that address economic disenfranchisement, increase engagement in care, screen for STIs, in conjunction with safer sex prevention interventions, may help to decrease further transmission in this heavily affected community.
doi:10.1371/journal.pone.0087298
PMCID: PMC3909083  PMID: 24498067
8.  The Promise of Antiretrovirals for HIV Prevention 
With an estimated 2.6 million new HIV infections diagnosed annually, the world needs new prevention strategies to partner with condom use, harm reduction approaches for injection drug users, and male circumcision. Antiretrovirals can reduce the risk of mother-to-child HIV transmission and limit HIV acquisition after occupational exposure. Macaque models and clinical trials demonstrate efficacy of oral or topical antiretrovirals used prior to HIV exposure to prevent HIV transmission, ie pre-exposure prophylaxis (PrEP). Early initiation of effective HIV treatment in serodiscordant couples results in a 96% decrease in HIV transmission. HIV testing to determine serostatus and identify undiagnosed persons is foundational to these approaches. The relative efficacy of different approaches, adherence, cost and long-term safety will affect uptake and impact of these strategies. Ongoing research will help characterize the role for oral and topical formulations and help quantify potential benefits in sub-populations at risk for HIV acquisition.
doi:10.1007/s11908-012-0242-z
PMCID: PMC3901012  PMID: 22351302
HIV prevention; Pre-exposure prophylaxis; Microbicide; Tenofovir; Emtricitabine
9.  Short Communication: New HIV Infections at Southern New England Academic Institutions: Implications for Prevention 
Abstract
New HIV infections among younger men who have sex with men (MSM) in the United States are escalating. Data on HIV infections in college students are limited. In 2010, three MSM college students presented to our clinic with primary HIV infection (PHI) in a single month. To determine the number of college students among new HIV diagnoses, we reviewed clinical characteristics and molecular epidemiology of HIV-diagnosed individuals from January to December 2010 at the largest HIV clinic in Southern New England. PHI was defined as acute HIV infection or seroconversion within the last 6 months. Of 66 individuals diagnosed with HIV in 2010, 62% were MSM and 17% were academic students (12% college or university, 5% other). Seventy-three percent of students were MSM. Compared to nonstudents, students were more likely to be younger (24 versus 39 years), born in the United States (91% versus 56%), have another sexually transmitted disease (45% versus 11%), and present with PHI (73% versus 16%, all p-values<0.05). Thirty percent of individuals formed eight transmission clusters including four students. MSM were more likely to be part of clusters. Department of Health contact tracing of cluster participants allowed further identification of epidemiological linkages. Given these high rates of PHI in recently diagnosed students, institutions of higher education should be aware of acute HIV presentation and the need for rapid diagnosis. Prevention strategies should focus on younger MSM, specifically college-age students who may be at increased risk of HIV infection.
doi:10.1089/aid.2012.0130
PMCID: PMC3537304  PMID: 22724920
10.  Anxiety Specific Pathways to HIV Sexual Transmission Risk Behavior among Young Gay and Bisexual Men 
This study evaluated whether specific anxiety disorders increased the likelihood of sexual transmission risk behavior (TRB) in younger (ages 20–29) versus older (ages 30+) HIV positive gay and bisexual men. Participants completed screening measures for Posttraumatic Stress Disorder (PTSD), Social Phobia, and Panic Disorder, and an assessment of recent TRB Moderated regression analyses indicated that PTSD was associated with greater risk of TRB in younger but not older men, independent of HIV disease stage or treatment status. Efficacy of secondary HIV prevention efforts for younger men may be augmented by addressing the context of trauma history and consequent mental health issues.
doi:10.1080/19359705.2012.755142
PMCID: PMC3752916  PMID: 23997845
HIV; age; post-traumatic stress disorder; sexual transmission risk behavior
11.  Performance of a Limiting-Antigen Avidity Enzyme Immunoassay for Cross-Sectional Estimation of HIV Incidence in the United States 
PLoS ONE  2013;8(12):e82772.
Background
A limiting antigen avidity enzyme immunoassay (HIV-1 LAg-Avidity assay) was recently developed for cross-sectional HIV incidence estimation. We evaluated the performance of the LAg-Avidity assay alone and in multi-assay algorithms (MAAs) that included other biomarkers.
Methods and Findings
Performance of testing algorithms was evaluated using 2,282 samples from individuals in the United States collected 1 month to >8 years after HIV seroconversion. The capacity of selected testing algorithms to accurately estimate incidence was evaluated in three longitudinal cohorts. When used in a single-assay format, the LAg-Avidity assay classified some individuals infected >5 years as assay positive and failed to provide reliable incidence estimates in cohorts that included individuals with long-term infections. We evaluated >500,000 testing algorithms, that included the LAg-Avidity assay alone and MAAs with other biomarkers (BED capture immunoassay [BED-CEIA], BioRad-Avidity assay, HIV viral load, CD4 cell count), varying the assays and assay cutoffs. We identified an optimized 2-assay MAA that included the LAg-Avidity and BioRad-Avidity assays, and an optimized 4-assay MAA that included those assays, as well as HIV viral load and CD4 cell count. The two optimized MAAs classified all 845 samples from individuals infected >5 years as MAA negative and estimated incidence within a year of sample collection. These two MAAs produced incidence estimates that were consistent with those from longitudinal follow-up of cohorts. A comparison of the laboratory assay costs of the MAAs was also performed, and we found that the costs associated with the optimal two assay MAA were substantially less than with the four assay MAA.
Conclusions
The LAg-Avidity assay did not perform well in a single-assay format, regardless of the assay cutoff. MAAs that include the LAg-Avidity and BioRad-Avidity assays, with or without viral load and CD4 cell count, provide accurate incidence estimates.
doi:10.1371/journal.pone.0082772
PMCID: PMC3873916  PMID: 24386116
12.  No Evidence of Sexual Risk Compensation in the iPrEx Trial of Daily Oral HIV Preexposure Prophylaxis 
PLoS ONE  2013;8(12):e81997.
Objective
Preexposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) reduced HIV acquisition in the iPrEx trial among men who have sex with men and transgender women. Self-reported sexual risk behavior decreased overall, but may be affected by reporting bias. We evaluated potential risk compensation using biomarkers of sexual risk behavior.
Design and methods
Sexual practices were assessed at baseline and quarterly thereafter; perceived treatment assignment and PrEP efficacy beliefs were assessed at 12 weeks. Among participants with ≥1 follow-up behavioral assessment, sexual behavior, syphilis, and HIV infection were compared by perceived treatment assignment, actual treatment assignment, and perceived PrEP efficacy.
Results
Overall, acute HIV infection and syphilis decreased during follow-up. Compared with participants believing they were receiving placebo, participants believing they were receiving FTC/TDF reported more receptive anal intercourse partners prior to initiating drug (12.8 vs. 7.7, P = 0.04). Belief in receiving FTC/TDF was not associated with an increase in receptive anal intercourse with no condom (ncRAI) from baseline through follow-up (risk ratio [RR] 0.9, 95% confidence interval [CI]: 0.6–1.4; P = 0.75), nor with a decrease after stopping study drug (RR 0.8, 95% CI: 0.5–1.3; P = 0.46). In the placebo arm, there were trends toward lower HIV incidence among participants believing they were receiving FTC/TDF (incidence rate ratio [IRR] 0.8, 95% CI: 0.4–1.8; P = 0.26) and also believing it was highly effective (IRR 0.5, 95% CI: 0.1–1.7; P = 0.12).
Conclusions
There was no evidence of sexual risk compensation in iPrEx. Participants believing they were receiving FTC/TDF had more partners prior to initiating drug, suggesting that risk behavior was not a consequence of PrEP use.
doi:10.1371/journal.pone.0081997
PMCID: PMC3867330  PMID: 24367497
13.  Tuberculosis in Pregnant and Postpartum Women: Epidemiology, Management, and Research Gaps 
Tuberculosis peaks during a woman's reproductive years and is a leading cause of maternal mortality. We review the epidemiology, screening, treatment, and outcomes of tuberculosis in pregnancy and postpartum, and highlight research gaps.
Tuberculosis is most common during a woman's reproductive years and is a major cause of maternal–child mortality. National guidelines for screening and management vary widely owing to insufficient data. In this article, we review the available data on (1) the global burden of tuberculosis in women of reproductive age; (2) how pregnancy and the postpartum period affect the course of tuberculosis; (3) how to screen and diagnose pregnant and postpartum women for active and latent tuberculosis; (4) the management of active and latent tuberculosis in pregnancy and the postpartum period, including the safety of tuberculosis medications; and (5) infant outcomes. We also include data on HIV/tuberculosis coinfection and drug-resistant tuberculosis. Finally, we highlight research gaps in tuberculosis in pregnant and postpartum women.
doi:10.1093/cid/cis732
PMCID: PMC3491857  PMID: 22942202
14.  Drug Use and Other Risk Factors Related to Lower Body Mass Index among HIV-Infected Individuals 
Drug and alcohol dependence  2008;95(0):10.1016/j.drugalcdep.2007.12.004.
Malnutrition is associated with morbidity and mortality in HIV infected individuals. Little research has been conducted to identify the roles that clinical, illicit drug use and socioeconomic characteristics play in the nutritional status of HIV-infected patients. This cross-sectional analysis included 562 HIV-infected participants enrolled in the Nutrition for Healthy Living study conducted in Boston, MA and Providence, RI. The relationship between body mass index (BMI) and several covariates (type of drug use, demographic, and clinical characteristics) were examined using linear regression.
Overall, drug users had a lower BMI than non-drug users. The BMI of cocaine users was 1.4 kg/m2 less than that of patients who did not use any drugs, after adjusting for other covariates (p= 0.02). The BMI of participants who were over the age of 55 years was 2.0 kg/m2 less than that of patients under the age of 35, and BMI increased by 0.3 kg/m2 with each 100 cells/mm3 increase in CD4 count. HAART use, adherence to HAART, energy intake, AIDS status, hepatitis B and hepatitis C co-infections, cigarette smoking and depression were not associated with BMI in the final model.
In conclusion, BMI was lower in drug users than non-drug users, and was lowest in cocaine users. BMI was also directly associated with CD4 count and inversely related to age more than 55 years old. HIV infected cocaine users may be at higher risk of developing malnutrition, suggesting the need for anticipatory nutritional support.
doi:10.1016/j.drugalcdep.2007.12.004
PMCID: PMC3837518  PMID: 18243579
drug users; cocaine users; BMI; HIV; CD4 count
15.  Balancing Immunological Benefits and Cardiovascular Risks of Antiretroviral Therapy: When Is Immediate Treatment Optimal? 
Immediate treatment initiation is optimal for patients aged <30 years regardless of CD4 count under a wide range of assumptions about treatment benefits and harms, whereas the timing of initiation at older ages depends on the assumed magnitude of the cardiovascular risk from treatment and patient preferences toward treatment.
We developed a mathematical model to identify the timing of antiretroviral therapy (ART) initiation that optimizes patient outcomes as a function of patient CD4 count, age, cardiac mortality risk, sex, and personal preferences. Our goal was to find the conditions that maximize patient quality-adjusted life expectancy (QALE) in the context of our model. Under the assumption that ART confers disease progression and mortality benefits at any CD4 count, immediate treatment initiation yields the greatest remaining QALE for young patients under most circumstances. The timing of ART initiation depends on the magnitude of benefit from ART at high CD4 counts, the magnitude of increases in cardiac risk, and patients' preferences. If ART reduces HIV progression at high CD4 counts, immediate ART is preferable for most newly infected individuals <35 years even if ART doubles age- and sex-specific cardiac risk.
doi:10.1093/cid/cis731
PMCID: PMC3478144  PMID: 22942203
16.  Genotypic HIV type-1 drug resistance among patients with immunological failure to first-line antiretroviral therapy in south India 
Antiviral therapy  2009;14(7):10.3851/IMP1411.
Background
HIV type-1 (HIV-1) monitoring in resource limited settings relies on clinical and immunological assessment. The objective of this study was to study the frequency and pattern of reverse transcriptase (RT) drug resistance among patients with immunological failure (IF) to first-line therapy.
Methods
A cross-sectional study of 228 patients with IF was done, of which 126 were drug-naive (group A) when starting highly active antiretroviral therapy (HAART) and 102 were exposed to mono/dual therapy prior to HAART initiation (group B). A validated in-house genotyping method and Stanford interpretaion was used. Means, sd, median and frequencies (as percentages) were used to indicate the patient characteristics in each group. The χ2 test and Fisher's exact test were used to compare categorical variables as appropriate. All analyses were performed using SPSS software, version 13.0. P-values <0.05 were considered to be statistically significant.
Results
RT drug resistance mutations were found in 92% and 96% of patients in groups A and B, respectively. Median (interquartile range) CD4+ T–cell count at failure was 181cells/ml (18–999) and time to failure was 40 months (2–100). M184V (80% versus 75%), thymidine analogue mutations (63% versus 74%), Y181C (39% versus 39%) and K103N (29% versus 39%) were predominant RT mutations in both groups. Extensive nucleoside reverse transcriptase inhibitor cross-resistance mutations were observed in 51% and 26%of patients in group B and A, respectively.
Conclusions
Alternative strategies for initial therapy and affordable viral load monitoring could reduce resistance accumulations and preserve available drugs for future options in resource-limited settings.
doi:10.3851/IMP1411
PMCID: PMC3816397  PMID: 19918105
17.  A Pilot Trial of Integrated Behavioral Activation and Sexual Risk Reduction Counseling for HIV-Uninfected Men Who Have Sex with Men Abusing Crystal Methamphetamine 
AIDS Patient Care and STDs  2012;26(11):681-693.
Abstract
Crystal methamphetamine use is a major driver behind high-risk sexual behavior among men who have sex with men (MSM). Prior work suggests a cycle of continued crystal methamphetamine use and high-risk sex due to loss of the ability to enjoy other activities, which appears to be a side effect of this drug. Behavioral activation (BA) is a treatment for depression that involves learning to reengage in life's activities. We evaluated a novel intervention for crystal methamphetamine abuse and high-risk sex in MSM, incorporating 10 sessions of BA with integrated HIV risk reduction counseling (RR). Forty-four subjects were screened, of whom 21 met initial entry criteria. A total of 19 participants enrolled; 16 completed an open-phase study of the intervention. Behavioral assessments were conducted at baseline, 3 months postbaseline, and 6 months postbaseline. Linear mixed effects regression models were fit to assess change over time. Mean unprotected anal intercourse (UAI) episodes decreased significantly from baseline to acute postintervention (β=−4.86; 95% confidence interval [CI]=−7.48, −2.24; p=0.0015) and from baseline to 6 months postbaseline (β=−5.07; 95% CI=−7.85, −2.29; p=0.0017; test of fixed effects χ2=16.59; df=2,13; p=0.0002). On average, there was a significant decrease over time in the number of crystal methamphetamine episodes in the past 3 months (χ2=22.43; df=2,15; p<0.0001), and the number of days of crystal methamphetamine use in the past 30 days (χ2=9.21; df=2,15; p=0.010). Statistically significant reductions in depressive symptoms and poly-substance use were also maintained. Adding behavioral activation to risk reduction counseling for MSM with problematic crystal methamphetamine use may augment the potency of a risk reduction intervention for this population. Due to the small sample size and time intensive intervention, future testing in a randomized design is necessary to determine efficacy, with subsequent effectiveness testing.
doi:10.1089/apc.2012.0216
PMCID: PMC3495110  PMID: 23030605
18.  The Rising Challenge of Non–AIDS-Defining Cancers in HIV-Infected Patients 
In the post–highly active combination antiretroviral therapy era, human immunodeficiency virus (HIV)-infected patients are facing high rates of so–called non–AIDS–defining cancers. The challenge facing clinicians caring for HIV patients is how best to screen, treat, and prevent these cancers.
Since the advent of HAART, patients with HIV infection have seen a significant improvement in their morbidity, mortality, and life expectancy. The incidence of AIDS-defining illnesses, including AIDS-defining malignancies, has been on the decline. However, deaths due to non–AIDS-defining illnesses have been on the rise. These so-called non–AIDS-defining cancers (NADCs) include cancers of the lung, liver, kidney, anus, head and neck, and skin, as well as Hodgkin's lymphoma. It is poorly understood why this higher rate of NADCs is occurring. The key challenge facing oncologists is how to administer chemotherapy effectively and safely to patients on antiretroviral therapy. The challenge to clinicians caring for HIV-infected patients is to develop and implement effective means to screen, treat, and prevent NADCs in the future. This review presents data on the epidemiology and etiology of NADCs, as well as ongoing research into this evolving aspect of the HIV epidemic.
doi:10.1093/cid/cis613
PMCID: PMC3529613  PMID: 22776851
19.  Engaging Healthcare Providers to Implement HIV Pre-Exposure Prophylaxis 
Current opinion in HIV and AIDS  2012;7(6):593-599.
Purpose of review
Recent randomized controlled trials have demonstrated that HIV Pre-Exposure Prophylaxis (PrEP) can decrease HIV incidence among several at-risk populations, including men who have sex with men, serodiscordant couples, and heterosexual men and women. As PrEP is a biomedical intervention that requires clinical monitoring and a high level of medication adherence, maximizing the public health effectiveness of PrEP in real-world settings will require the training of a cadre of healthcare providers to prescribe PrEP. Therefore it is critical to understand provider knowledge, practices and attitudes towards PrEP prescribing, and to develop strategies for engaging and training providers to provide PrEP.
Recent findings
A limited number of studies have focused on PrEP implementation by healthcare providers. These studies suggest that some providers are knowledgeable about PrEP, but many are not, or express misgivings. Although many clinicians report willingness to provide PrEP, few have prescribed PrEP in clinical practice. Provider comfort and skills in HIV risk assessment are suboptimal, which could limit identification of individuals who are most likely to benefit from PrEP use.
Summary
Further studies to understand facilitators and barriers to HIV risk assessment and PrEP prescribing by practicing clinicians are needed. Innovative training strategies and decision-support interventions for providers could optimize PrEP implementation and therefore merit additional research.
doi:10.1097/COH.0b013e3283590446
PMCID: PMC3769645  PMID: 23032736
HIV; Prevention; Pre-Exposure Prophylaxis; Provider; Implementation
21.  A call to action for comprehensive HIV services for men who have sex with men 
Lancet  2012;380(9839):424-438.
Where surveillance has been done, it has shown that men (MSM) who have sex with men bear a disproportionate burden of HIV. Yet they continue to be excluded, sometimes systematically, from HIV services because of stigma, discrimination, and criminalisation. This situation must change if global control of the HIV epidemic is to be achieved. On both public health and human rights grounds, expansion of HIV prevention, treatment, and care to MSM is an urgent imperative. Effective combination prevention and treatment approaches are feasible, and culturally competent care can be developed, even in rights-challenged environments. Condom and lubricant access for MSM globally is highly cost effective. Antiretroviral-based prevention, and antiretroviral access for MSM globally, would also be cost effective, but would probably require substantial reductions in drug costs in high-income countries to be feasible. To address HIV in MSM will take continued research, political will, structural reform, community engagement, and strategic planning and programming, but it can and must be done.
doi:10.1016/S0140-6736(12)61022-8
PMCID: PMC3805059  PMID: 22819663
22.  Antiretrovirals for HIV Prevention: New Steps Forward and New Questions 
Annals of internal medicine  2012;156(4):312-314.
doi:10.7326/0003-4819-156-4-201202210-00383
PMCID: PMC3805663  PMID: 22250077
23.  Provider-Initiated HIV Testing in Health Care Settings: Should it Include Client-Centered Counseling? 
To increase access to HIV-testing the WHO and CDC have recommended implementing provider-initiated HIV-testing (PITC). To address the resource limitations of the PITC setting WHO and CDC suggest that patient-provider interactions during PITC may need to focus on providing information and referrals instead of engaging patients in client-centered counseling as is recommended during client-initiated HIV-testing. Providing HIV-prevention information has been shown to be less effective than client-centered counseling at reducing HIV-risk behavior and STI incidence. Therefore, concerns exist about the efficacy of PITC as an HIV-prevention approach. However, reductions in HIV incidence may be larger if more people know their HIV-status through expanded availability of PITC, even if PITC is less effective than is client-initiated HIV-testing for individual patients. In the absence of an answer to this public health question, adaptation of effective brief client-centered counseling approaches to PITC should be explored along with research assessing the efficacy of PITC.
PMCID: PMC3800141  PMID: 20485851
provider-initiated HIV-testing; client-centered counseling; HIV prevention; developing countries
24.  What Primary Care Providers Need to Know about Pre-Exposure Prophylaxis (PrEP) for HIV Prevention: Narrative Review 
Annals of internal medicine  2012;157(7):490-497.
As HIV prevalence climbs globally, including more than 50,000 new infections per year in the United States, we need effective HIV prevention strategies. The use of antiretrovirals for pre-exposure prophylaxis (known as “PrEP”) among high-risk HIV-uninfected persons is emerging as one such strategy. Randomized controlled trials have demonstrated that once daily oral PrEP decreased HIV incidence among at-risk MSM and African heterosexuals, including HIV serodiscordant couples. An additional randomized control trial of a pericoital topical application of antiretroviral microbicide gel reduced HIV incidence among at-risk heterosexual South African women. Two other studies in African women did not demonstrate the efficacy of oral or topical PrEP, raising concerns about adherence patterns and efficacy in this population. The FDA Antiretroviral Advisory Panel reviewed these studies and additional data in May 2012 and recommended the approval of oral tenofovir-emtricitabine for PrEP in high-risk populations. Patients may seek PrEP from their primary care providers and those on PrEP require monitoring. Thus, primary care providers should become familiar with PrEP. This review outlines the current state of knowledge about PrEP as it pertains to primary care including identification of individuals likely to benefit from PrEP, counseling to maximize adherence and minimize potential increases in risky behavior, and monitoring for potential drug toxicities, HIV acquisition, and antiretroviral drug resistance. Issues related to cost and insurance coverage are also discussed. Recent data suggest that PrEP, in conjunction with other prevention strategies, holds promise in helping to curtail the HIV epidemic.
doi:10.7326/0003-4819-157-7-201210020-00510
PMCID: PMC3790586  PMID: 22821365
25.  Social Network and Risk-Taking Behavior Most Associated with Rapid HIV Testing, Circumcision, and Preexposure Prophylaxis Acceptability Among High-Risk Indian Men 
AIDS Patient Care and STDs  2012;26(10):631-640.
Abstract
Indian truck drivers and their younger apprentice drivers are at increased risk of HIV infection. We determine network and risk practices associated with willingness to adopt HIV prevention interventions currently not being used in India: rapid HIV testing, circumcision, and preexposure prophylaxis (PrEP) in order to inform the National AIDS Control Program (NACP). Truck drivers and truck cleaners were systematically recruited to participate in a social network and risk survey in Hyderabad, Southern India. Three separate composite measures of acceptability of rapid HIV testing, circumcision, and PrEP acceptability were utilized to independently assess the relationship of these prevention interventions with risk-practices and social network characteristics. An 89% participation rate yielded 1602 truck drivers and truck cleaners with 54.2% younger than 30 years of age and 2.8% HIV infected. Twenty-five percent of respondents reported sex with female sex workers (FSW) and 5% with men (MSM). Rapid testing, circumcision, and PrEP acceptability were 97.4%, 9.1%, and 85.9%, respectively. Participants reporting prosocial network characteristics were more accepting of rapid testing (adjusted odds ratio [AORs] 3.07–6.71; p<0.05) and demonstrated variable PrEP acceptability (AORs 0.08–2.22; p<0.001). Sex with FSWs was associated with PrEP acceptability (AOR 4.27; p<0.001); sex with MSM was associated with circumcision acceptability only (AOR 2.66; p<0.01). Social network factors and risk-practices were associated with novel prevention acceptability, but not consistently across intervention type and with variable directionality. The NACP will need to consider that intervention uptake may likely be most successful when efforts are targeted to individuals with specific behavior and social network characteristics.
doi:10.1089/apc.2012.0188
PMCID: PMC3462390  PMID: 22973951

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