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1.  What’s God got to do with it? Engaging African American faith-based institutions in HIV prevention 
Global public health  2013;8(3):258-269.
African Americans are disproportionately infected and affected by HIV/AIDS. Although faith-based institutions play critical leadership roles in the African American community, the faith-based response to HIV/AIDS has historically been lacking. We explore recent successful strategies of a citywide HIV/AIDS awareness and testing campaign developed in partnership with 40 African American faith-based institutions in Philadelphia, Pennsylvania, a city with some of the United State’s highest HIV infection rates. Drawing on important lessons from the campaign and subsequent efforts to sustain the campaign’s momentum with a citywide HIV testing, treatment and awareness program, we provide a roadmap for engaging African American faith communities in HIV prevention that include partnering with faith leaders; engaging the media to raise awareness, destigmatising HIV/AIDS and encouraging HIV testing; and conducting educational and HIV testing events at houses of worship. African American faith based institutions have a critical role to play in raising awareness about the HIV/AIDS epidemic and for reducing racial disparities in HIV infection.
doi:10.1080/17441692.2012.759608
PMCID: PMC3601577  PMID: 23379422
African Americans; HIV/AIDS; health disparities; faith community; clergy; pastors
2.  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
3.  Outcomes among HIV-1 Infected Individuals First Starting Antiretroviral Therapy with Concurrent Active TB or Other AIDS-Defining Disease 
PLoS ONE  2013;8(12):e83643.
Background
Tuberculosis (TB) is common among HIV-infected individuals in many resource-limited countries and has been associated with poor survival. We evaluated morbidity and mortality among individuals first starting antiretroviral therapy (ART) with concurrent active TB or other AIDS-defining disease using data from the “Prospective Evaluation of Antiretrovirals in Resource-Limited Settings” (PEARLS) study.
Methods
Participants were categorized retrospectively into three groups according to presence of active confirmed or presumptive disease at ART initiation: those with pulmonary and/or extrapulmonary TB (“TB” group), those with other non-TB AIDS-defining disease (“other disease”), or those without concurrent TB or other AIDS-defining disease (“no disease”). Primary outcome was time to the first of virologic failure, HIV disease progression or death. Since the groups differed in characteristics, proportional hazard models were used to compare the hazard of the primary outcome among study groups, adjusting for age, sex, country, screening CD4 count, baseline viral load and ART regimen.
Results
31 of 102 participants (30%) in the “TB” group, 11 of 56 (20%) in the “other disease” group, and 287 of 1413 (20%) in the “no disease” group experienced a primary outcome event (p = 0.042). This difference reflected higher mortality in the TB group: 15 (15%), 0 (0%) and 41 (3%) participants died, respectively (p<0.001). The adjusted hazard ratio comparing the “TB” and “no disease” groups was 1.39 (95% confidence interval: 0.93–2.10; p = 0.11) for the primary outcome and 3.41 (1.72–6.75; p<0.001) for death.
Conclusions
Active TB at ART initiation was associated with increased risk of mortality in HIV-1 infected patients.
doi:10.1371/journal.pone.0083643
PMCID: PMC3877069  PMID: 24391801
4.  Contribution of Substance Use Disorders on HIV Treatment Outcomes and Antiretroviral Medication Adherence Among HIV-infected Persons Entering Jail 
AIDS and behavior  2013;17(0 2):10.1007/s10461-013-0506-0.
doi:10.1007/s10461-013-0506-0
PMCID: PMC3818019  PMID: 23673792
Substance abuse; Jail; Prisoners; Engagement in HIV care; Antiretroviral therapy; Adherence; Criminal Justice; Prisoners
5.  HIV among persons incarcerated in the US: a review of evolving concepts in testing, treatment and linkage to community care 
Purpose of review
People who are incarcerated have a disproportionately high risk of HIV infection. They also tend to have risk factors associated with under-utilization of antiretroviral therapy such as substance abuse, mental illness, and poor access to care. In this review, we describe how incarceration is a marker of vulnerability for suboptimal HIV care, but also how criminal justice settings may be leveraged as a platform for promoting testing, linkage and retention in HIV care for a high-risk, marginalized population.
Recent findings
In both prisons and jails, routine, opt-out HIV testing strategies are more appropriate for screening correctional populations than traditional, risk-based strategies. Rapid HIV testing is feasible and acceptable in busy, urban jail settings. While antiretroviral therapy is successfully administered in many prison settings, release to the community is strongly associated with inconsistent access to medications and other structural factors leading to loss of viral suppression.
Summary
Collaborations among HIV clinicians, criminal justice personnel and public health practitioners represent an important strategy for turning the tide on the HIV epidemic. Success will depend upon scaled-up efforts to seek individuals with undiagnosed infection and bring those who are out-of-care into long-term treatment.
doi:10.1097/QCO.0b013e32835c1dd0
PMCID: PMC3682655  PMID: 23221766
HIV/AIDS; criminal justice system; jail; prison; HIV testing; transitional case management; substance abuse
6.  Clinical Impact and Cost-Effectiveness of Expanded Voluntary HIV Testing in India 
PLoS ONE  2013;8(5):e64604.
Background
Despite expanding access to antiretroviral therapy (ART), most of the estimated 2.3 to 2.5 million HIV-infected individuals in India remain undiagnosed. The questions of whom to test for HIV and at what frequency remain unclear.
Methods
We used a simulation model of HIV testing and treatment to examine alternative HIV screening strategies: 1) current practice, 2) one-time, 3) every five years, and 4) annually; and we applied these strategies to three population scenarios: 1) the general Indian population (“national population”), i.e. base case (HIV prevalence 0.29%; incidence 0.032/100 person-years [PY]); 2) high-prevalence districts (HIV prevalence 0.8%; incidence 0.088/100 PY), and 3) high-risk groups (HIV prevalence 5.0%; incidence 0.552/100 PY). Cohort characteristics reflected Indians reporting for HIV testing, with a median age of 35 years, 66% men, and a mean CD4 count of 305 cells/µl. The cost of a rapid HIV test was $3.33. Outcomes included life expectancy, HIV-related direct medical costs, incremental cost-effectiveness ratios (ICERs), and secondary transmission benefits. The threshold for “cost-effective” was defined as 3x the annual per capita GDP of India ($3,900/year of life saved [YLS]), or for “very cost-effective” was <1x the annual per capita GDP ($1,300/YLS).
Results
Compared to current practice, one-time screening was very cost-effective in the national population (ICER: $1,100/YLS), high-prevalence districts (ICER: $800/YLS), and high-risk groups (ICER: $800/YLS). Screening every five years in the national population (ICER: $1,900/YLS) and annual screening in high-prevalence districts (ICER: $1,900/YLS) and high-risk groups (ICER: $1,800/YLS) were also cost-effective. Results were most sensitive to costs of care and linkage-to-care.
Conclusions
In India, voluntary HIV screening of the national population every five years offers substantial clinical benefit and is cost-effective. Annual screening is cost-effective among high-risk groups and in high-prevalence districts nationally. Routine HIV screening in India should be implemented.
doi:10.1371/journal.pone.0064604
PMCID: PMC3669338  PMID: 23741348
7.  HIV testing practices among New England college health centers 
Background
The prevalence of human immunodeficiency virus (HIV) continues to increase among certain populations including young men who have sex with men (MSM). College campuses represent a potential setting to engage young adults and institute prevention interventions including HIV testing. The purpose of this study was to evaluate testing practices for HIV and other sexually transmitted infections (STIs) on college campuses.
Methods
Medical directors at four-year residential baccalaureate college health centers in New England were surveyed from June, 2011 to September, 2011. Thirty-one interviews were completed regarding experiences with HIV testing, acute HIV infection, other STI testing, and outreach efforts targeting specific at-risk groups such as MSM.
Results
Among schools that responded to the survey, less than five percent of students were tested for HIV at their local college health center in the past academic year (2010–2011). Significant barriers to HIV testing included cost and availability of rapid antibody testing. One-third of college health medical directors reported that their practitioners may not feel comfortable recognizing acute HIV infection.
Conclusions
Improved HIV testing practices are needed on college campuses. Programs should focus on outreach efforts targeting MSM and other at-risk populations.
doi:10.1186/1742-6405-10-8
PMCID: PMC3606211  PMID: 23496891
HIV; College; STI; Prevention
8.  Quality of Life Among Individuals with HIV Starting Antiretroviral Therapy in Diverse Resource-Limited Areas of the World 
AIDS and Behavior  2012;16(2):266-277.
As Antiretroviral Therapy (ART) is scaled up in low- and middle-income countries, it is important to understand Quality of Life (QOL) correlates including disease severity and person characteristics and to determine the extent of between-country differences among those with HIV. QOL and medical data were collected from 1,563 of the 1,571 participants at entry into a randomized clinical trial of ART conducted in the U.S. (n = 203) and 8 resource-limited countries (n = 1,360) in the Caribbean, South America, Asia, and Africa. Participants were interviewed prior to initiation of ART using a modified version of the ACTG SF-21, a health-related QOL measure including 8 subscales: general health perception, physical functioning, role functioning, social functioning, cognitive functioning, pain, mental health, and energy/fatigue. Other measures included demographics, CD4+ lymphocyte count, plasma HIV-1 RNA viral load. Higher quality of life in each of the 8 QOL subscales was associated with higher CD4+ lymphocyte category. General health perception, physical functioning, role functioning, and energy/fatigue varied by plasma HIV-1 RNA viral load categories. Each QOL subscale included significant variation by country. Only the social functioning subscale varied by sex, with men having greater impairments than women, and only the physical functioning subscale varied by age category. This was the first large-scale international ART trial to conduct a standardized assessment of QOL in diverse international settings, thus demonstrating that implementation of the behavioral assessment was feasible. QOL indicators at study entry varied with disease severity, demographics, and country. The relationship of these measures to treatment outcomes can and should be examined in clinical trials of ART in resource-limited settings using similar methodologies.
doi:10.1007/s10461-011-9947-5
PMCID: PMC3182285  PMID: 21499794
Quality of life (QOL); Highly active antiretroviral therapy (HAART); HIV
9.  Recent Clinical History and Cognitive Dysfunction for Attention and Executive Function among Human Immunodeficiency Virus-Infected Patients 
This study examined the association between recent trends in CD4 and viral loads and cognitive test performance with the expectation that recent history could predict cognitive performance. Eighty-three human immunodeficiency virus (HIV)-infected patients with a mean CD4 count of 428 copies/ml were examined in this study (62% with undetectable plasma viral load [PVL]). We investigated the relationships between nadir CD4 cell count, 1-year trends in immunologic function/PVLs, and cognitive performance across several domains using linear regression models. Nadir CD4 cell count was predictive of current executive function (p = .004). One year clinical history for CD4 cell counts and/or PVLs were predictive of executive function, attention/working memory, and learning/memory measures (p < .05). Models that combined recent clinical history trends and nadir CD4 cell counts suggested that recent clinical trends were more important in predicting current cognitive performance for all domains except executive function. This research suggests that recent CD4 and viral load history is an important predictor of current cognitive function across several cognitive domains. If validated, clinical variables and cognitive dysfunction models may improve our understanding of the dynamic relationships between disease evolution and progression and CNS involvement.
doi:10.1093/arclin/acr065
PMCID: PMC3243921  PMID: 21873325
HIV; Cognition; Neuropsychology; Executive function; Recent clinical history
10.  Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings 
PLoS Medicine  2012;9(8):e1001290.
Thomas Campbell and colleagues report findings of a randomized trial conducted in multiple countries regarding the efficacy of antiretroviral regimens with simplified dosing.
Background
Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.
Methods and Findings
1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure.
An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72–1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54–0.76; p<0.001) and there was a significant interaction between sex and regimen safety (HR 0.50, CI 0.39–0.64 for women; HR 0.79, CI 0.62–1.00 for men; p = 0.01). Comparing ATV+DDI+FTC to EFV+3TC-ZDV, during a median follow-up of 81 wk there were 108 failures (21%) among 526 participants assigned to ATV+DDI+FTC and 76 (15%) among 519 participants assigned to EFV+3TC-ZDV (HR 1.51, CI 1.12–2.04; p = 0.007).
Conclusion
EFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen.
Trial Registration
www.ClinicalTrials.gov NCT00084136
Please see later in the article for the Editors' Summary.
Editors' Summary
Background
Despite the enormous gains in reducing HIV-related illness and death over the past decade, there are still considerable challenges to meeting the global goal of universal access to highly active antiretroviral treatment—a combination of effective drugs that attack the HIV virus in various ways—to everyone living with HIV/AIDS who could benefit from treatment. In recognition of the related financial, technical, and system obstacles to providing universal access to HIV treatment, in 2010 the UN agency responsible for HIV/AIDS—UNAIDS—launched an ambitious plan called Treatment 2.0, which aims to simplify the way HIV treatment is currently provided. One of the main focuses of Treatment 2.0 is to simplify drug regimes for the treatment of HIV and to make treatment regimes less toxic. In line with Treatment 2.0, the World Health Organization currently recommends that antiretroviral regimens for the initial treatment of HIV should include two nucleoside reverse transcriptase inhibitors (zidovudine or tenofovir disoproxil fumarate [DF] with lamivudine or emtricitabine) and a non-nucleoside reverse transcriptase inhibitor (efavirenz or nevirapine.)
Why Was This Study Done?
Most of the evidence about the safety and effectiveness of clinical trials come from clinical trials in high-income countries and thus is not generally representative of the majority of people with HIV. So in this study, the researchers conducted a randomized controlled trial in diverse populations in many different settings to investigate whether antiretroviral regimens administered once daily were as effective as twice-daily regimens and also whether a regimen containing the drug atazanavir administered once daily was as safe and effective as a regimen containing efavirenz—data from previous studies have suggested that atazanavir has characteristics, such as its side effect profile, which may make it more suitable for low income settings.
What Did the Researchers Do and Find?
The researchers recruited eligible patients from centers in Brazil, Haiti, India, Malawi, Peru, South Africa, Thailand, the United States, and Zimbabwe—almost half (47%) were women. Then the researchers randomly assigned participants to one of three regimens: efavirenz 600 mg daily plus co-formulated lamivudine-zidovudine 150 mg/300 mg twice daily (EFV+3TC-ZDV); or atazanavir 400 mg once daily, plus didanosine-EC 400 mg once daily, plus emtricitabine 200 mg once daily (ATV+DDI+FTC); or efavirenz 600 mg once daily plus coformulated emtricitabine-tenofovir-DF 200 mg/300 mg once daily (EFV+FTC-TDF). During the study period ATV+DDI+FTC was found to be inferior to EFV+3TC-ZDV, so the Multinational Data Safety Monitoring Board ordered this arm of the trial to stop. Then a year later, due to the low number of treatment failures (deaths, severe HIV disease, or serious opportunistic infections) in the remaining two arms, the board advised the trial to stop early. So the researchers analyzed the data obtained up to this point and pooled the results from all of the centers.
The researchers found that during an average of 184 weeks of follow-up, there were 95 treatment failures (18%) among 526 participants taking EFV+FTC-TDF compared to 98 failures among 519 participants taking EFV+3TC-ZDV. During an average 81 weeks follow-up, there were 108 failures (21%) among 526 participants assigned to ATV+DDI+FTC and 76 (15%) among 519 participants assigned to EFV+3TC-ZDV. As for safety, 243 (46%) participants assigned to EFV+FTC-TDF reached a safety endpoint (grade 3 disease, abnormal lab measurement, or the need to change drug) compared to 313 (60%) in the EFV+3TC-ZDV group. Importantly, the researchers found that there was greater risk of safety events for women assigned to EFV+3TC-ZDV and also that the atazanavir-based regimen had a higher relative efficacy in women compared to men.
What Do These Findings Mean?
These findings suggest that in diverse populations, EFV+FTC-TDF is as effective as EFV+3TC-ZDV but importantly, the once-daily dosing of EFV+FTC-TDF makes this regimen useful for the initial treatment of HIV, especially in low-income countries. Therefore, as per the guidance in Treatment 2.0, EFV+FTC-TDF in a single combination tablet that can be taken once a day is an attractive option. These findings also indicate that as ATV+DDI+FTC was found to be inferior to the other regimens, this combination should not be used in the initial treatment of HIV. These findings also add to the evidence that antiretroviral efficacy and safety can differ between women and men and support further development of sex-specific recommendations for antiretroviral regimen options.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001290.
The UNAIDS website has more information about Treatment 2.0; and the WHO website provides technical information
For an introduction to the treatment of HIV/AIDS see http://www.avert.org/treatment.htm; the AVERT site also has personal stories from women living with HIV/AIDS
AIDSmap provides information for individuals and communities affected by HIV/AIDS
The ACTG website provides information about research to improve treatment of HIV and related complications
doi:10.1371/journal.pmed.1001290
PMCID: PMC3419182  PMID: 22936892
11.  Keeping the Faith: African American Faith Leaders’ Perspectives and Recommendations for Reducing Racial Disparities in HIV/AIDS Infection 
PLoS ONE  2012;7(5):e36172.
In Philadelphia, 66% of new HIV infections are among African Americans and 2% of African Americans are living with HIV. The city of Philadelphia has among the largest numbers of faith institutions of any city in the country. Although faith-based institutions play an important role in the African American community, their response to the AIDS epidemic has historically been lacking. We convened 38 of Philadelphia’s most influential African American faith leaders for in-depth interviews and focus groups examining the role of faith-based institutions in HIV prevention. Participants were asked to comment on barriers to engaging faith-based leaders in HIV prevention and were asked to provide normative recommendations for how African American faith institutions can enhance HIV/AIDS prevention and reduce racial disparities in HIV infection. Many faith leaders cited lack of knowledge about Philadelphia’s racial disparities in HIV infection as a common reason for not previously engaging in HIV programs; others noted their congregations’ existing HIV prevention and outreach programs and shared lessons learned. Barriers to engaging the faith community in HIV prevention included: concerns about tacitly endorsing extramarital sex by promoting condom use, lack of educational information appropriate for a faith-based audience, and fear of losing congregants and revenue as a result of discussing human sexuality and HIV/AIDS from the pulpit. However, many leaders expressed a moral imperative to respond to the AIDS epidemic, and believed clergy should play a greater role in HIV prevention. Many participants noted that controversy surrounding homosexuality has historically divided the faith community and prohibited an appropriate response to the epidemic; many expressed interest in balancing traditional theology with practical public health approaches to HIV prevention. Leaders suggested the faith community should: promote HIV testing, including during or after worship services and in clinical settings; integrate HIV/AIDS topics into health messaging and sermons; couch HIV/AIDS in social justice, human rights and public health language rather than in sexual risk behavior terms; embrace diverse approaches to HIV prevention in their houses of worship; conduct community outreach and host educational sessions for youth; and collaborate on a citywide, interfaith HIV testing and prevention campaign to combat stigma and raise awareness about the African American epidemic. Many African American faith-based leaders are poised to address racial disparities in HIV infection. HIV prevention campaigns should integrate leaders’ recommendations for tailoring HIV prevention for a faith-based audience.
doi:10.1371/journal.pone.0036172
PMCID: PMC3353968  PMID: 22615756
12.  Safety, Tolerability, and efficacy of second-line generic protease inhibitor containing HAART after first-line failure among South Indian HIV-infected patients 
Introduction
We describe the safety, tolerability, and efficacy of protease inhibitor (PI) containing HAART among patients switching from non-nucleoside reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART) from a clinical setting in South India.
Methods
We assessed a prospective cohort of 91 HIV-infected patients with at least 12 months of clinical follow-up on second line ritonvair boosted PI-based therapy between August 2003 and December 2008.
Results
Over three-fourths of patients met the WHO criteria for immunological failure at the time of switch. The median time to switch was 758 days. Patients demonstrated consistent increases in their CD4 cell counts during the first 12 months, by which time the median CD4 cell count was 322 cells/ul. The most common adverse events within the first year after switch were nausea (14.8%), lipodystrophy (10.4%), and peripheral neuropathy (7.0%). Patients switching to ATV-based regimens compared to those switching to IDV-based regimens had similar immunological and clinical outcomes.
Conclusions
Given the therapeutic success of utilizing second-line PI-containing HAART after experiencing treatment failure, further efforts must be taken to expand access to second-line HAART so that more patients can benefit from these drugs.
doi:10.1177/1545109710382780
PMCID: PMC3128549  PMID: 21266320
HIV; AIDS; India; HAART; second-line therapy; protease inhibitors
13.  Viral Decay Rates are Similar in HIV-infected Patients with and without TB Coinfection during Treatment with an Efavirenz-based Regimen 
Viral decay rates during efavirenz-based therapy were compared between HIV-infected patients without (N=40) and with tuberculosis coinfection on concurrent antituberculous therapy (N=34). Phase 1 and II viral decay rates were similar in the two groups (P>0.05). Overall, concurrent antituberculous therapy did not reduce the efficacy of the HIV treatment.
Viral decay rates during efavirenz-based therapy were compared between human immunodeficiency virus (HIV)–infected patients without tuberculosis (n = 40) and those with tuberculosis coinfection who were receiving concurrent antituberculous therapy (n = 34). Phase I and II viral decay rates were similar in the 2 groups (P > .05). Overall, concurrent antituberculous therapy did not reduce the efficacy of the HIV treatment.
doi:10.1093/cid/ciq196
PMCID: PMC3060905  PMID: 21252140
14.  HIV Treatment Outcomes Among HIV-Infected, Opioid-Dependent Patients Receiving Buprenorphine/Naloxone Treatment within HIV Clinical Care Settings: Results From a Multisite Study 
Background
Having opioid dependence and HIV infection are associated with poor HIV-related treatment outcomes.
Methods
HIV-infected, opioid-dependent subjects (N = 295) recruited from 10 clinical sites initiated buprenorphine/naloxone (BUP/NX) and were assessed at baseline and quarterly for 12 months. Primary outcomes included receiving antiretroviral therapy (ART), HIV-1 RNA suppression, and mean changes in CD4 lymphocyte count. Analyses were stratified for the 119 subjects not on ART at baseline. Generalized estimating equations were deployed to examine time-dependent correlates for each outcome.
Results
At baseline, subjects on ART (N = 176) were more likely than those not on ART (N = 119) to be older, heterosexual, have lower alcohol addiction severity scores, and lower HIV-1 RNA levels; they were less likely to be homeless and report sexual risk behaviors. Subjects initiating BUP/NX (N = 295) were significantly more likely to initiate or remain on ART and improve CD4 counts over time compared with baseline; however, these improvements were not significantly improved by longer retention on BUP/NX. Retention on BUP/NX for three or more quarters was, however, significantly associated with increased likelihood of initiating ART (β = 1.34 [1.18, 1.53]) and achieve viral suppression (β = 1.25 [1.10, 1.42]) for the 64 of 119 (54%) subjects not on ART at baseline compared with the 55 subjects not retained on BUP/NX. In longitudinal analyses, being on ART was positively associated with increasing time of observation from baseline and higher mental health quality of life scores (β = 1.25 [1.06, 1.46]) and negatively associated with being homo- or bisexual (β = 0.55 [0.35, 0.97]), homeless (β = 0.58 [0.34, 0.98]), and increasing levels of alcohol addiction severity (β = 0.17 [0.03, 0.88]). The strongest correlate of achieving viral suppression was being on ART (β = 10.27 [5.79, 18.23]). Female gender (β = 1.91 [1.07, 3.41]), Hispanic ethnicity (β = 2.82 [1.44, 5.49]), and increased general health quality of life (β = 1.02 [1.00,1.04]) were also independently correlated with viral suppression. Improvements in CD4 lymphocyte count were significantly associated with being on ART and increased over time.
Conclusions
Initiating BUP/NX in HIV clinical care settings is feasible and correlated with initiation of ART and improved CD4 lymphocyte counts. Longer retention on BPN/NX was not associated with improved prescription of ART, viral suppression, or CD4 lymphocyte counts for the overall sample in which the majority was already prescribed ART at baseline. Among those retained on BUP/NX, HIV treatment outcomes did not worsen and were sustained. Increasing time on BUP/NX, however, was especially important for improving HIV treatment outcomes for those not on ART at baseline, the group at highest risk for clinical deterioration. Retaining subjects on BUP/NX is an important goal for sustaining HIV treatment outcomes for those on ART and improving them for those who are not. Comorbid substance use disorders (especially alcohol), mental health problems, and quality–of-life indicators independently contributed to HIV treatment outcomes among HIV-infected persons with opioid dependence, suggesting the need for multidisciplinary treatment strategies for this population.
doi:10.1097/QAI.0b013e318209751e
PMCID: PMC3263431  PMID: 21317590
HIV; acquired immunodeficiency syndrome; buprenorphine; antiretroviral therapy; CD4; HIV-1 RNA; longitudinal cohort; substance use disorders; opioid dependence; healthcare integration; addiction severity; quality of life; alcohol dependence
16.  Motivation and Patch Treatment for HIV+ Smokers: A Randomized Controlled Trial 
Addiction (Abingdon, England)  2009;104(11):1891-1900.
Aims
To test the efficacy of two smoking cessation interventions in an HIV+ sample: standard care (SC) treatment plus nicotine replacement therapy (NRT) versus more intensive motivationally-enhanced (ME) treatment plus NRT.
Design
randomized controlled trial.
Setting
HIV+ smoker referrals from eight Immunology clinics in the Northeastern US.
Participants
444 participants enrolled in the study (mean age=42 years; 63% male; 52% European-American; mean cigarettes/day=22.8).
Interventions
SC received two brief sessions with a Health Educator. Those setting a quit date received self-help quitting materials and NRT. ME received four sessions of motivational counseling and a quit-day counseling call. All ME intervention materials were tailored to the needs of HIV+ individuals.
Measurements
Biochemically-verified 7-day abstinence rates at 2-month, 4-month, and 6-month follow-ups.
Findings
Intent-to-Treat (ITT) abstinence rates at 2-month, 4-month, and 6-month follow-ups were 12%, 9%, and 9% respectively in the ME condition, and 13%, 10%, and 10% respectively in the SC condition, indicating no between-group differences. Among 412 participants with treatment utilization data, 6-month ITT abstinence rates were positively associated with low nicotine dependence (p=0.02), high motivation to quit (p=0.04), and Hispanic-American race/ethnicity (p=0.02). Adjusting for these variables, each additional NRT contact improved the odds of smoking abstinence by a third (OR=1.32, 95% CI= 0.99–1.75).
Conclusions
Motivationally-enhanced treatment plus NRT did not improve cessation rates over and above standard care treatment plus NRT in this HIV+ sample of smokers. Providers offering brief support and encouraging use of nicotine replacement may be able to help HIV+ patients quit smoking.
doi:10.1111/j.1360-0443.2009.02623.x
PMCID: PMC2763031  PMID: 19719796
HIV; tobacco cessation; nicotine replacement; Transtheoretical Model
17.  Cost-Effectiveness of HIV Testing Referral Strategies among Tuberculosis Patients in India 
PLoS ONE  2010;5(9):e12747.
Background
Indian guidelines recommend routine referral for HIV testing of all tuberculosis (TB) patients in the nine states with the highest HIV prevalence, and selective referral for testing elsewhere. We assessed the clinical impact and cost-effectiveness of alternative HIV testing referral strategies among TB patients in India.
Methods and Findings
We utilized a computer model of HIV and TB disease to project outcomes for patients with active TB in India. We compared life expectancy, cost, and cost-effectiveness for three HIV testing referral strategies: 1) selective referral for HIV testing of those with increased HIV risk, 2) routine referral of patients in the nine highest HIV prevalence states with selective referral elsewhere (current standard), and 3) routine referral of all patients for HIV testing. TB-related data were from the World Health Organization. HIV prevalence among TB patients was 9.0% in the highest prevalence states, 2.9% in the other states, and 4.9% overall. The selective referral strategy, beginning from age 33.50 years, had a projected discounted life expectancy of 16.88 years and a mean lifetime HIV/TB treatment cost of US$100. The current standard increased mean life expectancy to 16.90 years with additional per-person cost of US$10; the incremental cost-effectiveness ratio was US$650/year of life saved (YLS) compared to selective referral. Routine referral of all patients for HIV testing increased life expectancy to 16.91 years, with an incremental cost-effectiveness ratio of US$730/YLS compared to the current standard. For HIV-infected patients cured of TB, receiving antiretroviral therapy increased survival from 4.71 to 13.87 years. Results were most sensitive to the HIV prevalence and the cost of second-line antiretroviral therapy.
Conclusions
Referral of all patients with active TB in India for HIV testing will be both effective and cost-effective. While effective implementation of this strategy would require investment, routine, voluntary HIV testing of TB patients in India should be recommended.
doi:10.1371/journal.pone.0012747
PMCID: PMC2940842  PMID: 20862279
18.  Lessons learned from family-centred models of treatment for children living with HIV: current approaches and future directions 
Background
Despite strong global interest in family-centred HIV care models, no reviews exist that detail the current approaches to family-centred care and their impact on the health of children with HIV. A systematic review of family-centred HIV care programmes was conducted in order to describe both programme components and paediatric cohort characteristics.
Methods
We searched online databases, including PubMed and the International AIDS Society abstract database, using systematic criteria. Data were extracted regarding programme setting, staffing, services available and enrolment methods, as well as cohort demographics and paediatric outcomes.
Results
The search yielded 25 publications and abstracts describing 22 separate cohorts. These contained between 43 and 657 children, and varied widely in terms of staffing, services provided, enrolment methods and cohort demographics. Data on clinical outcomes was limited, but generally positive. Excellent adherence, retention in care, and low mortality and/or loss to follow up were documented.
Conclusions
The family-centred model of care addresses many needs of infected patients and other household members. Major reported obstacles involved recruiting one or more types of family members into care, early diagnosis and treatment of infected children, preventing mortality during children's first six months of highly active antiretroviral therapy, and staffing and infrastructural limitations. Recommendations include: developing interventions to enrol hard-to-reach populations; identifying high-risk patients at treatment initiation and providing specialized care; and designing and implementing evidence-based care packages. Increased research on family-centred care, and better documentation of interventions and outcomes is also critical.
doi:10.1186/1758-2652-13-S2-S3
PMCID: PMC2890972  PMID: 20573285
20.  Heavy injection drug use is associated with lower percent body fat in a multi-ethnic cohort of HIV-positive and HIV-negative drug users from three U.S. cities 
Background
The clinical implications of lower body weight in drug using populations are uncertain given that lower mean weights may still fall within the healthy range.
Objectives
To determine the effect of type, mode and frequency of drug use on underlying body composition after accounting for differences in body shape and size.
Methods
We conducted a cross-sectional analysis of 511 participants from the Tufts Nutrition Collaborative (TNC) Study. Data included measures of body composition, a 24-hour dietary recall, and a detailed health history and lifestyle questionnaire. Multivariate regression analysis was used to determine the independent effect of drug use on percent body fat (BF) after adjusting for BMI and waist circumference.
Results
Heavy injection drug users (IDUs) had a 2.6% lower percent BF than non-users after adjusting for BMI, waist circumference, and other confounders. (p=0.0006). Differences in percent BF were predominantly due to higher lean mass, rather than lower fat mass. Cocaine and heroin had similar effects on body composition.
Conclusions
In the U.S., where the general population is prone to over-nutrition, the average percent BF for heavy injectors does not fall into a range low enough to suggest harmful effects. However, in populations with substantial levels of under-nutrition, small differences in percent BF among drug users will have a greater impact on health status.
Scientific Significance
Differences in BMI, weight and body composition are not always straightforward. Accounting for underlying nutritional status and relative differences in fat and FFM is critical when interpreting results.
doi:10.3109/00952990903544851
PMCID: PMC2837874  PMID: 20141402
21.  Modified Directly Observed Antiretroviral Therapy Compared with Self-Administered Therapy in Treatment-Naïve HIV-1 Infected Patients: A Randomized Trial 
Archives of internal medicine  2009;169(13):1224-1232.
Context
Success of antiretroviral therapy depends on high rates of adherence, but few interventions are effective.
Objective
Determine if modified directly observed therapy (mDOT) improves initial antiretroviral success.
Design
Open-label randomized trial comparing mDOT and self-administered therapy with lopinavir/ritonavir soft gel capsules 800 mg/200 mg, emtricitabine 200 mg, and either extended release stavudine 100 mg or tenofovir 300 mg, all once daily.
Setting
23 U.S. AIDS Clinical Trials Group (ACTG) sites and one in South Africa between October 2002 and January 2006.
Participants
Plasma HIV RNA ≥2000 copies/ml and antiretroviral-naïve. 82 participants received mDOT and 161 self-administration. Participants were predominantly male (79%), median age 38 years, with 84 Latinos (35%), 74 non-Latino blacks (30%), and 79 non-Latino whites (33%).
Intervention
mDOT Monday through Friday for 24 weeks.
Main Outcome Measure(s)
Primary outcome was week 24 virologic success and secondary outcomes were week 48 virologic success, clinical progression, and adherence.
Results
mDOT had greater virologic success over 24 weeks [0.91 (95% CI: 0.81, 0.95)] than self-administered therapy [0.84 (95% CI: 0.77, 0.89)], but the difference [0.07 (lower bound 95% CI: −0.01)] did not reach the pre-specified threshold of 0.075. Over 48 weeks, virologic success was not significantly different between mDOT [0.72 (95% CI: 0.61, 0.81)] and self-administered therapy [0.78 (95% CI: 0.70, 0.84)], [−0.06 (95% CI: −0.18, 0.07); p=0.19)].
Conclusions
The potential benefit of mDOT was marginal and not sustained after mDOT was discontinued. mDOT should not be incorporated routinely for care of treatment naïve HIV-1 infected patients.
doi:10.1001/archinternmed.2009.172
PMCID: PMC2771688  PMID: 19597072
HIV-1; antiretroviral therapy; adherence; randomized trial; directly observed therapy
22.  Acute mild footshock alters ethanol drinking and plasma corticosterone levels in C57BL/6J male mice, but not DBA/2J or A/J male mice 
Alcohol (Fayetteville, N.Y.)  2008;42(6):469-476.
Stress is an often-reported cause for alcohol consumption in humans. Acute intermittent footshock is a frequently used paradigm to produce stress in laboratory animals including mice. The effect produced by intermittent footshock stress on ethanol self-administration has been inconsistent: both increases and decreases in ethanol consumption have been reported. The current set of studies further investigates, in three commonly studied mouse strains, the effect of footshock stress on ethanol self-administration. Furthermore, the effect of footshock on plasma corticosterone levels was determined to investigate potential biochemical correlates. Adult male C57BL/6J, DBA/2J, and A/J mice were allowed to self-administer 10% (wt/vol) ethanol for 12 days in a standard 23-h two-bottle paradigm before receiving either 15 min of mild inescapable footshock or no footshock. Shock intensity was equal to the mean intensity at which each strain vocalized as previously determined. Following footshock, animals had the opportunity to self-administer ethanol for an additional 23 h. Separate animals were subjected to either footshock or no shock prior to collection of plasma for corticosterone. Mild footshock stress altered ethanol self-administration and increased plasma corticosterone levels in C57BL/6J mice. Footshock stress did not alter ethanol self-administration or plasma corticosterone levels in DBA/2J or A/J mice. These data demonstrate that mild footshock stress is a suboptimal method of modeling the stress-induced increases in ethanol consumption often reported by humans.
doi:10.1016/j.alcohol.2008.05.001
PMCID: PMC2575102  PMID: 18599253
Ethanol self-administration; Mice; Footshock stress; Corticosterone
23.  Apathy is Associated With Volume of the Nucleus Accumbens in Patients Infected With HIV 
Apathy refers to a reduction in self-initiated behavior, and it is commonly reported by patients infected with human immunodeficiency virus (HIV). It remains unclear whether apathy among HIV patients reflects a direct effect of the virus on subcortical brain circuits or a secondary neuropsychiatric symptom. In the present study we examined the relationship between ratings of apathy and quantitative analysis of the nucleus accumbens (NA), a subcortical brain structure that regulates initiation of behavioral activation. Twelve HIV-positive individuals without dementia were administered the Marin Apathy Scale and underwent neuroimaging. Voxel-based quantification of the nucleus accumbens was completed using a segmentation protocol. Results of our study revealed that increased ratings of apathy were significantly correlated with lower volume of the nucleus accumbens. By contrast, ratings of depression were unrelated to either apathy or nucleus accumbens volume. These findings provide preliminary evidence that apathy reflects direct involvement of the central nervous system in patients with HIV.
doi:10.1176/appi.neuropsych.17.2.167
PMCID: PMC2725432  PMID: 15939969
24.  HIV-2 diagnosis and quantification in high-risk patients 
Current diagnostic assays for HIV-1 do not always test for the presence of HIV-2 in the United States. We present the case of a patient from Cape Verde, who was admitted to our hospital with rapidly deteriorating neurological function and multiple white matter lesions on MRI likely secondary to progressive multifocal leukoencephalopathy (PML). Initially, the patient had a positive EIA for HIV, but a negative HIV-1 Western Blot and no viral load detected on a branched-DNA assay. A repeat viral load by reverse transcriptase methodology (RT-DNA) detected 121,000 copies and an HIV-2 Western Blot was positive. The case highlights an extremely rare presentation of HIV-2 with severe neurological disease. We discuss the different tests available for the diagnosis and monitoring of HIV-2 in the United States.
doi:10.1186/1742-6405-5-18
PMCID: PMC2529329  PMID: 18700986
25.  Clinical impact and cost-effectiveness of antiretroviral therapy in India: starting criteria and second-line therapy 
AIDS (London, England)  2007;21(Suppl 4):S117-S128.
Background
India has more than 5.7 million people infected with human immunodeficiency virus (HIV). In 2004, the Indian government began providing antiretroviral therapy (ART), and there are now an estimated 56 500 people receiving ART.
Objective
To project the life expectancy, cost, and cost-effectiveness associated with different strategies for using ART in India, to inform treatment programs.
Methods
We utilized an HIV disease simulation model, incorporating data on natural history, treatment efficacy, and costs of care from India. Input parameters for the simulated cohort included mean age 32.6 years and mean CD4 count 318 cells/μl (SD 291 cells/μl). We examined different criteria for starting and stopping ART with a first-line regimen of stavudine/lamivudine/nevirapine, and the impact of a second-line protease-inhibitor-based regimen. Cost-effectiveness in US dollars per year of life saved (US$/YLS) was compared incrementally among alternative starting, sequencing, and stopping criteria.
Results
Discounted (undiscounted) mean survival ranged from 34.5 (37.5) months with no ART to 64.7 (73.6) months with one line of therapy initiated at CD4 < 350 cells/μl, to 88.9 (106.5) months with two lines of therapy initiated at CD4 < 350 cells/μl. Lifetime medical costs ranged from US$530 (no ART) to US$5430 (two ART regimens) per person. With one line of therapy, the incremental cost-effectiveness ratios ranged from US$430/YLS to US$550/YLS as the CD4 starting criterion was increased from CD4 < 250 cells/μl to < 350 cells/μl. Use of two lines of therapy had an incremental cost-effectiveness ratio of US$1880/YLS compared with the use of first-line therapy alone. Results were sensitive to the costs of second-line therapy and criteria for stopping therapy.
Conclusions
In India, antiretroviral therapy will lead to major survival benefits and is cost-effective by World Health Organization criteria. The availability of second-line regimens will further increase survival, but their cost-effectiveness depends on their relative cost compared with first-line regimens.
doi:10.1097/01.aids.0000279714.60935.a2
PMCID: PMC2365748  PMID: 17620747
antiretroviral therapy; HIV/AIDS; India

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