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1.  Care at the Crossroads: Navigating the HIV, HCV, and Substance Abuse Syndemic 
For patients with both HIV/HCV coinfection and substance addiction, multidisciplinary teams can facilitate coordination of care and improve clinical outcomes. Such teams should include HIV/HCV treatment providers, mental health specialists, case managers, social workers, and substance abuse counselors.
PMCID: PMC4266471  PMID: 25520548
2.  Sex differences in perceived risk and testing experience of HIV in an urban fishing setting in Ghana 
Understanding sex differences in willingness to test and testing experience could aid the design of focus interventions to enhance uptake and engagement with care, treatment and support services. This study determined differences in perceived risk of acquiring HIV, willingness to test and HIV testing experience in an urban fishing community.
A cross-sectional community survey was conducted in 2013 among men and women in two fishing communities (Chorkor and James Town) in Accra. In all, 554 subjects (≥18 years) were involved, 264 in Chorkor and 290 in James Town. Data on demographic characteristics, perceived risk for HIV and willingness to test for HIV and testing experience were collected with a structured questionnaire. Descriptive statistics and Chi square test were used for the analysis at 95% significant level, using SPSS version 21.
Of 554 subjects, 329 (59.4%) were females, and median age was 32 years. Overall, only 91(40.4%) men and 118(35.9%) women perceived themselves to be at risk of acquiring HIV. A significant proportion of women were willing to test for HIV compared to men (86.3% vs. 80.0%, P = 0.048). Women were more likely to have ever tested for HIV compared to men (42.2% vs. 28.6%, P = 0.001) and more women had tested within 12 months prior to survey than men (49.6% vs. 40.6%, P = 0.230). Of the number who had tested for HIV infection, a higher proportion of men tested voluntarily 42(65.6%), while a higher proportion of women tested as part of healthcare service received 96(69.1%); (P = 0.001; indicating women vs. men).
Sex differences in risk perception and willingness to test need more focused public education and behaviour change communication strategies to achieve high coverage. Community-based strategies could improve HIV testing among men whilst more access to testing in health settings should be available to women in these communities.
PMCID: PMC4234896  PMID: 25398271
HIV testing; Sex differences; Perceived risks; Urban community; Ghana
3.  Buprenorphine for Human Immunodeficiency Virus/Hepatitis C Virus–coinfected Patients 
Journal of addiction medicine  2012;6(3):179-185.
Buprenorphine is associated with enhanced human immunodeficiency virus (HIV) treatment outcomes including increased antiretroviral therapy initiation rates, adherence, and CD4+ cell counts among HIV-infected opioid-dependent individuals. Buprenorphine facilitates hepatitis C virus (HCV) treatment in opioid-dependent patients with HCV monoinfection. Less is known about buprenorphine’s role in HIV/HCV coinfection.
We conducted a retrospective chart review to evaluate HCV care for HIV-infected buprenorphine patients in the first 4 years of buprenorphine’s integration into a Rhode Island HIV clinic.
Sixty-one patients initiated buprenorphine. All had HCV antibody testing; 57 (93%) were antibody-positive. All antibody-positive patients underwent HCV RNA testing; 48 (84%) were RNA-positive. Of these, 15 (31%) were not referred to HCV care. Among chronically infected patients, 3 received HCV treatment after buprenorphine; all had cirrhosis and none achieved viral eradication. At buprenorphine induction, most patients had inadequately controlled HIV infection, with detectable HIV RNA (59%) or CD4+ cell count less than or equal to 350/µL (38%).
Buprenorphine has shown limited success to date as a bridge to HCV treatment within an HIV clinic. Buprenorphine’s stabilization of opioid dependence and HIV disease may permit the use of HCV therapy over time.
PMCID: PMC4209296  PMID: 22614935
buprenorphine; hepatitis C virus (HCV); HIV/HCV coinfection; HCV treatment; opioid replacement therapy
4.  African American Patient Experiences with a Rapid HIV Testing Program in an Urban Public Clinic 
Of 1,174 new HIV cases diagnosed in Philadelphia in 2008, 771 (66%) were among African Americans. In 2007, Philadelphia introduced a citywide rapid HIV testing program in public clinics.
We conducted a prospective qualitative study among 60 African Americans undergoing rapid HIV testing in one of Philadelphia’s public clinics located in a zipcode with high HIV incidence. Employing grounded theory, we used semi-structured interviews to assess patients’ motivations, perceptions and clinical experiences with rapid HIV testing. Interviews were transcribed and coded; 20% were double coded to enhance reliability.
Primary motivations for undergoing rapid HIV testing included: testing during routine clinical care, presenting for care with symptomatic STIs or opportunistic infections, knowing someone living with HIV/AIDS, and perceiving oneself at risk for HIV. Most patients reported positive experiences with rapid testing and preferred it to conventional testing because it eliminated the need for return visits and decreased anxiety; however, many expressed concerns about accuracy of rapid HIV testing. Barriers to HIV testing among this population included low self-perceived risk, HIV stigma and reported homophobia in respondents’ communities.
This rapid testing program was acceptable, convenient, and preferred over conventional HIV testing. Providing educational information about rapid and confirmatory HIV testing may further enhance acceptability of rapid HIV testing in this population. Nationwide expansion of rapid HIV testing in public health centers is an important and acceptable means of achieving President Obama’s National AIDS Strategy goals of reducing racial disparities in HIV infection and HIV/AIDS treatment services.
PMCID: PMC4203368  PMID: 22708242
Rapid HIV testing; African American; HIV/AIDS
5.  Adherence to HIV treatment and care among previously homeless jail detainees 
AIDS and behavior  2013;17(8):2654-2666.
HIV-infected persons entering the criminal justice system (CJS) often experience suboptimal healthcare system engagement and social instability, including homelessness. We evaluated surveys from a multisite study of 743 HIV-infected jail detainees prescribed or eligible for antiretroviral therapy (ART) to understand correlates of healthcare engagement prior to incarceration, focusing on differences by housing status. Dependent variables of healthcare engagement were: 1) having an HIV provider, 2) taking ART, and 3) being adherent (>95% of prescribed doses) to ART during the week before incarceration. Homeless subjects, compared to their housed counterparts, were significantly less likely to be engaged in healthcare using any measure. Despite Ryan White funding availability, insurance coverage remains insufficient among those entering jails, and having health insurance was the most significant factor correlated with having an HIV provider and taking ART. Individuals interfacing with the CJS, especially those unstably housed, need innovative interventions to facilitate healthcare access and retention.
PMCID: PMC3325326  PMID: 22065234
HIV; AIDS; Homelessness; jail; incarceration; substance abuse; alcohol; insurance; Adherence; healthcare access
6.  Jails: The New Frontier. HIV Testing, Treatment, and Linkage to Care After Release 
AIDS and behavior  2013;17(0 2):10.1007/s10461-013-0552-7.
PMCID: PMC3876465  PMID: 23975472
7.  Changes in HIV-1 Subtypes B and C Genital Tract RNA in Women and Men After Initiation of Antiretroviral Therapy 
Fiscus, Susan A. | Cu-Uvin, Susan | Eshete, Abel Tilahun | Hughes, Michael D. | Bao, Yajing | Hosseinipour, Mina | Grinsztejn, Beatriz | Badal-Faesen, Sharlaa | Dragavon, Joan | Coombs, Robert W. | Braun, Ken | Moran, Laura | Hakim, James | Flanigan, Timothy | Kumarasamy, N. | Campbell, Thomas B. | Klingman, Karin L. | Nair, Apsara | Walawander, Ann | Smeaton, Laura M. | De Gruttola, Victor | Martinez, Ana I. | Swann, Edith | Barnett, Ronald L. | Brizz, Barbara | Delph, Yvette | Gettinger, Nikki | Mitsuyasu, Ronald T. | Eshleman, Susan | Safren, Steven | Andrade, Adriana | Haas, David W. | Amod, Farida | Berthaud, Vladimir | Bollinger, Robert C. | Bryson, Yvonne | Celentano, David | Chilongozi, David | Cohen, Myron | Collier, Ann C. | Currier, Judith Silverstein | Eron, Joseph | Firnhaber, Cynthia | Flexner, Charles | Gallant, Joel E. | Gulick, Roy M. | Hammer, Scott M. | Hoffman, Irving | Kazembe, Peter | Kumwenda, Johnstone | Kumwenda, Newton | Lama, Javier R. | Lawrence, Jody | Maponga, Chiedza | Martinson, Francis | Mayer, Kenneth | Nielsen, Karin | Pendame, Richard B. | Ramratnam, Bharat | Rooney, James F. | Sanchez, Jorge | Sanne, Ian | Schooley, Robert T. | Snowden, Wendy | Solomon, Suniti | Tabet, Steve | Taha, Taha | Uy, Jonathan | van der Horst, Charles | Wanke, Christine | Gormley, Joan | Marcus, Cheryl J. | Putnam, Beverly | Ntshele, Smanga | Loeliger, Edde | Pappa, Keith A. | Webb, Nancy | Shugarts, David L. | Winters, Mark A. | Descallar, Renard S. | Sharma, Jabin | Poongulali, S. | Cardoso, Sandra Wagner | Faria, Deise Lucia | Berendes, Sima | Burke, Kelly | Kanyama, Cecelia | Kayoyo, Virginia | Samaneka, Wadzanai P. | Chisada, Anthony | Santos, Breno | La Rosa, Alberto | Infante, Rosa | Balfour, Henry H. | Mullan, Beth | Kim, Ge-Youl | Klebert, Michael K. | Mildvan, Donna | Revuelta, Manuel | Jan Geiseler, P. | Santos, Bartolo | Daar, Eric S. | Lopez, Ruben | Frarey, Laurie | Currin, David | Haas, David H. | Bailey, Vicki L. | Tebas, Pablo | Zifchak, Larisa | Sha, Beverly E. | Fritsche, Janice M.
Women with human immunodeficiency virus (HIV)–1 subtype C had significantly higher genital tract viral loads compared to women with HIV-1 subtype B and men with HIV-1 subtype C or B. Women in general were significantly less likely to have genital tract viral load below the lower limit of quantification compared to men.
Background. Combination antiretroviral therapy (cART) reduces genital tract human immunodeficiency virus type 1 (HIV-1) load and reduces the risk of sexual transmission, but little is known about the efficacy of cART for decreasing genital tract viral load (GTVL) and differences in sex or HIV-1 subtype.
Methods. HIV-1 RNA from blood plasma, seminal plasma, or cervical wicks was quantified at baseline and at weeks 48 and 96 after entry in a randomized clinical trial of 3 cART regimens.
Results. One hundred fifty-eight men and 170 women from 7 countries were studied (men: 55% subtype B and 45% subtype C; women: 24% subtype B and 76% subtype C). Despite similar baseline CD4+ cell counts and blood plasma viral loads, women with subtype C had the highest GTVL (median, 5.1 log10 copies/mL) compared to women with subtype B and men with subtype C or B (4.0, 4.0, and 3.8 log10 copies/mL, respectively; P < .001). The proportion of participants with a GTVL below the lower limit of quantification (LLQ) at week 48 (90%) and week 96 (90%) was increased compared to baseline (16%; P < .001 at both times). Women were significantly less likely to have GTVL below the LLQ compared to men (84% vs 94% at week 48, P = .006; 84% vs 97% at week 96, P = .002), despite a more sensitive assay for seminal plasma than for cervical wicks. No difference in GTVL response across the 3 cART regimens was detected.
Conclusions. The female genital tract may serve as a reservoir of persistent HIV-1 replication during cART and affect the use of cART to prevent sexual and perinatal transmission of HIV-1.
PMCID: PMC3689341  PMID: 23532477
HIV-1 genital tract RNA; HIV-1 subtypes B and C; antiretroviral drugs
8.  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.
PMCID: PMC3601577  PMID: 23379422
African Americans; HIV/AIDS; health disparities; faith community; clergy; pastors
9.  Short Communication: New HIV Infections at Southern New England Academic Institutions: Implications for Prevention 
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.
PMCID: PMC3537304  PMID: 22724920
10.  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.
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.
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.
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.
Active TB at ART initiation was associated with increased risk of mortality in HIV-1 infected patients.
PMCID: PMC3877069  PMID: 24391801
11.  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.
PMCID: PMC3818019  PMID: 23673792
Substance abuse; Jail; Prisoners; Engagement in HIV care; Antiretroviral therapy; Adherence; Criminal Justice; Prisoners
12.  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.
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.
PMCID: PMC3682655  PMID: 23221766
HIV/AIDS; criminal justice system; jail; prison; HIV testing; transitional case management; substance abuse
13.  Clinical Impact and Cost-Effectiveness of Expanded Voluntary HIV Testing in India 
PLoS ONE  2013;8(5):e64604.
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.
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).
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.
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.
PMCID: PMC3669338  PMID: 23741348
14.  HIV testing practices among New England college health centers 
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.
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.
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.
Improved HIV testing practices are needed on college campuses. Programs should focus on outreach efforts targeting MSM and other at-risk populations.
PMCID: PMC3606211  PMID: 23496891
HIV; College; STI; Prevention
15.  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.
PMCID: PMC3182285  PMID: 21499794
Quality of life (QOL); Highly active antiretroviral therapy (HAART); HIV
16.  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.
PMCID: PMC3243921  PMID: 21873325
HIV; Cognition; Neuropsychology; Executive function; Recent clinical history
17.  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.
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).
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 NCT00084136
Please see later in the article for the Editors' Summary.
Editors' Summary
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
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; 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
PMCID: PMC3419182  PMID: 22936892
18.  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.
PMCID: PMC3353968  PMID: 22615756
19.  Safety, Tolerability, and efficacy of second-line generic protease inhibitor containing HAART after first-line failure among South Indian HIV-infected patients 
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.
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.
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.
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.
PMCID: PMC3128549  PMID: 21266320
HIV; AIDS; India; HAART; second-line therapy; protease inhibitors
20.  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.
PMCID: PMC3060905  PMID: 21252140
21.  HIV Treatment Outcomes Among HIV-Infected, Opioid-Dependent Patients Receiving Buprenorphine/Naloxone Treatment within HIV Clinical Care Settings: Results From a Multisite Study 
Having opioid dependence and HIV infection are associated with poor HIV-related treatment outcomes.
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.
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.
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.
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
22.  Comparisons of anemia, thrombocytopenia, and neutropenia at initiation of HIV antiretroviral therapy in Africa, Asia, and the Americas 
Hematological abnormalities are common manifestations of advanced HIV-1 infection that could affect the outcomes of highly-active antiretroviral therapy (HAART). Although most HIV-1-infected individuals live in resource-constrained countries, there is little information about the frequency of hematological abnormalities such as anemia, neutropenia, and thrombocytopenia among individuals with advanced HIV-1 disease.
This study compared the prevalence of pre-antiretroviral therapy hematological abnormalities among 1571 participants in a randomized trial of antiretroviral efficacy in Africa, Asia, South America, the Caribbean, and the USA. Potential covariates for anemia, neutropenia, and thrombocytopenia were identified in univariate analyses and evaluated in separate multivariable models for each hematological condition.
The frequencies of neutropenia (absolute neutrophil count ≤ 1.3 × 109/l), anemia (hemoglobin ≤ 10 g/dl), and thrombocytopenia (platelets ≤ 125 × 109/l) at initiation of antiretroviral therapy were 14%, 12%, and 7%, respectively, and varied by country (p < 0.0001 for each). In multivariable models, anemia was associated with gender, platelet count, and country; neutropenia was associated with CD4+ lymphocyte and platelet counts; and thrombocytopenia was associated with country, gender, and chronic hepatitis B infection.
Differences in the frequency of pretreatment hematological abnormalities could have important implications for the choice of antiretroviral regimen in resource-constrained settings.
PMCID: PMC3021118  PMID: 20961784
HIV; Anemia; Neutropenia; Thrombocytopenia; Resource-limited countries
23.  Cost-Effectiveness of Tenofovir as First-Line Antiretroviral Therapy in India 
World Health Organization guidelines for antiretroviral treatment (ART) in resource-limited settings recommend either stavudine or tenofovir as part of initial therapy. We evaluated the clinical outcomes and cost-effectiveness of first-line ART using tenofovir in India, compared to current practice using stavudine or zidovudine.
We used a state-transition model of HIV disease to examine strategies using different nucleoside reverse transcriptase inhibitors, combined with lamivudine and nevirapine, compared to no ART: 1) stavudine; 2) stavudine, with substitution by zidovudine after six months; 3) zidovudine; 4) tenofovir. Data were from the Y.R. Gaitonde Centre for AIDS Research and Education in Chennai, India and published studies.
Discounted mean per person survival was 36.9 months (40.1 months undiscounted) with no ART, 115.5 months (145.3) with stavudine-containing ART, 115.6 months (145.5) with stavudine and six-month zidovudine substitution, 115.7 months (145.6) with zidovudine-containing ART, and 125.9 months (162.2) with initial tenofovir. Discounted lifetime medical costs were $610 with no ART and ranged from $5,560 with stavudine-containing ART to $5,720 with zidovudine-containing ART. Initial tenofovir had an incremental cost-effectiveness ratio of $670/year of life saved compared to no ART and was more economically efficient than the other regimens. Results were most sensitive to variations in the costs of first-line tenofovir, access to additional ART after failure, mean initial CD4 count, and quality of life adjustment.
Using tenofovir as part of first-line ART in India will improve survival, is cost-effective by international standards, and should be considered for initial therapy for HIV-infected patients in India.
PMCID: PMC3225050  PMID: 20043752
HIV; cost-effective; India; antiretroviral treatment; resource-limited settings
24.  Sex-associated Differences in Pre-Antiretroviral Therapy Plasma HIV-1 RNA in Diverse Areas of the World Vary by CD4 Cell Count 
Antiviral therapy  2011;16(7):1057-1062.
Sex differences in the natural history of HIV infection may vary between resource-rich and resource-limited settings.
Baseline characteristics from a randomized clinical trial of treatment naïve subjects conducted at sites in Africa, Asia, the Caribbean, and North and South America were analyzed to determine if there were significant differences by sex.
Of the 1571 participants, 740 (47.1%) were women. Women had higher mean screening CD4 cell counts (average 15 cells higher, (p<0.001), lower mean hemoglobin and creatinine clearance, a lower mean baseline HIV-1 viral load (4.85 log10 vs. 5.05 log10 copies/mL (P<0.001)) and were less likely to have a prior AIDS diagnosis than men. The sex difference in viral load difference was related to CD4 cell count, however it was independent of country and persisted within the strata with CD4 < 200 cells/mm3.
Women in resource limited settings have lower levels of plasma HIV-1 RNA and appear to present for enrollment into a clinical trials at an earlier stage of disease than men. The biologic basis for lower viral in women compared to men remains unexplained. It will be important to determine if the sex differences observed at baseline impact clinical outcomes once the PEARLS clinical trial is completed.
PMCID: PMC3205462  PMID: 22024521
viral load; sex; international; clinical trial; CD4 cell count
25.  Follow-Up Care Among HIV-Infected Pregnant Women in Mississippi 
Journal of Women's Health  2010;19(10):1863-1867.
Data from the Centers for Disease Control and Prevention (CDC) indicate that reproductive-age black women in the Southeast are disproportionately affected by the HIV epidemic. There are few data describing HIV infection, pregnancies, and follow-up care in this population.
A retrospective chart review was performed at the Perinatal HIV Service at the University of Mississippi Medical Center in Jackson, Mississippi, to identify HIV-infected women ≥18 years of age with deliveries from 1999 to 2006. Optimal follow-up was defined as at least two follow-up visits with an HIV provider within 1 year of delivery. Univariate and multivariate logistic regression analyses were used to identify factors associated with optimal adherence.
We identified 274 women with 297 total deliveries. Median age was 25, and 89% were black. Only 37% of women had two or more visits with an HIV provider in the postpartum year. On univariate analysis, presentation before the third trimester was associated with optimal follow-up (p = 0.04). On multivariate analyses, presentation before the third trimester was the only variable associated with optimal follow-up (odds ratio [OR] 2.1, p = 0.02).
The poor follow-up rates in this growing population highlight the critical need for research and development of targeted interventions to improve rates of retention in care, particularly in women with late trimester presentation.
PMCID: PMC2965694  PMID: 20831428

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