In this issue:

• People and Projects
• Recent Research Findings
• Grants and Studies Updates
• Core Services Available

Sherwood L. Gorbach, MD

Dr. Gorbach Honored by IDSA Society
Sherwood L. Gorbach, MD, Principle Investigator and Director of TNC-CDAAR, has been honored with the Alexander Fleming lifetime achievement award from the Infectious Diseases Society of America. The award, named after the discoverer of penicillin, is granted to an IDSA member or fellow in recognition of a career that reflects major contributions to the acquisition and dissemination of knowledge about infectious diseases. We congratulate him on this remarkable accomplishment.

ACASI Questionnaire System: New Demo, New Projects
A brief, interactive ACASI (Audio Computer-Assisted Self-Interview) Demo has been created to demonstrate how ACASI questionnaire systems can be custom built for research studies. The ACASI Demo is available for download from our website. When Alice Tang, PhD, traveled to Australia for the IAS Conference in July, she brought along ACASI Demo CDs and brochures which received much interest.

Two international projects involving ACASI are in the planning stages:

ACASI questionnaire sample

In early November, ACASI Programmer Scott Sughrue and Senior Statistical Programmer Sally Skinner will travel to Hanoi, Vietnam, to train staff programmers at the Hanoi School of Public Health (HSPH) in ACASI questionnaire development, in an arrangement with Linh C. Le, MD, PhD, of the HSPH.

In India, a CFAR-supported study in Hyderabad, Adhra Pradesh, will utilize an ACASI questionnaire to be built at Tufts by Scott Sughrue. The study, led by John Schneider, MD, MPH, who is being mentored by TNC-CDAAR member Ken Mayer, MD, aims to develop the foundation for studies of potential HIV and STI prevention packages and scenarios in which they can be implemented in the understudied population of truck drivers and cleaners, thought to be at high risk for HIV infection in the state of Andhra Pradesh. This study in truck drivers will be the largest ever in India (and Asia) and will give a more accurate representation of the Indian population of truck drivers given the avoidance of subject recruitment from traditionally high risk areas such as dhabas (local restaurants), brothels, or overnight state border checkpoints. ACASI has the potential for increased accuracy over traditional face to face interviewing in this setting.

Miriam/Brown-University of Mississippi Collaboration on HIV+ Women
With support from TNC-CDAAR, Miriam Hospital Immunology Center at The Warren Alpert Medical School of Brown University, in conjunction with the University of Mississippi School of Medicine, is initiating a project to examine the long-term morbidity associated with HIV infection in post-partum women in Mississippi. In the last ten years, with the advent of highly active antiretroviral therapy (HAART), the rate of vertical transmission from pregnant woman to child has dropped to under one percent. This is magnificent news, which should be celebrated. On the other hand, much of the attention has focused away from HIV-positive pregnant women, who still face the tremendous burden of HIV.

Most women with HIV infection in the United States (and particularly in Mississippi) are poor and are African American. Many of them have a history of substance use, or have suffered the harm of substance use in their husbands, partners, boyfriends, and other family members. The burden of HIV in the African American community is enormous, particularly among women. The aim of this project is to follow women with HIV infection over ten years to determine long-term morbidity and health needs. Over 90% of the women with HIV infection who are pregnant or post-partum in Mississippi are African American. Many will be single mothers. Many suffer from morbidity related to prior cocaine use, or heavy alcohol use. Substance use is a chronic relapsing disorder, and continues to pose long-term challenges for many women suffering from HIV. In addition, there is a higher prevalence of metabolic disorders such as insulin resistance and diabetes mellitus among African Americans, particularly in the southern United States, usually corresponding with higher rates of obesity.

The purpose of this study will be to examine social support, access to care, adherence to antiretroviral therapy, frequency of mental illness, and the prevalence and consequences of substance abuse (particularly Hepatitis B and C) both in women who are HIV-infected, as well as their family members. This study will also collect data on metabolic complications and nutritional status, especially in relation to exercise and functional ability. Health literacy and self efficacy will be evaluated on an ongoing basis. It is hoped that this project will provide the information necessary to lead to community-based interventions that will improve the quality of life and decrease morbidity in reproductive age women with HIV in Mississippi.

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Five abstracts representing our research were presented at the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention incorporating the 19th ASHM Conference which took place July 22-25, 2007, in Sydney, Australia. Tufts attendees at the conference included Alice Tang, PhD; Hanh La, PhD; Lien Quach, MD, MPH; Michael Jordan, MD, MPH; and Alexandra Mangili, MD, MPH.

La H, Tang A, Nguyen H, Trinh L, Dang D, Hellinger J, Quach L, Sheehan H, Jordan M. Correlation of visual analog scale and 2-week self report of ART adherence among drug users in Hanoi,Vietnam. Abstract #CDB341.
Muzzio E, Benetucci J, Redini L, Hellinger J, Jordan M, Naveira J, Segura M, Gabriel D, Sheehan H, Tang AM, Weissenbacher M. Infectious consequences in injecting and non-injecting polysubstance drug users in Buenos Aires, Argentina. Abstract #CDB459.
Quach LA, Tang AM, Schmid CH, Gorbach SL, Wanke C. The role of cigarette smoking on HIV/AIDS mortality. Abstract #TUPEB096.
Rhee M, Schmid C, Stevens L, Tang AM, Forrester J. Risk factors for proteinuria in HIV-infected and -uninfected Hispanic drug abusers. Abstract #MOPEB071.
Tang AM, Muzzio E, Naveira J, Segura M, Sheehan H, Benetucci J, Redini L, Weissenbacher M, Hellinger J. Factors associated with depressive symptoms among HIV-positive and HIV-negative drug users in Buenos Aires, Argentina. Abstract #CDB454.

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The CDAAR grant renewal was submitted September 7, 2007.

Proposed New Core: Hepatitis and Liver Function
The Hepatitis and Liver Function Core, a new Core in the TNC-CDAAR grant renewal currently under review, was developed in response to the needs of TNC-CDAAR investigators who are interested in studying the effects of hepatitis and liver disease on nutritional and metabolic outcomes in HIV infection. Given the high prevalence of chronic liver disease (both chronic hepatitis C (HCV) and chronic hepatitis B (HBV) infections) among persons with drug use and HIV, this important new Core will enable TNC-CDAAR researchers to incorporate the appropriate measures of liver function into their studies and account for liver disease when examining indicators of nutritional or metabolic status. Research has shown that hepatic fibrosis, cirrhosis, and decompensation of liver function progress faster in those with coinfection of HIV and chronic viral hepatitis. Despite improved survival from the advent of HAART, coinfected persons experience increased mortality from liver disease in HIV cohorts. Persons with coinfection have more HAART-related hepatotoxicity, are less likely to receive HAART because of fears of hepatotoxicity, and may experience an increased risk of infections and malignancies, particularly hepatocellular carcinoma. Our investigators recognize that the presence of chronic and progressive liver disease may have a significant contribution to the nutritional and metabolic status in drug users.

The Hepatitis and Liver Function Core brings together investigators from many centers who are studying drug-using populations with chronic liver disease, with and without HIV: women, including pregnant women, adolescents, African Americans, Hispanics, and correctional populations, as well as distinct international populations. Investigators will be able to compare risk factors in populations differing by race, gender, age, and exposure and support research to develop appropriate and specific interventions for those with chronic liver disease among these populations.

Recent data from some of our current TNC-CDAAR studies show a high prevalence of chronic viral hepatitis among HIV-positive and HIV-negative drug users:

• The Bienestar cohort of HIV-positive and HIV-negative Hispanic drug users and non-drug users in Boston shows that over 60% of the overall cohort have chronic viral hepatitis and 11% have cirrhosis by non-invasive indices.
  
• Preliminary analysis indicates that 87% of HIV-positive participants in the TNC-CDAAR Vietnamese cohort have chronic viral hepatitis.
  
• In Argentina, the TNC-CDAAR-initiated study found a 71% prevalence of chronic hepatitis infection in HIV-positive participants and 11% in HIV-negative participants.

The Core will offer centralized, standardized services to TNC-CDAAR members studying facets of liver disease and hepatic function in drug users in studies of nutrition and metabolism. This will include: a standard panel of hepatic serology; guidelines for the use of confirmation of chronic viral hepatitis testing including testing for HCV viremia in persons with drug use and CD4+ counts <200 cells/ml; recommendations for fibrosis markers in chronic liver disease; and measures of hepatic function supported by the Core. It will be able to assist investigators who seek to integrate liver disease data into the data collected in the multiple populations through the links set up by this Center. The Hepatitis and Liver Function Core will also provide education, training, and outreach through Core personnel.

Core personnel include Director Tamsin A. Knox, MD, MPH (Tufts), Co-director Lynn Taylor, MD (Brown), and Core Investigator Shruti Mehta, PhD (Johns Hopkins), along with additional consultants and consulting laboratories.

TNC DOMESTIC

Kimberly Dong, Travis Brown and Katie Coop on a lunch break

Study Update
Study coordinators Travis Brown from Johns Hopkins and Katie Coop from Brown visited Boston in March 2007 to meet the whole Boston team and learn more about what happens to the data they have collected.

Study visits continue at the sites in Boston, Providence and Baltimore. At this time, the emphasis is on follow-up visits. See the tables below for updated demographic and substance use data.

Table 1. Baseline demographic and health characteristics of 513 participants enrolled in the Tufts Nutrition Collaborative (TNC) study

Table 2. Burden of substance use reported by 513 participants of the Center-wide study

TNC INTERNATIONAL

HANOI, VIETNAM

Study Update
Tufts personnel have made productive visits to the TNC-CDAAR supported study at the National Institute of Infectious and Tropical Diseases (NIITD) at Bach Mai Hospital. In June 2007, Alice Tang and Hanh La visited Hanoi to work on the shipping of lab samples to Boston and strengthening study recruitment of the difficult-to-reach, HIV-negative drug users. Kimberly Dong and Hanh La travelled to the site in August 2007 to accomplish training and recertification of local staff. France Nguyen, a UCLA Fulbright Fellow and doctoral candidate in Social Welfare, completed a study of food insecurity in the NIITD-Tufts cohort for her doctoral dissertation.

Alice Tang and Hanh La visit with the Vietnam study team. From left: Ms. France Nguyen, Mr. Pham Hong Hai, Dr. Dang Van Duong, Dr. Nguyen Duc Hien, Dr. Alice Tang, Dr. Trinh Thi Minh Lien, Dr. Hanh La, Ms. Le Thi Hoa, Dr. Nguyen Vu Trung, Dr. Nguyen Thi Dung

Study visits are proceeding well, and recruitment (41/100) is moving along more rapidly for Group 3 (HIV-), with the majority now coming from the drug treatment program at the National Mental Health Institute on the Bach Mai campus. Group 1 (HIV+ on HAART) baseline and follow-up visits are mostly complete, and Group 2 (HIV+, about to start HAART) has completed 56/100 baseline and 22/100 follow-up visits.

Kim Dong trains personnel on anthropometric measurements.

The Tufts team has invited Dr. Hien (Director of NIITD), Dr. Lien (Clinic Director), and Dr. Duong (Consultant and Project Coordinator) to visit Boston from October 29 to November 2, 2007, to meet colleagues from Tufts and Brown and discuss future research and training opportunities. During the visit, Dr. Hien will give a lecture, “Experiences with Avian Influenza Management in Vietnam,” on Tuesday, October 30, at noon, in Posner Hall Auditorium. On Thursday, November 1, from 11 AM – 5 PM, Tufts faculty, along with speakers from Brown, Boston University, and Harvard, will present a seminar at Tufts, “HIV and Vietnam.”

CHENNAI, INDIA

Alice Tang cuts the ribbon to launch the opening of the TNC Study clinic at SAHAI Trust as Kimberly Dong and Dr. M. Suresh Kumar look on.

SAHAI Trust nutritionist Terin Mathai and Kimberly Dong discuss dietary recall data collection.

Study Update
Alice Tang and Kimberly Dong visited the National Institute of Epidemiology (NIE)-Tufts Study site in February 2007. With training sessions and a ribbon-cutting ceremony, they helped launch the opening of the study clinic at SAHAI Trust, a drug treatment center in North Central Chennai. Kristy Hendricks, ScD, followed in April to work on dietary data collection methods and the expansion of our international food database to include Indian nutritive data, as well as food security questions to be incorporated into the questionnaire.

The local study team rapidly completed the recruitment of 300 participants (108 HIV+/192 HIV-) for baseline visits. Follow-up visits will begin shortly. The first 100 dietary recalls have been shipped to Tufts for data entry by Jeanette Queenan.

Developmental Research Award
As recipients of a TNC-CDAAR Developmental Research Award, Dr. Mohan D. Gupte and his research staff in India, in collaboration with investigators from the Tufts University School of Medicine, will administer an additional study participant questionnaire to be conducted during TNC study visits for the grant, “Nutritional Status of HIV-Positive and HIV-Negative Injection Drug Users in Chennai, India.” The purpose of this questionnaire is to determine food security within the study population. A comparison analysis of food security in drug users in this site versus other sites will also be conducted.

BUENOS AIRES, ARGENTINA

Study Update
The study is complete at this time. Data analysis is in progress.

Developmental Research Award
As recipients of a TNC-CDAAR Developmental Research Award, Dr. Mercedes Weissenbacher and her research staff in Argentina, in collaboration with investigators from the Tufts University School of Medicine, will use sera samples from the cross-sectional serostudy conducted in 2006 in Argentina, “Nutritional Status of HIV-Positive and HIV-Negative Injection Drug Users in Buenos Aires, Argentina” to determine the prevalence of syphilis in this population. In addition, they will prepare a manuscript describing the prevalence of syphilis and co-infection with HIV, Hepatitis B (HBV), and/or Hepatitis C (HCV) and associated risk factors in this population of drug users.

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TNC-CDAAR Research Services
REMINDER: Core services are available to all TNC-CDAAR members. TNC-CDAAR investigators are available to collaborate and provide support with data analysis and nutrition/metabolic assessment relating to drug-using populations. Contact Kimberly Dong (kimberly.dong@tufts.edu) for more information.