In this issue:

• People
• ACASI Follow-up Launched
• Recent Research Findings
• Studies and Grants Updates

At Johns Hopkins, new study coordinator Travis Brown came on board in April, 2006. Travis came to TNC as a graduate of Towson University in Baltimore, MD. Having made a great running start, he is now well-established in the clinic. Here’s more from Travis in his own words:

Travis Brown

"The reason I became interested in research was because of the internship I had as a senior in college. I was in the position of research assistant at the University of Maryland in Downtown Baltimore. I did not like the institution where I was placed but I greatly enjoyed the work that I was doing and the fact that I could apply the skills I was taught in college.

When first introduced to the TNC Study, I was very nervous. It seemed like so much information to retain and much I had to adjust to. However, I had the best trainer in Jane Lanzillotti. She assured me that I would be fine and helped me so much. Now that I am settled, this is a piece of cake. I am so confident in what I do now and that fear is no longer there. I have a great appreciation for the TNC Study and its purpose for the future."

Tim Flanigan, MD

From Brown, we were happy to hear that TNC-CDAAR member Timothy Flanigan, MD, was honored in October with the 2006 HIVMA Advocacy Award. This award recognizes an HIVMA member who has made important contributions to sound HIV/AIDS policy at the local, state, national, or international levels in the area of prevention, research, or access to care. It is based on the level and nature of advocacy activities, and the importance of the effort to improving the lives of persons living with or at risk for HIV/AIDS. Dr. Flanigan’s work centers on improving treatment access, standards of care, and outcomes in HIV-positive substance abusers, prisoners, and other marginalized populations. He has pioneered innovative programs utilizing a comprehensive approach. Incarcerated individuals, for example, receive as needed HAART, vaccinations, and Hepatitis C treatment. Upon release, they are provided continuity of health care as well as access to social and financial resources to reduce recidivism and reincarceration. We congratulate him for his committed and caring work and celebrate his recognition by the HIVMA.

In news from Tufts, you may already know that Jane Lanzillotti, Project Manager, left Tufts for a new opportunity at the Harvard Clinical Research Institute. We wish her well in her new endeavor. Her project manager responsibilities will be shared between Kimberly Dong and Christina McCormack. Both have contributed greatly to projects at Tufts in the past, Kim as a research nutritionist since 2003 and Christina as a Project Manager since 1994. Kim & Christina are working with Scott Sughrue to update the TNC website in its new location as part of the Nutrition/Infection Unit site, along with Alison Otis, who has worked on newsletters and websites for Tufts since 1998 (and who provides the English audio for the ACASI questionnaire), who will also create periodic e-newsletters like this one.

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ACASI questionnaire samples

The ACASI version of the follow-up questionnaire was implemented smoothly at our TNC Study sites in Baltimore, Providence and Boston. We encountered some interesting programming challenges as we tried to create a smooth transition for study coordinators and participants resulting in optimal data collection. For anyone unfamiliar with the ACASI questionnaire, some sample screenshots are pictured at right. If you are curious about what it’s like to use ACASI and you’re at one of our ACASI sites, ask to take a test run. It’s always helpful to get feedback from people who have never tried it.

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This abstract comes from the parent study at Tufts, BIENESTAR. Commentary from the Principal Investigator, Janet Forrester, Ph.D., follows.

Forrester JE, Tucker KL, Gorbach SL. The effect of drug abuse on body mass index in Hispanics with and without HIV infection. Public Health Nutr. 2005 Feb;8(1):61-8.

ABSTRACT:

OBJECTIVE: There is a widely held view that the lower weight of drug abusers is attributable to diet. However, many studies on the dietary intake of drug abusers have failed to find energy insufficiency, while non-dietary factors have rarely been examined. The purpose of this study was to examine non-dietary factors that could affect the weight of drug abusers with and without HIV infection.
DESIGN: Participants were recruited into one of three groups: HIV-positive drug abusers (n=85), HIV-negative drug abusers (n=102) and HIV-positive persons who do not use drugs (‘non-drug abusers’, n=98). Non-dietary factors examined included infection with HIV and/or hepatitis, malabsorption, resting energy expenditure and physical activity.
SETTING: The baseline data from a prospective cohort study of the role of drug abuse in HIV/AIDS weight loss conducted in Boston, USA.
SUBJECTS: The first 286 participants to enroll in the study.
RESULTS: HIV-positive drug abusers had a body mass index (BMI) that was significantly lower than that of HIV-positive non-drug abusers. The differences in weight were principally differences in fat. In the men, cocaine abuse, either alone or mixed with opiates, was associated with lower BMI, while strict opiate abuse was not. Infection with HIV or hepatitis, intestinal malabsorption, resting energy expenditure and physical activity, as measured in this study, did not explain the observed differences in weight and BMI.
CONCLUSIONS: Drug abuse, and especially cocaine abuse, was associated with lower weight in men. However, infection with HIV and/or hepatitis, malabsorption and resting energy expenditure do not explain these findings.

COMMENTARY:

According to Forrester, the clinical implications of these findings are that drug abusers, particularly cocaine abusers, should be monitored for weight loss and referred for dietetic consultation if appropriate. For future research, Forrester points to the need for longitudinal studies looking at whether drug abusers are losing weight over time, or simply failing to gain weight.

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The Center Grant

The Center Grant, which will reach its five-year mark in July 2007, will be resubmitted in January. The resubmission will include the new research area of co-infection with Hepatitis.

TNC-CDAAR Domestic

Our U.S. multi-site TNC Study looking at nutrition and metabolic abnormalities among HIV-infected drug users is nearly 2/3 of the way toward meeting the overall participant enrollment goal. Participants of white, Hispanic and African-American ethnicity are well represented in the overall recruitment from the three sites, Boston, Providence and Baltimore. Eligibility for the study includes the requirement that all participants have injected, smoked or snorted heroin, crack, cocaine, or methamphetamines in the last 5 years. For more study details, see the reports below.

TNC-CDAAR International

Our TNC-CDAAR studies are well underway in three international locations: Chennai, India; Hanoi, Vietnam; and Buenos Aires, Argentina. While our specific aims are similar to those of our domestic studies, there are distinct research issues in the international arena.

• With international government initiatives to provide highly active antiretroviral therapy (HAART) medications to patients, regimens are being implemented in a much more standardized way than they were in the developed world. This provides the opportunity to examine the effect of individual antiretroviral drugs or a particular class of drug.

• There is concern that some patients may abandon treatment due to difficult side effects. One of the goals of TNC-CDAAR is to provide education and training to patients, caregivers, and physicians on how to deal with side effects of the medications in order to optimize therapy.

• Another important goal is to obtain baseline nutrition and metabolic data on patients prior to initiation of HAART. This information could be used to modify treatment regimens in order to maximize antiviral response and minimize complications, both internationally and in the U.S.

Below are details of each project, with status updates:

 

SAHAI Trust

Chennai, India

As of February 2004, the government of India has agreed to provide HAART medication to HIV-infected individuals. Although the majority of HIV cases in India are due to heterosexual transmission, escalating drug use in selected regions of the country are associated with high rates of HIV infection. The primary drugs of choice in this drug-using population are heroin and buprenorphine. The study will enroll 200 HIV-positive and 200 HIV-negative drug-using clients who regularly attend SAHAI Trust, a network of drug treatment centers in Chennai. SAHAI Trust is a recognized presence in the drug use community, having worked for years with drug users in Chennai.

Status Update:

The India site began staff training on November 6, 2006. Tufts medical student Aparna Dandekar, who arrived in Chennai in October, is helping coordinate the launch of the study during her six-month stay.

 

Educational poster at SAHAI Trust

Tufts investigators meet with NIITD researchers and staff in Hanoi.

Hanoi, Vietnam

In June 2004, Vietnam became eligible for funding of HAART treatment expansion through the President’s Emergency Plan for AIDS Relief (PEPFAR). HIV infection in Vietnam has spread dramatically, especially among injection drug users (IDUs), fueled by poor social conditions and a trend away from smoking opium to injecting heroin. We are conducting our study in North Vietnam because that is where the HIV epidemic is rapidly emerging directly due to injection drug use, primarily of heroin. The study of 200 HIV-positive (100 stable on HAART for 6 months, and 100 HAART-naïve but likely to start HAART within 6 months) and 100 HIV-negative drug users will take place at the National Institute of Infectious and Tropical Diseases (NIITD).

Status Update:

Kristy Hendricks, Associate Professor in the Nutrition/Infection Unit at Tufts, traveled to Vietnam in October, 2006, to work on nutrition data collection issues. In order for us to properly analyze the nutrition data from Vietnam, we have been expanding our database with the appropriate ingredients and recipes. Kristy returned with about 100 24-hour recalls that will be entered for dietary analysis by Nutrition Data Coordinator Jeanette Queenan.

 

Kristy worked with Vietnamese colleagues to create a reference book of standardized portions for nutrition data collection, pictured at left.

Tufts and Argentinian colleagues in Buenos Aires

Buenos Aires, Argentina

Although there remains a large concentration of injection drug users in major cities, especially in and around Buenos Aires, an alarming rise in the smoking of coca paste – an intermediate product in the processing of coca leaves into powder cocaine – seems to be leading to a decline in HIV transmission through injection drug use in Argentina. It is reported that coca paste smokers experience rapid weight loss, and yet, few, if any, research studies have examined the nutritional and metabolic status or HIV risk factors in this rapidly increasing group. The study aims to recruit 90 HIV-positive and 190 HIV-negative participants from FUNDAI, a non-profit HIV/AIDS organization, and CENARESO, a provider of inpatient and outpatient services for drug addiction. We estimate that 180 of the 280 participants will be using coca paste as their primary drug of choice.

Status Update:

The study is finishing up this month, having recruited 207 participants. A new grant has been submitted regarding non-injecting coca paste of cocaine (CPC) users, with the objectives of 1.) quantifying the prevalence of HIV and other STIs among CPC users in Buenos Aires; 2.) identifying the characteristics and factors of CPC users at highest risk of acquiring and transmitting these diseases; and 3.) gathering information on the medical and nutritional consequences of CPC use.

 

Staff training session in Argentina

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