BETHESDA, MD—At the Infectious Disease Clinical Research Program (IDCRP), headquartered at the Uniformed Services University of the Health Sciences, researchers are in the business of asking tough questions and then going after the answers. “We are not a funding agency. We are not a granting agency, where people bring ideas and we fund them. We are a research organization that works in collaboration with others to conduct investigations,” Brian Agan, MD, director of IDCRP’s HIV/STI Working Group (WG), said of IDCRP.

HIV is an important area of research for the military. IDCRP’s HIV/STI WG is conducting and collaborating on HIV clinical research in order to better understand the disease in the military setting and to impact DoD policy, Agan explained.

For example, in 2009, when H1N1 was causing angst among public health officials, IDCRP researchers wanted to know how the H1N1 vaccine would effect those with HIV, so they initiated a study comparing the response to the H1N1 vaccine in HIV-infected versus uninfected individuals. The concept for the study was conceived in August of 2009 and quickly evolved into a study with the analysis completed and the primary manuscript accepted for publication in June, 2010.

Agan said that rapidly responding to infectious diseases is what IDCRP aims to do. “The idea of rapid response is part of our mission.”

Studying HIV

The jewel of the IDCRP’s HIV/STI WG is the US Military HIV National History Study (NHS). The study, which was initiated in 1986 at the US Military HIV Research Program, is an observational ongoing cohort study that includes nearly 25 years of longitudinal data and specimens from over 5,000 HIV-infected DoD beneficiaries. The study has open enrollment of military members and beneficiaries with HIV infection.

The NHS, which is funded by NIAID, has made it possible for researchers to examine a number of HIV questions over the years. “It has really been a boon to the study of HIV,” said Agan, who pointed to the hundreds of publications, studies, and collaborations that the NHS has helped generate.

Data for the study is collected from both HIV-positive beneficiaries and active duty patients who are evaluated every six months at seven MTFs. The aliquots of PBMC, serum, and plasma drawn from those participating in the study are stored in a tissue repository for future research, including genetic studies. “So what we have is a unique resource of clinical data and specimens on all of these participants going back 25 years,” noted Agan.

Agan said that one factor that makes the ongoing study so beneficial to HIV research is that the cohort is racially balanced with approximately 45% European American, 45% African American, and 8% Hispanic participants.

Another factor that benefits HIV research is the DoD population tends to have a relatively stable income, high level of education, minimal drug abuse, and open access to healthcare with free medications, according to Agan. So many of the socioeconomic confounders that can skew certain HIV studies are minimized in this setting.

The data the HIV/STI WG collects has allowed IDCRP to form partnerships with a variety of investigators to examine different HIV questions and has benefitted HIV work beyond DoD, according to Agan. One example of this was the use of data and analyses from the NHS cohort in the Institute of Medicine report to the US Social Security Administration regarding updating the HIV disability listings, noted Agan. The DoD HIV cohort was the only single cohort with mortality data cited in the report.

Agan said that the data and analyses show that HIV is not the same disease as it was 10 years ago. Furthermore, low CD4 counts, even with modern therapy offered today, is still a bad prognostic factor. The IoM report will help shape outcomes at a national level
regarding the benefits delivered to those with HIV infection.

Tackling HIV/STI Prevention

HIV/STI WG recently expanded into HIV/STI prevention. Researchers are aiming to understand prevalence, incidence, and risk factors for HIV/STI in order to target prevention interventions in the military setting.

Future protocols are planned by the program to include conducting HIV/STI prevention trials with both HIV seropositive and at-risk individuals, and studying the effectiveness of current DoD HIV/STI prevention programs.

The IDCRP has also organized and has continued to support the DoD HIV/STI Prevention Working Group which includes representation from twenty organizations in three military services as well as Health Affairs and NIAID.

back to December articles