HIV prevention scientists have long recognized that it is imperative to integrate behavioral and biomedical approaches to HIV prevention and care, but have often been impeded by disciplinary boundaries, disparate funding streams, and institutional barriers. Yet behavioral interventions are incomplete if they fail to incorporate the expanding array of biomedical advances, and without a focus on the behavioral, even the most advanced biomedical approaches are unlikely to reach their full potential.

With such concerns in mind, preparations are underway for a major new study to evaluate an intervention package for preventing HIV transmission within heterosexual couples using both behavioral and biomedical approaches. Led by the International Center for AIDS Care and Treatment Program (ICAP) at the Columbia University Mailman School of Public Health, this study brings together researchers from ICAP and the HIV Center. The study's Principal Investigator is Wafaa El-Sadr, M.D., M.P.H.,  ICAP Director and HIV Center Associate Director.  “The insights we gain through the pilot work and ultimately from the study can hopefully guide future efforts to stem transmission within serodiscordant couples and contribute to tackling HIV in Lesotho and similar settings,” said Dr. El-Sadr.

With funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH), the Enhanced Prevention in Couples (EPIC) Study is being conducted in Lesotho. An estimated one-quarter of adults in this small southern African country are HIV infected, and the country has the third highest HIV seroprevalence rate in the world. Transmission within heterosexual couples is a major contributor to the spread of the disease.

The EPIC Study will be conducting a series of feasibility studies to inform the development of an “Enhanced Prevention Package” among HIV-serodiscordant couples, i.e., those in which one partner is HIV-infected and the other is not. The Enhanced Prevention Package breaks new ground by including three major components that integrate biomedical and behavioral approaches.

The first component of the intervention package will be the offering of antiretroviral therapy (ART) to HIV-positive partners with CD4 cell counts below 500, which is at a higher CD4 count than is currently the standard of care in Lesotho. This part of the intervention will offer health benefits to the HIV-positive partners while also potentially lowering their infectiousness to the uninfected partners.

Second, the study will include couple-focused counseling for decreasing sexual risk behavior and enhancing adherence to HIV treatment and care.

The third core component of the intervention package will be the offering of male circumcision to HIV-negative men who have an HIV-positive partner. There are known benefits of male circumcision in preventing HIV acquisition. The couple would need to be counseled about how circumcision may affect their sexual life, including the timing of resuming sexual behavior post-circumcision.

The research team will determine the feasibility and acceptability of these intervention components while also

modeling the potential effects of the enhanced package to prevent HIV transmission in Lesotho and similar settings.

This new partnership builds on extensive previous work throughout the southern Africa region by both ICAP and the HIV Center.  ICAP is a global leader in supporting the scale-up of multidisciplinary HIV/AIDS prevention, care, and treatment programs based on a family-focused approach. Currently, ICAPsupports 818 sites in 14 resource-limited countries of sub-Saharan Africa and Asia, which provide HIV services to nearly 683,000 people, including antiretroviral treatment to more than 334,000 individuals. In addition, ICAP-supported sites have provided HIV counseling and testing services to nearly 600,000 pregnant women.  Since 2004, with funding from the U.S. Agency for International Development, ICAP has been working with the Lesotho Ministry of Health and Social Welfare and other partners to support HIV prevention, care and treatment programs.

The HIV Center also has an extensive portfolio of projects in South Africa, stretching back over 20 years, although not previously in Lesotho.  Currently, there are 10 active HIV Center studies in South Africa. (To read more about the HIV Center's global portfolio, click here. To read more about the HIV Center’s international projects, particularly in South Africa, click here.)

The EPIC Study includes a multidisciplinary team of researchers from ICAP and the HIV Center, where the lead investigators are Robert Remien, Ph.D., and Joanne Mantell, Ph.D., both of whom have extensive experience working in HIV behavioral research in southern Africa. Dr. Remien is currently Principal Investigator of the Masivukeni Project, a multimedia-based adaptation of his proven adherence intervention with serodiscordant couples, the SMART Couples Study.

“ICAP has played a leading role in the scale-up of HIV prevention, care, and treatment in sub Saharan Africa, while at the HIV Center we have a long history of developing and testing interventions to improve HIV care and prevent ongoing HIV transmission,” noted Dr. Remien. “The EPIC study allows the integration of biomedical and behavioral approaches to HIV prevention and HIV care in ways that have the potential to make a real difference in the epidemic in Lesotho and provide a model for other settings.”

Dr. Mantell is the Principal Investigator of two studies on attitudes towards patients' and health care providers' attitudes towards male circumcision as a tool for HIV prevention. She is also Principal Investigator of a structural intervention to integrate reproductive health into HIV care in clinics in South Africa and a female condom study among students at the University of KwaZulu-Natal.

Other key members of the research team include: Elaine Abrams, M.D., Director of Research at ICAP and professor of pediatrics and epidemiology; Raphael Ntumy, M.D., ICAP-Lesotho Country Director; Zena Stein, M.B., B.Ch., HIV Center Co-Director Emerita; Louise Kuhn, Ph.D., Professor of Epidemiology at the Mailman School; Ian McKeague, Ph.D., Professor of Biostatistics at the Mailman School; and Sally Blower, Ph.D., Director of the Biomedical Modeling Center at the David Geffen School of Medicine at the University of California at Los Angeles.

Before his untimely death last June, Alan Berkman, M.D. served as a critical bridge between ICAP and the HIV Center and played an important role in the development of the EPIC Study.