Public health experts encourage everyone between the ages of 13 and 64 to be HIV tested. Researchers at the University of Miami Miller School of Medicine and the San Francisco Department of Public Health will determine whether receiving a rapid HIV test and counseling offers healthier outcomes than rapid testing alone, with a $12.3 million grant awarded through the American Recovery and Reinvestment Act. The grant is being funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
Currently, there is insufficient scientific evidence for comparisons. This Recovery Act-funded grant will provide the scientific evidence needed to guide decisions on the benefit of prevention counseling for those who test negative. This is in keeping with the Institute of Medicine's recommendation that determining the role of counseling with HIV testing is a high priority of comparative effectiveness research.
This year, randomized multi-center controlled trials will enroll 5,000 patients at high risk for HIV infection in nine sexually transmitted disease clinics in the United States. The sample size is large enough to allow meaningful subgroup analyses, including racial/ethnic groups, age groups, sexual orientation, gender, and substance abusers.
The study will evaluate the effect of routine counseling at screening on two primary outcomes: the incidence of sexually transmitted infections and acceptance of HIV testing. Researchers will also measure reduction of risky sexual behaviors and substance use during sex after a six month period, and cost-effectiveness of counseling and testing.
"This is a good example of how Recovery Act funding will not only advance knowledge in a high priority area of public health, but also provide jobs to researchers," said NIH Director Dr. Francis Collins. "We need to know if counseling linked to testing will have an impact on reduction of risky behaviors and the diseases linked to those behaviors for persons who test HIV-negative."
"NIH research previously showed the value of routine HIV screening in patients with or without elevated risk factors," noted NIDA Director Dr. Nora Volkow. "Now, we will leverage the infrastructure already in place through our Clinical Trials Network to address the issue of whether to provide counseling as part of that screening."
"We are pleased to be a part of such an important public health investigation," said Dr. Lisa Metsch, who will lead the scientific team at the University of Miami Miller School of Medicine along with Dr. Grant Colfax at the San Francisco Department of Public Health. "Our work will help advance the public health debate about whether to offer counseling for all patients undergoing HIV screening in health care settings."
Dr. Colfax, who oversees public HIV testing programs for San Francisco, added, "Historically, counseling has been a major component to the testing process. The question is, in this day and age, is there still some benefit to counseling; if so, for whom, and at what cost? The results of this study will help us to target our public health resources more efficiently and effectively."
The study meets the goals of the Recovery Act in providing economic benefits by creating 47 new positions and retaining 52 positions at public health clinics, universities, and research centers in multiple states, including many of those hit hardest by the recession.
The nine study sites, affiliated with the NIDA Drug Abuse Treatment Clinical Trials Network, are located in Columbia, S.C..; Jacksonville, Fla.; Los Angeles; Miami; San Francisco; Pittsburgh; Portland, Ore.; Seattle and Washington. The cost effectiveness analysis will be done by scientists at Weill Cornell Medical College in New York City. Data management support will be provided by the Duke Clinical Research Institute, Durham, N.C. Clinical coordination support will be provided by EMMES Corp., Bethesda, Md.
NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) is a multi-site research project of behavioral, pharmacological, and integrated treatment interventions to determine effectiveness across a broad range of community-based treatment settings and diversified patient populations. The CTN provides a foundation for conducting research with the primary goal of bridging the gap between the science of drug treatment and its practice through the study of scientifically based interventions in real world settings.
For information on the NIH's American Recovery and Reinvestment Act funding, visit http://grants.nih.gov/recovery. To track the progress of HHS activities funded through the recovery act, visit www.hhs.gov/recovery. To track all federal funds provided through the recovery act, visit https://obamawhitehouse.archives.gov/administration/eop/ostp/library/compliance/recoveryact