Evaluation of 'Real-Life' Usage of HIV Pre-Exposure Prophylaxis
Study in Progress by: Michael Kolber, Ph.D, MD
Comprehensive AIDS Program University of Miami; Adult HIV Services, Infectious Diseases, University of Miami Miller School of Medicine
In 2010, it was demonstrated, in a large randomized trial, that HIV-negative MSM (men who have sex with men) have a dramatically reduced (44%) of HIV acquisition when they take the combination antiretroviral Truvada (tenofovir/emtricitabine) daily compared to those that did not. Such a study begged the question if such a treatment paradigm was rolled out in high-risk communities, would this change the fundamental course of HIV infection, and would it ultimately result in an eventual cost savings when viewed over time. Although this continues to be a controversial topic, it is important to address the important question of whether, in a "real-life" situation, individuals who are on this pre-exposure prophylaxis (PrEP) actually take the medication as prescribed. To address this fundamental question the National Institutes of Health alongside the University of Miami Infectious Diseases group and the San Francisco Department of Public Health plan to perform this study this summer.
In the Miami/San Francisco PrEP Demonstration Project, MSM and transgender females (TGF) that are at high risk for acquiring HIV infection will be offered HIV PrEP. Services will be offered at the Miami-Dade County Health Department. Study participants will receive daily Truvada. A number of questionnaires will be given throughout the study to evaluate transmission risk-taking behaviors, changes in transmission risk-taking behaviors over time, and assess PrEP adherence over 48 weeks of study. Two hundred individuals will be recruited at the Miami site and 300 in San Francisco.
It is expected that the data obtained will inform the question regarding whether individuals who are given PrEP take it as prescribed, as well as whether any possible medication side effects mitigate this prevention option.
Study in Progress by: Tanya Schreibman, M.D.
Community AIDS Network, Sarasota, Florida
Current HIV guidelines recommend treatment with an NRTI(s)+NNRTI or PI/r. In spite of great advances in HIV treatment, these regimens are often accompanied by serious long and short-term side effects. The "No Nukes" study will evaluate the use of a regimen that utilizes an integrase inhibitor, raltegravir (RAL) in combination with the PI, atazanavir (ATV) unboosted (without ritonavir) compared to standard NRTI/PI/r based regimens. The availability of RAL provides an opportunity to examine alternative ARV strategies that may be equally efficacious and less toxic than those currently recommended in HIV treatment guidelines. Such combinations could include RAL+ATV regimen without a concomitant N(t)RTI(s) based backbone and/or the inclusion of RTV. Before a RAL based strategy that does not include N(t)RTIs or RTV can be compared to other ARV class strategies for long-term efficacy outcomes, preliminary data on a RAL+ATV based regimen is needed. This pilot study will provide data on the safety and efficacy of the combination of RAL 400mg BID + ATV 300 mg BID in ARV-experienced subjects that have a suppressed HIV viral load on a RTV boosted PI based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg BID. The study will run for 48 weeks, and involve the participation of 60 individuals. This project is collaboration between Yale University and the Community AIDS Network, Sarasota, Florida.
Cognitive Behavioral HIV Risk Reduction in Those Receiving Psychiatric Treatment: A Clinical Trial
Abstract by: RM Malow, RC McMahon, J Devieux, R Risenberg, A Frankel, V Bryant, B Lerner, MJ Miguez
Florida International University
Among severely mentally ill (SMI) substance abusers, HIV rates are elevated and HIV risk reduction interventions have been shown to be less effective. An enhanced cognitive behavioral HIV risk reduction intervention for SMI was compared to a health promotion condition in 222 psychiatric outpatients at 6 months post intervention. Compared to females, males in the risk reduction intervention improved on intention to practice safer sex and in condom use skills and in unprotected vaginal sex. However they did not differ in HIV knowledge, perceived susceptibility, anxiety, condom attitudes, safer sex self-efficacy, unprotected vaginal sex acts, or sex partners. Across intervention groups, there were improvements in all areas except self-efficacy and number of partners. Risk reduction among SMI may be facilitated by increasing awareness of health related behaviors and HIV-targeted content. However, meaningful changes in critical risk reduction skills and intentions may require a more focused intervention and may vary by gender.
Racial Disparities in AIDS Survival, Florida, 1993-2007
Abstract by: Trepka, MJ; Niyonsenga T; Maddox L; Lieb S; Lutfi K; Pavlova-McCalla E.
Florida International University, Florida Consortium for HIV/AIDS Research, and Florida Department of Health
Background: This study describes racial/ethnic survival patterns among Florida residents reported with an acquired immunodeficiency syndrome (AIDS) diagnosis to the Florida Human Immunodeficiency Virus/AIDS Reporting System from 1993 to 2004.
Methods: Vital status was ascertained by linkage with Florida Vital Records, the Social Security Death Master File, and the National Death Index. We calculated adjusted Cox proportional hazard ratios (HR) for racial/ethnic groups, controlling for age, sex, mode of transmission, poverty, and birth place for the entire period and stratified in two-year intervals by time of AIDS diagnosis.
Results: Of the 79,479 people in the cohort, 34,504 (43.4%) died between 1993 and 2007. For the entire period shorter survival times were associated with residence in areas with a high percentage of people living in poverty (HR comparing quartile living in the most to quartile living in the least impoverished areas: 1.33 [95% CI 1.28-1.38]); being an injection drug user (HR compared with being a man who has sex with men: 1.25 [95% CI 1.21-1.30)]; being US-born (HR 1.28 [95% CI 1.24-1.32]); being male (HR 1.06 [95% CI 1.03-1.09)]; and being of African-American race/ethnicity (HR compared with non-Hispanic white 1.15 [95% 1.11-1.18]). There was no difference in survival between Hispanics and non-Hispanic whites. Racial disparities peaked in 1996-1998 and thereafter declined to some extent. Socioeconomic disparities did not decline.
Conclusions: African Americans and people living in high-poverty areas were at a higher risk for death throughout the study period. Racial/ethnic disparities diminished somewhat during the era of highly active antiretroviral therapy.
Use Of Digital Technology for Health Interventions in Public Health HIV/ STD Clinics
Abstract by: Robert L. Cook, MD, MPH, Xingdi Hu, MS, Virginia Dodd, PhD; James Oliverio, MFA
University of Florida, Gainesville
Information and communication technologies such as internet, email, cell phone, and even video games, may offer compelling avenues to deliver health interventions to persons with HIV infection or those at increased risk. Examples of possible uses include medication adherence reminders, linkage/reminders to clinic services, or interventions to address substance use behavior. However, little is known about access to these technologies among persons seen in public health clinic settings. In 2009, we surveyed consecutive persons attending two STD clinics based in county health departments in North Central Florida. Our goals were to determine the types of technology used and the potential acceptance of digital technology interventions within the clinic setting.
Of 396 persons attending STD clinics, the mean age was 25 years, 66% were female, 60% were African American, 57% had high school degree or less, 59% reported being unemployed, and half were uninsured. Approximately one third (32%) of participants met criteria for hazardous alcohol consumption. Almost all respondents (93%) reported having internet access at least monthly, 80% reported having an email account, and 53% reported checking their email account at least every day. Almost nine in ten participants (87%) reported currently owning a cell phone, and 94% reported using any cell phone applications. More than two thirds (69%) of respondents reported enjoying playing a video game. Although persons were generally open to using a computer-based intervention in the clinic setting, fewer than half would want to receive actual clinic results on their cell phone. In adjusted analyses, higher education and younger age were strongly related to the use of cell phone, internet and email use, while male gender was associated with video game playing.
We concluded that information and digital technology use is exceptionally common among persons attending STD clinics, and that nearly every person attending these public health clinics had a cell phone. The persons seen in public health department HIV clinics are likely to have similar characteristics, and therefore, intervention strategies that use cell phones or other digital devices may be acceptable and useful in this population. Our research group is considering a follow-up study to explore possible uses for digital technologies within HIV clinic settings across Florida. Persons interested in potential collaboration on this project should contact Dr. Cook at firstname.lastname@example.org.
(These data will be presented at the upcoming Academy Health Annual Research Conference in Orlando by Xingdi Hu, a graduate student in epidemiology at the University of Florida.)