Epidemic Interventions Press Release

FOR IMMEDIATE RELEASE
TUESDAY, APRIL 17, 2012
Contact: Dr. George Lemp, California HIV/AIDS Research Program at UC Office of the President
(510) 987-9856 (office), (510) 541-9856 (cell)
George.lemp@ucop.edu

UC launches initiative to test an HIV prevention pill in California

The California HIV/AIDS Research Program (CHRP) of the University of California today (April 17) announced that it has awarded grants totaling $11.8 million to three teams of investigators to test a potential HIV prevention pill among high-risk HIV-uninfected persons in California.

The studies also will examine new strategies to engage and retain HIV-infected persons in care and treatment. These combined strategies are expected to help curb the HIV epidemic in California.

Two of the research teams will offer the HIV prevention pill - part of an intervention known as PrEP (pre-exposure prophylaxis with antiretroviral drugs) - to an estimated 700 high-risk uninfected men who have sex with men (MSM) and to transgender women (male to female transgendered persons) in Los Angeles, San Diego and Long Beach over the next four years. PrEP also includes the provision of risk reduction counseling and other services.

These researchers also will assess the implementation of testing and linkage to care plus treatment - known as "TLC+" - a strategy to locate, engage and retain HIV-infected persons in care and start them on life-saving treatment for HIV infection. The TLC+ intervention will include some 3,000 persons in Southern California.

A third grantee consortium will not fully implement PrEP or TLC+ at the present time, but will instead plan and pilot PrEP/TLC+ implementation strategies for young MSM of color in Oakland, Richmond, Berkeley, and other East Bay Area locations. M.

This will be the largest PrEP/TLC+ demonstration project initiative in the U.S., and the first to test PrEP in these Southern California communities. "HIV has been with us for more than 30 years, and it's time to provide some new interventions for high risk people so they have options to protect themselves and prevent further transmission," said George Lemp, Dr.P.H., director of the UC-based CHRP. "We hope this new approach can finally help to curtail the epidemic in this state," Lemp said. "These studies will provide critical information on the implementation of PrEP and TLC+ strategies in California, and will help guide state and national efforts to address the epidemic," said Lemp. "UC is pleased to support this important initiative in California, which we believe is unique in the nation," said Steven Beckwith, Ph.D., UC vice president for research and graduate studies. "We are pleased that UC resources and talent can play an important role in addressing these health care challenges as the research arm of the State," Beckwith said.

In these California demonstration projects, PrEP will be delivered as part of a comprehensive prevention package including risk reduction counseling, sexually transmitted infection screening, and other components. Daily Tenofovir/FTC (Truvada©, a tenofovir/emtricitabine two-drug combination pill manufactured and distributed by Gilead Sciences, Inc. of Foster City, CA) will be offered to eligible uninfected high-risk men who have sex with men, as well as to transgender women. Gilead Sciences will provide the drug to support these studies. The studies will adhere to safety and implementation guidelines issued by the Centers for Disease Control and Prevention.

Previous international research has shown PrEP to be very effective in preventing new HIV infections among MSM and selected other risk populations, but only when taken as prescribed in addition to ongoing risk reduction counseling, said Lemp. Recent studies have suggested that mixed results found for some populations may be due to a lack of consistent adherence to the medication, leading to suboptimal or ineffective levels of drug in the body, he noted.

In addition, other studies have suggested that identifying people infected with HIV and rapid institution of antiretroviral therapy not only improves survival of those treated, but also lowers the level of HIV virus in the community and might ultimately reduce HIV transmission rates, said Lemp.

The three grantee consortiums for this initiative include:

  • The Division of HIV and STD Programs at the Los Angeles County Department of Public Health, (Lead Project Investigator, Dr. Jennifer Sayles) in collaboration with UCLA, the Los Angeles Gay and Lesbian Center, AIDS Project Los Angeles, and the OASIS Clinic at Charles Drew University (total 4-year budget = $5,767,146). The LA County PrEP and TLC+ for HIV Prevention (PATH) Consortium will conduct extensive screening for HIV among populations in high disease burden locations in Los Angeles County. The LA County PATH PrEP demonstration project plans to enroll 375 high risk MSM and trangender women, who will receive a customized prevention package that may include PrEP. Of these, about 300 persons will receive daily Tenofovir/FTC based PrEP, and will be assessed for safety, feasibility, adherence (utilizing a real-time and full drug-level monitoring plan), risk behavior and HIV seroconversions over a 48-week period.

    The LA County PATH TLC+ strategy plans a social network testing intervention among high risk MSM (about 750 participants), with linkage to care for newly diagnosed HIV positive persons. The group also will test strategies to re-engage out of care HIV infected persons utilizing social networks, a peer navigation program and an intensive case management strategy (about 1,200 participants in this component).

    "This demonstration project provides a unique opportunity to rigorously evaluate the feasibility, acceptability and effectiveness of biomedical HIV prevention strategies that have shown efficacy for reducing HIV transmission, but have not been tested more broadly in high risk communities outside of the clinical trial setting" said lead project investigator Jennifer Sayles, MD, MPH, medical director at the Los Angeles County Department of Public Health, Division of HIV and STD Programs, and Assistant Professor at UCLA. "Operational and implementation research conducted through this grant will allow us to answer some of the critical public health questions most relevant to curbing our local epidemic," she said.


  • The University of California, San Diego (Lead Project Investigator, Dr. Richard Haubrich), in collaboration with the UCSD Antiviral Research Center and Owen Clinic, the LA County-University of Southern California Rand Schrader Clinic, the Harbor-UCLA Medical Center, the San Diego County HIV, STD, and Hepatitis Branch, and the Long Beach Health and Human Services Agency (total 4-year budget = $5,688,621). The California Collaborative Treatment Group (CCTG) consortium will conduct extensive HIV screening in San Diego, Los Angeles, and Long Beach, including a social-network based testing strategy. The CCTG plans to enroll 400 eligible high-risk MSM, who will receive daily Tenofovir/FTC based PrEP, into a randomized study that evaluates whether a text-messaging based adherence intervention can improve their adherence to the PrEP medication. The study will follow participants for safety, feasibility, adherence, risk behavior and HIV seroconversion over a period averaging about two years.

    The group will also assess the impact of Active Linkage and Engagement (ALERT) specialists who will work to ensure that people recently testing HIV positive (or who have fallen out of care) are engaged into HIV care and that eligible high-risk HIV uninfected persons are offered PrEP. The goal of the ALERT specialist is to reduce the time from HIV diagnosis to initiation of treatment. The CCTG investigations will involve some 1,500 participants.

    "There is no question that biomedical HIV prevention strategies, such as PrEP for HIV-uninfected and initiation of early antiretroviral therapy for HIV-infected people, can prevent future HIV infection", said Richard Haubrich, M.D., CCTG director and UCSD professor of medicine. "The key is to empower people to initiate and maintain strict adherence to therapy. Ultimately, we hope these efforts will result in a reduction of new HIV infections in high-risk populations and improved clinical outcome for those who are currently HIV-infected", he said.


  • The East Bay AIDS Center at Alta Bates Summit Medical Center in Oakland and Berkeley (Lead Project Investigator, Dr. Jeffrey Burack), in collaboration with the Center for AIDS Prevention Studies at UCSF (total 1-year budget = $336,730). This consortium will develop and refine innovative strategies for outreach, HIV testing, sexual health services, and linkage to care for young MSM of color in Oakland, Richmond, Berkeley and other East Bay Area locations. The group will conduct a pilot study of clinic-based social network testing and self-testing for HIV, in the context of an innovative sexual health services program. The East Bay consortium also will plan and pilot strategies to offer PrEP to high-risk HIV uninfected young MSM of color. The researchers will study model programs for engaging young HIV positive MSM of color in primary care, and will conduct focus groups and in-depth interviews to assess needs and priorities of this population, with the goal of eventually fielding a larger scale prevention program that incorporates culturally appropriate PrEP and TLC+.

    "Young MSM of color in urban California are especially vulnerable to HIV, with annual rates of new infection comparable to those in Sub-Saharan Africa," said lead project investigator Jeffrey Burack, M.D., co-medical director of the East Bay AIDS Center and associate clinical professor at UC Berkeley and UCSF. "But these very people most at risk have been woefully under-researched when it comes to prevention interventions that will actually reach them. With CHRP's support, we hope to implement and evaluate promising new interventions to stem the relentless surge of HIV through our community, potentially reducing its terrible toll on young lives and its costs to our health care system," he said.

The California HIV/AIDS Research Program (CHRP) provides state funding for cutting edge merit-reviewed HIV-related research conducted at nonprofit research institutions and community-based organizations throughout California. The program has awarded more than 2,000 research grants to more than 50 California institutions since 1983. A 2006 survey of California investigators found that more than five dollars in federal and other grant support was generated for every dollar invested by CHRP in California-based research.

For more information about the California HIV/AIDS Research Program, please visit:
http://www.californiaaidsresearch.org/