The Epidemic Interventions Demonstration Initiative
In April 2012, the California HIV/AIDS Research Program (CHRP) of the University of California awarded grants totaling $11.8 million to three collaborative teams of investigators to test a potential HIV prevention medication among high-risk HIV-uninfected persons in several communities throughout California. The studies also will examine new strategies to engage and retain HIV-infected persons in care and treatment. Both of these strategies are expected to help curb the HIV epidemic in California.
Two of the collaborative teams of investigators will offer PrEP (pre-exposure prophylaxis with antiretroviral drugs) to high-risk uninfected men who have sex with men (MSM) and to transgender women (male to female transgendered persons) located in Los Angeles, San Diego, and Long Beach over the next four years. These investigators also will assess the implementation of TLC+ (testing and linkage to care plus treatment), a strategy to locate, engage, and retain HIV-infected persons in care and start them on life-saving treatment for their HIV infection
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 located in Oakland, Richmond, Berkeley, and other East Bay Area locations.
PrEP involves the provision of antiretroviral drugs and risk reduction counseling to high risk uninfected persons to prevent future HIV infection among those who potentially may be exposed to the virus. Previous international research trials have shown that PrEP has been 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. Recent studies have suggested that the 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. In addition, other studies have suggested that identification and rapid institution of antiretroviral therapy for people infected with HIV 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.
This will be the largest PrEP/TLC+ demonstration project initiative in the U.S., and will be the first to test PrEP in several communities throughout California. In these demonstration projects in California, 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) based PrEP 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 product (brand name Truvada®) to support these studies. The studies will adhere to safety and implementation guidelines issued by the Centers for Disease Control and Prevention.
The three grantee consortiums for this initiative include:
- The Division of HIV and STD Programs at the Los Angeles County Department of Public Health, (Co-Lead Project Investigator, Amy Wohl) in collaboration with the University of California, Los Angeles (Co-Lead Project Investigator, Dr. Raphael Landovitz), the Los Angeles Gay and Lesbian Center, AIDS Project Los Angeles, and the OASIS Clinic at Charles Drew University. 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 LAC PATH PrEP demonstration project plans to enroll 375 high risk MSM and transgender women, who will be delivered a customized prevention package that may include PrEP. The group expects that 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 monitoring period. The LAC PATH TLC+ strategy plans to implement a protocol driven social network testing intervention among high risk MSM (about 750 participants), with linkage to care for newly diagnosed HIV+ persons. The group also will test strategies to re-engage out of care HIV+ persons utilizing social networks, a peer navigation program, and an intensive case management strategy (about 1,200 participants in the linkage and retention components).
Abstract for Wohl and Landovitz study
- 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. The California Collaborative Treatment Group (CCTG) consortium will conduct extensive HIV screening among populations in selected locations and clinics 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 the participants' ability to maintain high levels of adherence to the PrEP medication. The study will carefully follow participants for safety, feasibility, adherence, risk behavior and HIV seroconversion over a minimum 48-week monitoring period (median 23 months). 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 approximately 1,500 participants.
Abstract for Haubrich study
- 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 the University of California, San Francisco. 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 a pilot study of self-testing for HIV, in the context of an innovative sexual health services program. The East Bay consortium will offer PrEP to a small number (about 20) of HIV negative young MSM of color served at a clinic in downtown Oakland. The investigators will assess models 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+.
Abstract for Burack study
Resources for PrEP and TLC+:
- CHRP's 2011 Call for Applications for Epidemic Interventions Initiative (pdf)
- AVAC: Global Advocacy for HIV Prevention PrEP Information
- Centers for Disease Control and Prevention General Information on PrEP
- Centers for Disease Control and Prevention Interim PrEP Guidance
Considering TLC+ In California: Proceedings of a Think Tank on HIV Testing, Linkage to Care, Plus Treatment
On May 18, 2010, the California HIV/AIDS Research Program and the California Coalition of Local AIDS Directors co-sponsored a statewide Think Tank called Considering TLC+ in California. The purpose of the Think Tank was to begin to discuss implementation of TLC+ in California and to identify the key issues that need to be addressed in order to move forward. Sixty-four planners, policymakers, treatment and care providers attended the meeting.