Combining a prevention pill with community treatment programs
Monday 3 June 2013
Despite rapid advances in HIV treatment, prevention remains a challenge and goal in all parts of the world.
UC’s California HIV/AIDS Research Program (CHRP) has awarded grants totaling nearly $18 million to three teams of investigators to test a potential HIV prevention pill among high-risk HIV-uninfected people in California.
The studies also will examine new strategies, known as “TLC+" (testing and linkages to care, plus treatment), to engage and retain HIV-infected people in care and treatment.
“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."
Previous international research has shown PrEP (pre-exposure prophylaxis with anti-retroviral drugs) to be very effective in preventing HIV infections in high risk populations, but only when taken as prescribed in addition to ongoing risk-reduction counseling, said Lemp.
In addition, Lemp said, 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.
In addition to the project designed for high-risk young MSM (men who have sex with men) of color in Oakland and other East Bay cities (see feature story), two Southern California research teams will offer the prevention pill to high-risk uninfected MSM and to transgender women (male-to-female transgendered people) in Los Angeles, San Diego and Long Beach over the next three years.
It is the largest PrEP/TLC+ demonstration project initiative in the U.S. and one of the first to test the new strategies in Southern California communities.
The CHRP-funded studies in California are led by:
Division of HIV and STD Programs at the Los Angeles County Department of Public Health in collaboration with UCLA, the Los Angeles Gay and Lesbian Center, AIDS Project Los Angeles and the OASIS Clinic at Charles Drew University
The L.A. 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. In addition to offering the HIV prevention pill to about 300 eligible HIV-uninfected persons, the project includes a social network testing intervention among high-risk MSM (about 750 participants), with linkage to care for newly diagnosed HIV-positive people. The group also will test strategies to re-engage out-of-care HIV-infected people using social networks, a peer navigation program and an intensive case management strategy (about 1,200 participants in this component).
University of California, San Diego in collaboration with the UCSD Antiviral Research Center and Owen Clinic; the L.A. 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 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 PrEP, into a randomized study that evaluates whether a text messaging-based adherence intervention can improve their adherence to the medication. The study will follow participants for safety, feasibility, adherence, risk behavior and HIV seroconversion over a period averaging about two years.
The group also will 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 people 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.
The East Bay AIDS Center at Alta Bates Summit Medical Center in Oakland and Berkeley in collaboration with the Center for AIDS Prevention Studies at UCSF. 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 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+.