1. ALERT: ACTIVE LINKAGE, ENGAGEMENT,
AND RETENTION TO TREATMENT
December 20, 2012
Eric Daar MD
Katya Calvo MD
Los Angeles Biomedical Research Institute at Harbor-ULCA Medical Center
Deborah Collins, PA-C
Long Beach Department of Health and Human Services
Eritrea Keleta
CERP

2. BACKGROUND
 “Test and Treat” strategy has been proposed as a new tactic
to fight HIV
 Prevention strategies also now include medical
interventions: pre-exposure prophylaxis (PrEP)
 Success of both strategies depend on adequate engagement
from the patient who must progress through multiple steps
in the healthcare system with multiple opportunities for the
individual to be lost to care
 Methods to improve linkage, engagement and retention of
HIV-infected new to care and high risk HIV-uninfected
persons to PrEP need to be studied
 Community awareness of access to HIV care as well as
access to PrEP clinic sites are variable

3. RESEARCH QUESTION
1. How effective is the use of an ALERT specialist in
linking new HIV-infected persons and high risk HIV-
uninfected persons from testing sites to care?
2. How effective is a clinic-based ALERT specialist on
improving retention in HIV care and maintenance
of antiretroviral therapy?
3. Does the use of text-message based adherence
intervention improve retention and adherence to
PrEP?

4. METHODS
CERP: Engage with community to facilitate link with Long Beach
Health Department and LaBiomed.
 Assist in setting up the infrastructure for linking identified patients
into care by engaging the community in the study and providing
educational programs so that people are aware of the issues
surrounding HIV treatment and PrEP
 Documentation of meeting sessions with community groups
 Development of refusal questionnaire
Linkage: Direct hand off of the interested subject with the HIV
site or PrEP site
HIV-infected: Subjects will be randomized (1:1) to either ALERT arm
of the standard of care. The ALERT arm will include aggressive
engagement efforts by the ALERT specialist, to include
educational interventions
HIV-uninfected: Subjects will be given TDF+FTC fixed dose
combination and randomized (1:1) to either text messaging or
standard of care

5. COMMUNITY INVOLVEMENT OUTCOMES
 Increased community awareness of treatment of HIV
and PrEP
 Knowledge exchange with various groups
 Community based organizations
 Long Beach Health Department
 LaBiomed
 Establish links with community groups that have insights
into the local needs as well as potential interest and
obstacles to participation
 Gay and Lesbian Center
 Bienestar
 World AIDS day
 Other HIV care sites: CARE clinic

6. ALERT STUDY OUTCOMES
Linkage
 Measure the effectiveness of the linkage program
 Proportion of individuals who will successfully be linked to HIV
care/PrEP care within 60 days of enrollment
 Measure acceptance of the linkage program
 Refusal survey
HIV-infected
 Time to “lost to follow up” defined as the time from study
entry to no visit with a prescribing HIV provider in the last
180 days
 Time to initiation of antiretrovirals
HIV-uninfected
 Composite endpoint of remaining on PrEP and having
adherence >90% over 48 weeks of follow up.

7. CERP AIMS ADDRESSED
 Specific Aim 1: Promote and sustain bidirectional knowledge sharing
between community and academia.
 Specific Aim 2: Strengthen community infrastructure for sustainable
partnered research.
 Specific Aim 3: Drive innovation in community engagement that
accelerates the volume and impact of partnered research in diverse
communities.
 Specific Aim 4: Build health services research (HSR) methods into
partnerships to accelerate design, production, and wide adoption of
evidence-based practice and behavior.
 Specific Aim 5: Establish a governance and operations infrastructure
that strengthens existing partnerships and builds new bridges
between community and academia for research

8. TIMELINE
Project Aims Timeline in Months
Oct ‘12-
Dec‘12
Jan’13-
March’13
April’13-
Dec’14
Jan’15-
Oct’15
Establish relationship with Long Beach DOH
Identify and engage community-based
organizations whose population would benefit
from ALERT study
IRB submission
Continued participation in community-based
organizations through providing lectures at
meetings, documenting feedback, organizing
events
ALERT study enrollment
Facilitate the linkage of new HIV-infected to
Harbor-UCLA, and those uninfected but at high
risk to one of the two PrEP clinics
ALERT study follow-up
Data analysis

9. ADDED VALUE FROM CTSI FUNDING
 Personnel to engage and establish link with
community-based organization that provide services
to HIV-infected and HIV-uninfected persons at high risk
 Help in building infrastructure where future
community-based research can occur
 Encourage continued dialogue from community to
research facilities
 Educate community regarding HIV care and treatment
as well as start dialogue regarding PrEP
 Facilitate linkage of HIV-infected persons to care
 Facilitate linkage of HIV-uninfected persons at high
risk to PrEP

10. NEXT STEPS
 Initial meetings with community-based
organizations have been concluded
 Set up meetings with specific support-groups
within community-based organizations to
present study
 Participate in ongoing activities at community-
based organizations
 Continue weekly meetings at Long Beach
Health Department