ALERT: Active Linkage, Engagement, and Retention to Treatment
ALERT: ACTIVE LINKAGE, ENGAGEMENT,AND RETENTION TO TREATMENTDecember 20, 2012Eric Daar MDKatya Calvo MDLos Angeles Biomedical Research Institute at Harbor-ULCA Medical CenterDeborah Collins, PA-CLong Beach Department of Health and Human ServicesEritrea KeletaCERP
BACKGROUND “Test and Treat” strategy has been proposed as a new tacticto fight HIV Prevention strategies also now include medicalinterventions: pre-exposure prophylaxis (PrEP) Success of both strategies depend on adequate engagementfrom the patient who must progress through multiple stepsin the healthcare system with multiple opportunities for theindividual to be lost to care Methods to improve linkage, engagement and retention ofHIV-infected new to care and high risk HIV-uninfectedpersons to PrEP need to be studied Community awareness of access to HIV care as well asaccess to PrEP clinic sites are variable
RESEARCH QUESTION1. How effective is the use of an ALERT specialist inlinking new HIV-infected persons and high risk HIV-uninfected persons from testing sites to care?2. How effective is a clinic-based ALERT specialist onimproving retention in HIV care and maintenanceof antiretroviral therapy?3. Does the use of text-message based adherenceintervention improve retention and adherence toPrEP?
METHODSCERP: Engage with community to facilitate link with Long BeachHealth Department and LaBiomed. Assist in setting up the infrastructure for linking identified patientsinto care by engaging the community in the study and providingeducational programs so that people are aware of the issuessurrounding HIV treatment and PrEP Documentation of meeting sessions with community groups Development of refusal questionnaireLinkage: Direct hand off of the interested subject with the HIVsite or PrEP siteHIV-infected: Subjects will be randomized (1:1) to either ALERT armof the standard of care. The ALERT arm will include aggressiveengagement efforts by the ALERT specialist, to includeeducational interventionsHIV-uninfected: Subjects will be given TDF+FTC fixed dosecombination and randomized (1:1) to either text messaging orstandard of care
COMMUNITY INVOLVEMENT OUTCOMES Increased community awareness of treatment of HIVand PrEP Knowledge exchange with various groups Community based organizations Long Beach Health Department LaBiomed Establish links with community groups that have insightsinto the local needs as well as potential interest andobstacles to participation Gay and Lesbian Center Bienestar World AIDS day Other HIV care sites: CARE clinic
ALERT STUDY OUTCOMESLinkage Measure the effectiveness of the linkage program Proportion of individuals who will successfully be linked to HIVcare/PrEP care within 60 days of enrollment Measure acceptance of the linkage program Refusal surveyHIV-infected Time to “lost to follow up” defined as the time from studyentry to no visit with a prescribing HIV provider in the last180 days Time to initiation of antiretroviralsHIV-uninfected Composite endpoint of remaining on PrEP and havingadherence >90% over 48 weeks of follow up.
CERP AIMS ADDRESSED Specific Aim 1: Promote and sustain bidirectional knowledge sharingbetween community and academia. Specific Aim 2: Strengthen community infrastructure for sustainablepartnered research. Specific Aim 3: Drive innovation in community engagement thataccelerates the volume and impact of partnered research in diversecommunities. Specific Aim 4: Build health services research (HSR) methods intopartnerships to accelerate design, production, and wide adoption ofevidence-based practice and behavior. Specific Aim 5: Establish a governance and operations infrastructurethat strengthens existing partnerships and builds new bridgesbetween community and academia for research
TIMELINEProject Aims Timeline in MonthsOct ‘12-Dec‘12Jan’13-March’13April’13-Dec’14Jan’15-Oct’15Establish relationship with Long Beach DOHIdentify and engage community-basedorganizations whose population would benefitfrom ALERT studyIRB submissionContinued participation in community-basedorganizations through providing lectures atmeetings, documenting feedback, organizingeventsALERT study enrollmentFacilitate the linkage of new HIV-infected toHarbor-UCLA, and those uninfected but at highrisk to one of the two PrEP clinicsALERT study follow-upData analysis
ADDED VALUE FROM CTSI FUNDING Personnel to engage and establish link withcommunity-based organization that provide servicesto HIV-infected and HIV-uninfected persons at high risk Help in building infrastructure where futurecommunity-based research can occur Encourage continued dialogue from community toresearch facilities Educate community regarding HIV care and treatmentas well as start dialogue regarding PrEP Facilitate linkage of HIV-infected persons to care Facilitate linkage of HIV-uninfected persons at highrisk to PrEP
NEXT STEPS Initial meetings with community-basedorganizations have been concluded Set up meetings with specific support-groupswithin community-based organizations topresent study Participate in ongoing activities at community-based organizations Continue weekly meetings at Long BeachHealth Department