UCSD: ALERT-Active Linkage, Engagement and Retention to Reduce HIV

Background: Scientific evidence supports the role of antiretroviral (ARV) medications in the prevention of HIV infection by making the virus undetectable in blood of those that can transmit HIV and by reducing the chance of getting infected, if taken by individuals exposed to HIV. Treating HIV-infected individuals can benefit both the health of the community (by preventing new infections) and the individual. To achieve the greatest benefit for all, as many HIV-infected individuals as possible need to be engaged in medical care. The current HIV care system needs to be optimized for the transition of individuals from the diagnosis to treatment.

Results from recent prevention studies have shown that if HIV uninfected individuals, who are exposed to HIV through high-risk behaviors, are prescribed ARVs for pre-exposure prophylaxis (PrEP), they will have a reduced chance of acquiring HIV. The concept of using ARVs for prevention is new; how PrEP could be integrated into current clinical practice has not been studied. Similar to treating those with HIV infection, the individuals targeted for PrEP will need to be identified and engaged in medical care with provision of comprehensive prevention services, provision of ARVs, monitoring for safety and reinforcement of medication adherence.

Aims: There are three parts for our proposed demonstration project:

1. The first part (Test and Link) will focus on linking new HIV diagnoses and those at highest risk of acquiring HIV into care for assessment. The project will use an Active Linkage, Engagement, and Retention (ALERT) specialist and measure how many and how well the specialist connects new patients from the testing site to a healthcare provider.
2. The second part (Engagement in Care for HIV-Infected) will study how effective the ALERT specialist is to retain HIV-infected patients in care compared to current Standard of Care (SOC).
3. The third part (PrEP) will study how the ALERT specialist, using a personalized texting adherence application, helps the patient keep on their PrEP schedule compared to standard of care PrEP alone. 

Study Design: Our demonstration projects will be a collaboration of three HIV testing sites (the San Diego County HIV, STD, and Hepatitis Branch, the Long Beach Health and Human Services and LAC-USC Emergency) with three CCTG primary HIV clinics (UCSD Owen Clinic, Harbor-UCLA Medical Center and LAC-USC Rand Schrader Clinic). We will enroll 300 newly diagnosed or lost or care HIV infected people and 300 individuals at high-risk for HIV acquisition. Participants will be on study for at least 12 months at one of the three existing CCTG HIV primary care clinics to receive HIV care or PrEP, respectively.

Newly diagnosed HIV-infected individuals willing to be linked to primary care will be placed into the Engagement in Care Project and either given SoC or SoC with the ALERT intervention. The Intervention arm will include enhanced retention efforts by an ALERT specialist. HIV uninfected participants determined as having sustained “high risk” for HIV and who are willing to take PrEP will all receive a comprehensive preventive care or the same care combined the ALERT specialist using a personalized text-messaging system that reminds participants to take their medication. For all three projects, we will evaluate determinants of suboptimal engagement including demographic, substance use, mental illness, economic and psychosocial factors.