Abstract
BACKGROUND: In sub-Saharan Africa (SSA), hospitalized HIV-infected patients who are discharged home have been shown to experience extremely high mortality rate. Daraja is an individual-level, time-limited, five-session case management intervention aiming to link hospitalized HIV-infected patients to outpatient HIV care upon discharge. METHODS: A randomized control trial will aim at evaluating the efficacy of Daraja intervention on reducing mortality in hospitalized HIV-infected patients upon discharge from hospital. The study will recruit 500 hospitalized HIV-infected adults who are ART naïve or defaulted for >7 days from hospitals in Mwanza region, Tanzania. Participants will be enrolled during hospitalization and a baseline assessment will be done. Participants will be randomized to receive either the standard of care HIV linkage, or the Daraja intervention a day before the expected hospital discharge date. The Daraja intervention includes five sessions delivered by a social worker over a 3-month period. All participants will complete follow-up assessment at month 12 and 24. Measures will include 1-year survival, HIV care continuum outcomes (linkage, retention, antiretroviral adherence, and viral suppression), and cost (incremental cost of the intervention and cost per life saved). Quality assurance data will be collected, and the feasibility and acceptability of the intervention will be described. Statistical analysis will assess the effectiveness of the Daraja intervention on improving survival and HIV care continuum outcomes. DISCUSSION: Hospitalized HIV-infected patients who are being discharged home have higher mortality due to poor linkage to primary HIV care. The Daraja intervention has the potential to address barriers that prevent successful transition from hospital to primary HIV care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03858998. Registered on 01 March 2019.