Linkage Case Management and Posthospitalization Outcomes in People With HIV: The Daraja Randomized Clinical Trial.

Key Points: Question: Can a linkage case management intervention decrease mortality among people with HIV in Tanzania during the first year after hospital discharge? Finding: In this randomized clinical trial that involved 500 hospitalized people with HIV, a linkage case management intervention did not reduce 12-month mortality (17.2% with intervention vs 16.8% with standard care; hazard ratio, 1.01; 95% CI, 0.66-1.55; P =.96). Meaning: Among hospitalized people with HIV, linkage case management did not reduce 12-month mortality. Importance: Despite the widespread availability of antiretroviral therapy (ART), people with HIV still experience high mortality after hospital admission. Objective: To determine whether a linkage case management intervention (named "Daraja" ["bridge" in Kiswahili]) that was designed to address barriers to HIV care engagement could improve posthospital outcomes. Design, Setting, and Participants: Single-blind, individually randomized clinical trial to evaluate the effectiveness of the Daraja intervention. The study was conducted in 20 hospitals in Northwestern Tanzania. Five hundred people with HIV who were either not treated (ART-naive) or had discontinued ART and were hospitalized for any reason were enrolled between March 2019 and February 2022. Participants were randomly assigned 1:1 to receive either the Daraja intervention or enhanced standard care and were followed up for 12 months through March 2023. Intervention: The Daraja intervention group (n = 250) received up to 5 sessions conducted by a social worker at the hospital, in the home, and in the HIV clinic over a 3-month period. The enhanced standard care group (n = 250) received predischarge HIV counseling and assistance in scheduling an HIV clinic appointment. Main Outcomes and Measures: The primary outcome was all-cause mortality at 12 months after enrollment. Secondary outcomes related to HIV clinic attendance, ART use, and viral load suppression were extracted from HIV medical records. Antiretroviral therapy adherence was self-reported and pharmacy records confirmed perfect adherence. Results: The mean age was 37 (SD, 12) years, 76.8% were female, 35.0% had CD4 cell counts of less than 100/μL, and 80.4% were ART-naive. Intervention fidelity and uptake were high. A total of 85 participants (17.0%) died (43 in the intervention group; 42 in the enhanced standard care group); mortality did not differ by trial group (17.2% with intervention vs 16.8% with standard care; hazard ratio [HR], 1.01; 95% CI, 0.66-1.55; P =.96). The intervention, compared with enhanced standard care, reduced time to HIV clinic linkage (HR, 1.50; 95% CI, 1.24-1.82; P <.001) and ART initiation (HR, 1.56; 95% CI, 1.28-1.89; P <.001). Intervention participants also achieved higher rates of HIV clinic retention (87.4% vs 76.3%; P =.005), ART adherence (81.1% vs 67.6%; P =.002), and HIV viral load suppression (78.6% vs 67.1%; P =.01) at 12 months. The mean cost of the Daraja intervention was about US $22 per participant including startup costs. Conclusions and Relevance: Among hospitalized people with HIV, a linkage case management intervention did not reduce 12-month mortality outcomes. These findings may help inform decisions about the potential role of linkage case management among hospitalized people with HIV. Trial Registration: ClinicalTrials.gov Identifier: NCT03858998 This randomized trial assesses whether a linkage case management intervention reduces 12-month mortality compared with enhanced standard care among people with HIV not taking antiretroviral therapy (ART) who were hospitalized for any reason. [ABSTRACT FROM AUTHOR]