Background: Gaps in the HIV care continuum contribute to suboptimal individual health outcomes and increased HIV transmission. Practical interventions targeting known barriers to care are needed.
Methods: Link4Health, a cluster-randomized controlled trial, evaluated the effectiveness of a combination intervention strategy (CIS) versus standard of care (SOC) on the combined outcome of linkage to care within 1 month and retention in care at 12 months after HIV diagnosis. CIS included: point-of-care CD4 at the time of HIV+ test, accelerated antiretroviral treatment for adults with CD4< 350 cells/uL, mobile phone appointment reminders, health educational packages, and non-cash financial incentives. Ten study clusters in Swaziland, each consisting of a network of affiliated HIV clinics, were randomized to CIS versus SOC. Adults >18 years newly tested HIV+ and willing to receive HIV care at the study unit were enrolled from August 2013-November 2014 and followed for 12 months.
Results: A total of 2201 individuals were enrolled (1100 CIS arm; 1101 SOC arm). The majority were female (59%); median age was 32 years (IQR 26-40). In intention-to-treat analysis, 64% (705/1100) adults at CIS sites achieved the primary outcome versus 43% (477/1101) at SOC sites [relative risk (RR) 1.48, 95% CI 1.36-1.60, p< 0.0001], with similar result when adjusted for clustering. Participants in the CIS versus the SOC study arm had higher linkage to care within 1 month (92% versus 83%, RR 1.10, 95% CI 1.07-1.14, p< 0.0001); higher 12-month retention (65% versus 45%, RR 1.45, 95% CI 1.34-1.56, p< 0.0001); and lower death before ART initiation (1% versus 2%, RR 0.44, 95% CI 0.21-0.91, p=0.02). A higher proportion of those lost to follow-up at 12 months were pre-ART compared to ART patients. The effectiveness of the CIS intervention did not differ by age, sex, distance to clinic or clinic type.
Conclusions: A combination strategy of pragmatic evidenced-based interventions, aimed at gaps in the HIV care continuum, was associated with a 50% increase in prompt linkage to care and 12-month retention. This strategy offers promise for enhanced outcomes among HIV-infected patients and for decreased transmission to others.