Background Concerning gaps in the HIV care continuum compromise individual and population health. We evaluated a combination intervention strategy (CIS) targeting prevalent barriers to timely linkage and sustained retention in HIV care in Mozambique. Methods and findings In this cluster-randomized trial, 10 primary health facilities in the city of Maputo and Inhambane Province were randomly assigned to provide the CIS or the standard of care (SOC). The CIS included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS) health messages and appointment reminders. A pre–post intervention 2-sample design was nested within the CIS arm to assess the effectiveness of CIS+, an enhanced version of the CIS that additionally included conditional non-cash financial incentives for linkage and retention. The primary outcome was a combined outcome of linkage to care within 1 month and retention at 12 months after diagnosis. From April 22, 2013, to June 30, 2015, we enrolled 2,004 out of 5,327 adults ≥18 years of age diagnosed with HIV in the voluntary counseling and testing clinics of participating health facilities: 744 (37%) in the CIS group, 493 (25%) in the CIS+ group, and 767 (38%) in the SOC group. Fifty-seven percent of the CIS group achieved the primary outcome versus 35% in the SOC group (relative risk [RR]CIS vs SOC = 1.58, 95% CI 1.05–2.39). Eighty-nine percent of the CIS group linked to care on the day of diagnosis versus 16% of the SOC group (RRCIS vs SOC = 9.13, 95% CI 1.65–50.40). There was no significant benefit of adding financial incentives to the CIS in terms of the combined outcome (55% of the CIS+ group achieved the primary outcome, RRCIS+ vs CIS = 0.96, 95% CI 0.81–1.16). Key limitations include the use of existing medical records to assess outcomes, the inability to isolate the effect of each component of the CIS, non-concurrent enrollment of the CIS+ group, and exclusion of many patients newly diagnosed with HIV. Conclusions The CIS showed promise for making much needed gains in the HIV care continuum in our study, particularly in the critical first step of timely linkage to care following diagnosis. Trial registration ClinicalTrials.gov NCT01930084, In a cluster-randomized trial done in Mozambique, Batya Elul and colleagues study a combined intervention for linkage to and retention of people with HIV in care., Author summary Why was this study done? In sub-Saharan Africa, HIV testing, care, and treatment programs have been widely scaled up over the past decade, but suboptimal outcomes across the HIV care continuum—particularly with regards to timely linkage to and sustained retention in care—compromise their effectiveness. Patients experience multiple barriers to linkage to and retention in HIV care including health system barriers, structural barriers, and behavioral barriers, yet prior studies have largely evaluated individual interventions targeting a single barrier to care. Our study was designed specifically to examine the effectiveness of a combination intervention strategy (CIS) composed of several scalable evidence-based interventions targeting the multiple and prevalent health system, structural and behavioral barriers that patients face across the HIV continuum. What did the researchers do and find? We randomly assigned 10 primary health facilities in the city of Maputo and Inhambane Province in Mozambique to provide the standard of care (SOC) or the CIS, which included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS) health messages and appointment reminders. A pre–post intervention 2-sample design was nested within the intervention arm to assess the effectiveness of CIS+, an enhanced version of the CIS that additionally included conditional non-cash financial incentives for linkage and retention. We enrolled 2,004 adults diagnosed with HIV in the voluntary counseling and testing clinics of participating health facilities, and compared the proportion who achieved a combined outcome of linkage to HIV care within 1 month of diagnosis and retention in care at 12 months across the 3 study groups. We found an increased likelihood of achieving the combined outcome in the CIS group compared to the SOC group, driven primarily by very large increases in same-day linkage, but no difference between the CIS+ and CIS groups. What do these findings mean? The CIS may help improve outcomes across the HIV care continuum in high-burden settings, particularly in the critical first step of timely linkage to care following diagnosis. Further research is needed to understand whether financial incentives can be optimized in this setting, given their effectiveness in enhancing other health outcomes.