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Background: Small incentives could improve engagement in HIV care. We evaluated the short-term and longer-term effects of financial incentives for visit attendance on viral suppression among adults initiating antiretroviral therapy (ART) in Tanzania., Methods: In a type 1 hybrid effectiveness-implementation study, we randomised (1:1) 32 primary care HIV clinics in four Tanzanian regions to usual care (control group) or the intervention (usual care plus ≤6 monthly incentives [22 500 Tanzanian Shillings, about US$10, each], conditional on visit attendance). Adults (aged ≥18 years) initiating ART (<30 days) who owned a mobile phone and had no plans to transfer to another facility were eligible. The primary outcome was retention on ART with viral suppression (<1000 copies per mL) at 12 months. Secondary outcomes included retention on ART with viral suppression at 6 months and viral suppression at 6 months and 12 months using a lower threshold (<50 copies per mL). Intent-to-treat analysis and a cluster-based permutation test were used to evaluate the effect of financial incentives on outcomes. This trial is registered with ClinicalTrials.gov, NCT04201353, and is completed., Findings: Between May 28, 2021, and March 8, 2022, 1990 participants (805 male and 1185 female) were enrolled in the study. 1059 participants were assigned to the intervention group and 931 participants were assigned to the control group. Overall, 1536 (88%) participants at 6 months and 1575 (83%) at 12 months were on ART with viral suppression. At 12 months, 6 months after the intervention ended, 866 (85%) participants in the intervention group compared with 709 (81%) in the control group had viral loads less than 1000 copies per mL (adjusted risk difference [aRD] 4·4 percentage points, 95% CI -1·4 to 10·1, permutation test p=0·35). At 6 months, 858 participants (90%) in the intervention group were on ART with viral loads less than 1000 copies per mL compared with 678 (86%) in the control group (aRD 5·1 percentage points, 95% CI 1·1 to 9·1, permutation test p=0·06). Effects were larger at 6 months and 12 months with the lower threshold for viral suppression, and there was significant effect heterogeneity by region. Adverse events included 106 deaths (56 in the control group and 50 in the intervention group), none related to study participation., Interpretation: Short-term incentives for visit attendance had modest, short term benefits on viral suppression and did not harm retention or viral suppression after discontinuation. These findings suggest the need to understand subgroups who would most benefit from incentives to support HIV care., Funding: National Institute of Mental Health., Translation: For the Swahili translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Financial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania., Methods: In a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556., Findings: Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation., Interpretation: Small financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care., Funding: National Institute of Mental Health at the US National Institutes of Health., (Copyright © 2020 Elsevier Ltd. All rights reserved.)