CC BY-NC-ND licenseKufa, T.Fielding, K. L.Hippner, P.Kielmann, KarinaVassall, A.Churchyard, G. J.Grant, A. D.Charalambous, S.2019-11-042019-11-042018-07-25Kufa, T., Fielding, K.L., Hippner, P., Kielmann, K., Vassall, A., Churchyard, G.J., Grant, A.D. and Charalambous, S. (2018) ‘An intervention to optimise the delivery of integrated tuberculosis and HIV services at primary care clinics: results of the MERGE cluster randomised trial’, Contemporary Clinical Trials, 72, pp. 43–52. Available at: https://doi.org/10.1016/j.cct.2018.07.013.1551-7144https://eresearch.qmu.ac.uk/handle/20.500.12289/10171https://doi.org/10.1016/j.cct.2018.07.013Kielmann, Karina - ORCID 0000-0001-5519-1658 https://orcid.org/0000-0001-5519-1658Objectives: To evaluate the effect of an intervention to optimize TB/HIV integration on patient outcomes.Methods: Cluster randomised control trial at 18 primary care clinics in South Africa. The intervention was placement of a nurse (TB/HIV integration officer) to facilitate provision of integrated TB/HIV services, and a lay health worker (TB screening officer) to facilitate TB screening for 24 months. Primary outcomes were i) incidence of hospitalisation/death among individuals newly diagnosed with HIV, ii) incidence of hospitalisation/ death among individuals newly diagnosed with TB and iii) proportion of HIV-positive individuals newly diagnosed with TB who were retained in HIV care 12 months after enrolment.Results: Of 3328 individuals enrolled, 3024 were in the HIV cohort, 731 in TB cohort and 427 in TB-HIV cohort. For the HIV cohort, the hospitalisation/death rate was 12.5 per 100 person-years (py) (182/1459py) in the intervention arm vs. 10.4/100py (147/1408 py) in the control arms respectively (Relative Risk (RR) 1.17 [95% CI 0.92–1.49]).For the TB cohort, hospitalisation/ death rate was 17.1/100 py (67/ 392py) vs. 11.1 /100py (32/ 289py) in intervention and control arms respectively (RR 1.37 [95% CI 0.78–2.43]). For the TB-HIV cohort, retention in care at 12 months was 63.0% (213/338) and 55.9% (143/256) in intervention and control arms (RR 1.11 [95% 0.89–1.38]).Conclusions: The intervention as implemented failed to improve patient outcomes beyond levels at control clinics. Effective strategies are needed to achieve better TB/HIV service integration and improve TB and HIV outcomes in primary care clinics.Trial registration: South African Register of Clinical Trials (registration number DOH-27-1011-3846).43-52en© 2018 The Authorshttp://creativecommons.org/licenses/by-nc-nd/4.0/TuberculosisHIVIntegrationCluster Randomised TrialArticle