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    IMPACT study on intervening with a manualised package to achieve treatment adherence in people with tuberculosis: Protocol paper for a mixed-methods study, including a pilot randomised controlled trial
    (BMJ, 2019-12-17) Stagg, Helen R.; Abubakar, Ibrahim; Campbell, Colin N. J.; Copas, Andrew; Darvell, Marcia; Horne, Robert; Kielmann, Karina; Kunst, Heinke; Mandelbaum, Mike; Pickett, Elisha; Story, Alistair; Vidal, Nicole L.; Wurie, Fatima; Lipman, Marc
    Introduction Compared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB). TB is curable, although treatment is for at least 6 months and longer when disease is drug resistant. If patients miss too many doses (non-adherence), they may transmit infection for longer and the infecting bacteria may develop resistance to the standard drugs used for treatment. Non-adherence may therefore risk both their health and that of others. Within England, certain population groups are thought to be at higher risk of non-adherence, but the factors contributing to this have been insufficiently determined, as have the best interventions to promote adherence. The objective of this study was to develop a manualised package of interventions for use as part of routine care within National Health Services to address the social and cultural factors that lead to poor adherence to treatment for TB disease.
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    A cluster randomised trial to evaluate the effect of optimising TB/HIV integration on patient level outcomes: The merge- trial protocol
    (Elsevier, 2014-10) Kufa, T.; Hippner, P.; Charalambous, S.; Kielmann, Karina; Vassall, A.; Churchyard, G.; Grant, Alison D.; Fielding, K.
    Introduction We describe the design of the MERGE trial, a cluster randomised trial, to evaluate the effect of an intervention to optimise TB/HIV service integration on mortality, morbidity and retention in care among newly-diagnosed HIV-positive patients and newly-diagnosed TB patients. Design Eighteen primary care clinics were randomised to either intervention or standard of care arms. The intervention comprised activities designed to optimise TB and HIV service integration and supported by two new staff cadres-a TB/HIV integration officer and a TB screening officer-for 24 months. A process evaluation to understand how the intervention was perceived and implemented at the clinics was conducted as part of the trial. Newly-diagnosed HIV-positive patients and newly-diagnosed TB patients were enrolled into the study and followed up through telephonic interviews and case note abstractions at six monthly intervals for up to 18 months in order to measure outcomes. The primary outcomes were incidence of hospitalisations or death among newly diagnosed TB patients, incidence of hospitalisation or death among newly diagnosed HIV-positive patients and retention in care among HIV-positive TB patients. Secondary outcomes of the study included measures of cost-effectiveness. Discussion Methodological challenges of the trial such as implementation of a complex multi-faceted health systems intervention, the measurement of integration at baseline and at the end of the study and an evolving standard of care with respect to TB and HIV are discussed. The trial will contribute to understanding whether TB/HIV service integration affects patient outcomes.