Project: Translating Research into Practice (TRIP): Evaluating and Speeding up the adoption of an evidenced based innovative REMSTART package to reduce mortality in advanced stage HIV patients starting antiretroviral therapy in Tanzania

Acronym	TRIP (Reference Number: EDCTP-CSA-2014-279)
Duration	01/03/2016 - 28/02/2019
Project Topic	Mortality from AIDS remains high in sub-Saharan Africa where HIV diagnosis and presentation to care are often delayed. Our recently EDCTP funded REMSTART trial published in the lancet, the findings showed that a simple relatively low-cost intervention, comprising a short period of home support for patients starting ART with advanced disease combined with screening for Cryptococcal meningitis reduced mortality substantially by 28%. Acceleration of the translation of these findings from research into policy and practice could reduce dramatically the mortality rates in African ART programs. The TRIP study aimsto assess the effectiveness and feasibility of large-scale application of the proven package to reduce mortality in advanced HIV-infected patients starting on ART in routine health system in urban and rural settings. The study design is involving sequential step up wedged implementation of the intervention in a staggering manner. The intervention package is being implemented in total of 18 clinics. The package involves 1) cryptococcal antigen screening plus pre-emptive treatment with fluconazole for antigen positives, and 2) weekly mobile massaging for the first month then monthly for the next three months. A total 5580 participants with CD4 less 200 will be screened to get a required sample of 620. The primary outcome will be all cause mortality for 12months.The activities have been packed into work packages 1, 2, 3 and 4. Progress of package 1 Agreements: All parties have signed the grant contract in February 2016. The memorandum (contract) of understanding between the consortiums has been signed in September 2016 by majority of parties except the Ministry of Health in Tanzania.. Project management group: All committees for the study have been formed and these include; TRIP steering committee, Project operational committee, Project Implementation committee and the Data Safety Monitoring committee Investigators meetings held during the period: Several study project meetings have been held during the reporting period; five implementation (4 May 2016, 19 July 2016, 13 August 2016, 13 Jan 2017 and 9 Feb 2017) and four operational (06 may 2016, 18 July 2016, 9th to 12th August 2016, and 13 Feb 2017) committees meetings have been conducted. Daily On-going Activities: The coordinating team holds weekly meetings at the central office. Data management: The data unit had had several meetings discussing on finalization of CRF, database development. The project received frequent support from northern team (Liverpool& St Georges). Progress of package 2 The baseline profile Study coordination team visited facilities in Morogoro rural between 23 – 27 May 2016 and Dar es Salaam between 20 – 28 June 2016. The following were done during the visit: 1) Introducing the project to administrative, HIV clinics, identify key staffs (focal persons) to work with TRIP and assessing their readiness, Assessing the current patient clinical pathways and how could be adapted for algorithm implementation of the TRIP project, Current laboratory pathways and how best adapted (testing for CD4, CrAg test]. Our observation from rural settings showed half of the facilities lack CD4 counts machines and those with CD4 machines are also experiencing challenges of shortages of cartridges/reagents and lack of machines maintenance. The programme of “Test and Treat” has been started in most of the urban centres and may have an impact on our study. Priority is currently given to viral load testing rather than CD4 counts which is our entry criterion. Randomisation; Randomisation was done in November 2016 by an independent investigator. The randomisation was stratified by urban and rural and assumes intervention to deferred arm (control) ratio of 2:1 in each. From the canters listed, the list showed all possible allocation combinations that would result in the average number of clients being website.
Website	visit project website
Network	EDCTP2
Call	Maximising the impact of EDCTP research: translation of research results into policy and practice

Project partner

Number	Name	Role	Country
1	National Institute for Medical Research	Coordinator	Tanzania
2	Liverpool School of Tropical Medicine	Partner	United Kingdom
3	Ministry of Health, Community Development, Gender, Elderly and Children	Partner	Tanzania
4	St George’s Hospital Medical School	Partner	United Kingdom