PO 8447 ROBUST CLINICAL TRIALS ARE NOT ENOUGH: OVERCOMING OPERATIONAL CHALLENGES FOR IMPLEMENTING REMSTART INTERVENTION PACKAGE (TRIP STUDY) INTO ROUTINE PRACTICE

Abstract

BackgroundThe REMSTART trial identified an effective package (cryptococcal antigen (CrAg) screening and enhanced antiretroviral therapy (ART) adherence support) that reduced all-cause mortality in advanced HIV (CD4 ≤200 cells/mm3) by 28% compared to standard of care. The introduction of this package at clinic level has been necessary to impact routine care practices in Tanzania.MethodsThe TRIP study is cluster-randomised. The intervention package was implemented in 16 routine care facilities (early arm) whilst 8 facilities continued with standard of care (deferred arm). At the end of 12 months follow-up, the intervention was implemented in the deferred facilities. The primary endpoint is all-cause mortality at 1 year.ResultsImplementation of the REMSTART intervention into routine care services has highlighted the following challenges: 1) Baseline CD4 testing: half (4/8) of rural facilities had no CD4 machines and in a further 3/8 there was a lack of reagents needed for CD4 testing. Clinical staging has replaced inclusion criterion where CD4 testing is not available; 2) Heavy staff workload in routine care; regular discussion with policymakers and workshops enhanced the take-up of the package; 3) Timing of ART: the Ministry of Health has updated national guidelines to include the package and delay ART by 2 weeks in CrAg-positives.ConclusionIt has proven essential to engage with policymakers and programme managers from the outset, i.e. during the REMSTART trial itself and the following TRIP implementation study. The Ministry of Health has now changed the national HIV guidelines to include the REMSTART package and develop training modules for CrAg screening in all regional hospitals. The TRIP study has revealed key issues that must be addressed to allow scaling up the interventions.