The effect of engaging unpaid informal providers on case detection and treatment initiation rates for TB and HIV in rural Malawi (Triage Plus): A cluster randomised health system intervention trial

BACKGROUND: The poor face barriers in accessing services for tuberculosis (TB) and Human Immuno-deficiency Virus (HIV) disease. A cluster randomised trial was conducted to investigate the effectiveness of engaging unpaid informal providers (IPs) to promote access in a rural district. The intervention consisted of training unpaid IPs in TB and HIV disease recognition, sputum specimen collection, appropriate referrals, and raising community awareness. METHODS: In total, six clusters were defined in the study areas. Through a pair-matched cluster randomization process, three clusters (average cluster population = 200,714) were allocated to receive the intervention in the Early arm. Eleven months later the intervention was rolled out to the remaining three clusters (average cluster population = 209,564)—the Delayed arm. Treatment initiation rates for TB and Anti-Retroviral Therapy (ART) were the primary outcome measures. Secondary outcome measures included testing rates for TB and HIV. We report the results of the comparisons between the Early and Delayed arms over the 23 month trial period. Data were obtained from patient registers. Poisson regression models with robust standard errors were used to express the effectiveness of the intervention as incidence rate ratios (IRR). RESULTS: The Early and Delayed clusters were well matched in terms of baseline monthly mean counts and incidence rate ratios for TB and ART treatment initiation. However there were fewer testing and treatment initiation facilities in the Early clusters (TB treatment n = 2, TB testing n = 7, ART initiation n = 3, HIV testing n = 20) than in the Delayed clusters (TB treatment n = 4, TB testing n = 9, ART initiation n = 6, HIV testing n = 18). Overall there were more HIV testing and treatment centres than TB testing and treatment centres. The IRR was 1.18 (95% CI: 0.903–1.533; p = 0.112) for TB treatment initiation and 1.347 (CI:1.00–1.694; p = 0.049) for ART initiation in the first 12 months and the IRR were 0.552 (95% CI:0.397–0.767; p<0.001) and 0.924 (95% CI: 0.369–2.309, p = 0.863) for TB and ART treatment initiations respectively for the last 11 months. The IRR were 1.152 (95% CI:1.009–1.359, p = 0.003) and 1.61 (95% CI:1.385–1.869, p<0.001) for TB and HIV testing uptake respectively in the first 12 months. The IRR was 0.659 (95% CI:0.441–0.983; p = 0.023) for TB testing uptake for the last 11 months. CONCLUSIONS: We conclude that engagement of unpaid IPs increased TB and HIV testing rates and also increased ART initiation. However, for these providers to be effective in promoting TB treatment initiation, numbers of sites offering TB testing and treatment initiation in rural areas should be increased. TRIAL REGISTRATION: ClinicalTrials.gov NCT02127983.