Reducing the diagnostic and treatment gap for priority mental, neurological and substance misuse disorders in primary care in rural Kenya: Results of a stepped wedge cluster randomized trial from the EPINA study

ABSTRACTBackground: In resource-limited settings, care for mental, neurological and substance misuse (MNS) disorders has been integrated into primary healthcare facilities (PHC) by training primary health workers (PHW) on the use of the mental health Gap Action Program Intervention Guide (mhGAP-IG). Feasibility and effectiveness of implementing all modules on a large scale in real-life clinical settings, remains under-researched.Methods: Between August 2021 and November 2022, we implemented the mhGAP-IG among PHW in PHC. The primary outcome was the proportion of clinical consultations for depression, dementia, psychotic disorders, suicidality, substance misuse disorders, epilepsy and dementia. Secondary outcomes were changes in PHW levels of stigma, patients’ severity of illness, disability, and quality of life. Patients were blinded to group assignment.Findings: 127 PHC were randomized to 16 clusters and 172 PHW were trained. During the study period 5,320,423 adult clinical consultations for all illnesses were made. Compared to baseline, the number of clinical consultations for epilepsy (β= 5·80, 95% CI= 4·37, 7·22 p<0·01 ), depression (β= 0·35, 95% CI= 0·28, 0·41 , p<0·00), dementia (β= 0·13, 95% CI= 0·10, 0·16, p<0.01) and substance misuse disorders (β=0·05, 95% CI=0·04, 0·07, p<0·01) significantly improved. PHW’s levels of stigma (knowledge, attitude and, behavior) and all patient outcomes significantly improved post-intervention.Interpretation: Implementing all modules of the mhGAP-IG is feasible in real-world PHC. It is effective in lowering the diagnostic and treatment gap for MNS, improving PHW’s stigma and patient outcomes.Funding: National Institute for Health and Care Research [NIHR200134]Trial registration: Pan African Clinical Trials registry [PACTR202011741472301]