PLoS One. 2026 Aug 17;21(8):e0352643. doi: 10.1371/journal.pone.0352643. eCollection 2026.
ABSTRACT
In resource-limited settings, improving care for mental, neurological and substance misuse (MNS) disorders is essential. This study evaluated the feasibility and effectiveness of implementing all adult modules of the WHO mental health Gap Action Programme Intervention Guide (mhGAP-IG) in primary healthcare (PHC) in rural Kenya through training non-specialist primary healthcare workers. We conducted a stepped-wedge cluster randomized trial across 127 public primary care facilities in Kilifi County, Kenya. Facilities were grouped into 16 clusters and randomly assigned to one of 16 monthly intervention start dates between August 2021 and November 2022. All clusters began in the control condition and sequentially crossed over to the intervention. The intervention comprised a 10-day mhGAP-IG training followed by quarterly supportive supervision. The primary outcome was the monthly rate of clinical consultations for MNS disorders per 100,000 outpatient consultations. Secondary outcomes included healthcare worker stigma and patient-level measures of illness severity, disability, and quality of life. A total of 172 healthcare workers were trained, and 5,320,423 adult outpatient consultations were recorded. Compared to the control period, the monthly rate of epilepsy diagnoses increased from 191.35 to 395.49 per 100,000 consultations (crude absolute increase 204.13 per 100,000), with an adjusted intervention effect of β = 119.19 (95% CI 34.70-203.67; p = 0.006). Depression diagnoses increased from 1.41 to 15.24 per 100,000 consultations (crude increase 13.82 per 100,000; β = 9.70, 95% CI 5.69-13.71; p < 0.001), dementia from 0.25 to 5.58 (crude increase 5.33 per 100,000; β = 4.11, 95% CI 2.51-5.71; p < 0.001), and substance misuse disorders from 0.04 to 2.14 (crude increase 2.10 per 100,000; β = 1.78, 95% CI 0.95-2.61; p < 0.001). Although crude increases were observed for psychosis (18.55 to 49.38 per 100,000), suicidality (0.17 to 0.46), and a decrease for other mental health complaints (108.44 to 81.15), the adjusted intervention effects for these outcomes were not statistically significant. Healthcare worker stigma and patient outcomes improved significantly. Large-scale implementation of mhGAP-IG in rural Kenyan PHC was feasible and associated with improved detection of MNS disorders and better provider and patient outcomes. Further studies in diverse settings are needed to assess generalizability.
TRIAL REGISTRATION: Pan African Clinical Trials registry [PACTR202011741472301].
PMID:42607024 | DOI:10.1371/journal.pone.0352643
