A culturally-safe primary care intervention for migrant/refugee women suffering domestic violence and abuse: HARMONY-a pragmatic cluster randomised controlled trial

BACKGROUND: Immigrant women can experience high rates of domestic violence and abuse (DVA) and migration trauma. Family or general practitioners (GPs) have limited DVA training or support to manage culturally competent DVA practice and associated trauma. The HARMONY study aimed to increase culturally competent DVA identification and referral among all, but especially migrant/refugee women from South-Asia, attending Australian GP clinics. METHODS: Twenty-four GP clinics were recruited among two South-Asian communities in Northwest and Southeast Melbourne for a pragmatic cluster randomised controlled trial. Eligible clinics (i) employed ≥ 1 South-Asian GPs, (ii) used 1 of 2 electronic software programs, and (iii) agreed to anonymised, aggregated data extraction from computerised records. The intervention comprised (a) GP DVA educator and bilingual South-Asian DVA advocate co-delivering 4 h of online accredited culturally competent DVA training, and (b) 12 months follow-up support by the DVA advocate to intervention clinics. Comparison clinics offered routine care and were offered DVA training following the intervention's completion. Investigators and statistician were blinded to allocation, but clinics and frontline staff were not. Aggregated, anonymised routine data were extracted for primary outcomes of DVA identification and referral at 12 and 15 months. Per-protocol adjusted, intention-to-treat analysis using Poisson regression. RESULTS: Five of 24 GP recruited clinics withdrew before the trial began due to COVID-19. At baseline, GPs recorded DVA in 0.6% of 45,438 women, (but 0.4% among South-Asian women) and none recorded DVA referrals. Identification trended up in both arms, but we found no evidence of difference in DVA identification at 12 months in Intervention (0.98%, 252/25816) vs Comparison (0.88%, 199/22546), IRR 1.17 (95% CI 0.60 to 2.28) or at 15 months Intervention 1.01% (287/26218) vs Comparison 0.96% (217/22643), IRR 1.17 (95% CI 0.60-2.67). Referrals were rare (Int 14/252 vs Comp 6/199). 6/14 Intervention referrals were South-Asian women. No adverse events were reported. CONCLUSIONS: While we found no evidence of HARMONY effectiveness, COVID-19 may have undermined its implementation. The model is promising for future research and refinement for clinics motivated to improve DVA management with diaspora minority ethnic communities. TRIAL REGISTRATION: ACTRN12618001845224p registered:13/11/2018.