Adaptation of the World Health Organization Electronic Mental Health Gap Action Programme Intervention Guide App for Mobile Devices in Nepal and Nigeria: Protocol for a Feasibility Cluster Randomized Controlled Trial

Abstract

Background There is a growing global need for scalable approaches to training and supervising primary care workers (PCWs) to deliver mental health services. Over the past decade, the World Health Organization Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) and associated training and implementation guidance have been disseminated to more than 100 countries. On the basis of the opportunities provided by mobile technology, an updated electronic Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG) is now being developed along with a clinical dashboard and guidance for the use of mobile technology in supervision. Objective This study aims to assess the feasibility, acceptability, adoption, and other implementation parameters of the e-mhGAP-IG for diagnosis and management of depression in 2 lower-middle-income countries (Nepal and Nigeria) and to conduct a feasibility cluster randomized controlled trial (cRCT) to evaluate trial procedures for a subsequent fully powered trial comparing the clinical effectiveness and cost-effectiveness of the e-mhGAP-IG and remote supervision with standard mhGAP-IG implementation. Methods A feasibility cRCT will be conducted in Nepal and Nigeria to evaluate the feasibility of the e-mhGAP-IG for use in depression diagnosis and treatment. In each country, an estimated 20 primary health clinics (PHCs) in Nepal and 6 PHCs in Nigeria will be randomized to have their staff trained in e-mhGAP-IG or the paper version of mhGAP-IG v2.0. The PHC will be the unit of clustering. All PCWs within a facility will receive the same training (e-mhGAP-IG vs paper mhGAP-IG). Approximately 2-5 PCWs, depending on staffing, will be recruited per clinic (estimated 20 health workers per arm in Nepal and 15 per arm in Nigeria). The primary outcomes of interest will be the feasibility and acceptability of training, supervision, and care delivery using the e-mhGAP-IG. Secondary implementation outcomes include the adoption of the e-mhGAP-IG and feasibility of trial procedures. The secondary intervention outcome—and the primary outcome for a subsequent fully powered trial—will be the accurate identification of depression by PCWs. Detection rates before and after training will be compared in each arm. Results To date, qualitative formative work has been conducted at both sites to prepare for the pilot feasibility cRCT, and the e-mhGAP-IG and remote supervision guidelines have been developed. Conclusions The incorporation of mobile digital technology has the potential to improve the scalability of mental health services in primary care and enhance the quality and accuracy of care. Trial Registration ClinicalTrials.gov NCT04522453; https://clinicaltrials.gov/ct2/show/NCT04522453. International Registered Report Identifier (IRRID) PRR1-10.2196/24115

Protocol for intervention development to improve adolescent perinatal mental health in Kenya and Mozambique: The INSPIRE project

“…Our previous work in Mozambique illustrated the potential for using human-centred design, to actively engage adolescents and other stakeholders in the identification of challenges to adolescent perinatal mental health and brainstorming of potential solutions (Taylor Salisbury et al, 2021). The Innovative Approaches for Adolescent Perinatal Wellbeing (INSPIRE) project builds upon this work by expanding to a second area in Mozambique and an additional country (Kenya).…”

“…This protocol describes the methods applied in Phase 1 of this research programme. While unusual to publish a protocol focused on formative work, the lack of deep description of the incorporation of participatory research within global health (Salisbury et al., 2021) demonstrates a need for transparency and clarity of the methods followed.…”

Implementation Research in Nepal – A Scoping Review, 2015-2022

“…The details and the conclusions of the included studies are presented in Table 2. The objectives of the studies are diverse that includes measuring implementation outcomes; 14,15 reporting implementation challenges; 16 adaptation; 17,18 exploring facilitators and barriers to implementation; 19,20 capacity building; 21 exploring readiness and capacity; [22][23][24][25][26][27][28] identify or test implementation strategy; [29][30][31][32][33] and stakeholder engagement. 9,34 Nine articles evaluated implementation.…”

“…[14][15][16][17]29,30,32,33,35 These articles clearly specified the targeted EBP and the implementation strategies to adoption and/or implementation. Multiple implementation outcomes were reported including: (a) reach, 29,30,33 (b) effectiveness, 30,33 (c) adoption, 15,16,30,33 (d) implementation, 30,36 (e) maintenance; 30 (f) feasibility, [14][15][16][17]28 (g) acceptability, (h) fidelity, 16,17 (i) cost, 16,17 (j) acceptability, 17 (k) appropriateness, 16,17 (l) penetration, 17 and (m) sustainability. 14,16 These implementation outcomes were defined clearly based on the context and study objectives.…”

“…20 Others explored facilitators and barriers to implementing health interventions or implementation strategies. 18,19,28,31 Five studies have not reported any theory or frameworks; 15,17,19,20,31 three reported using Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM); 29,30,33 Six have used health system building blocks framework; [22][23][24][25][26][27] one used Consolidated Framework for Implementation Research (CFIR); 38 one used performance of routine information system framework; 14 one used participatory implementation research; 16 Emerald capacity building activities; 35 two used Ray and Miller stakeholder engagement framework; 9,34 and one use health system assessment approach. 37 Most of the research was funded by the European Union, National Institute of Health USA, United States Agency for International Development (USAID), Medical Research Council UK, or the WHO; four did not report funding sources; and one stated that there was no funding (Table 2).…”