Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique

Study Overview
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Brief Summary
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Hazardous drinking (HD) is a major public health burden worldwide with significant morbidity and mortality. To reduce HD, the World Health Organization (WHO) recommends using Screening, Brief Intervention, Referral to Treatment (SBIRT). Mobile health technology (mHealth), such as the mSBIRT app, is a promising tool for widespread cost-effective delivery of evidence-based HDS by community health workers (CHWs) because of its potential to increase fidelity, effectiveness, and sustainability. Community I-STAR Mozambique comprises three phases: 1) mSBIRT adaptation, 2) a cluster-randomized trial, and 3) scale-up of the most cost-effective intervention. Community I-STAR Mozambique will scale-up a cost effective, sustainable program and inform policy applicable to Mozambique and other LMICs.

Detailed Description
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Hazardous drinking (HD) is a major public health burden worldwide with significant morbidity and mortality. The prevention and treatment gap associated with this global burden requires that efficacious interventions be scaled-up, leveraging existing platforms and participation of policy makers ready to apply and sustain evidence-informed policies over time. To reduce HD, the WHO recommends using Screening, Brief Intervention, Referral to Treatment (SBIRT) and the mental health Gap Action Programme guidelines (mhGAP). As low- and middle-income countries (LMIC) embrace SBIRT and mhGAP for community based HD services (HDS), a main scale-up challenge is ensuring effectiveness, fidelity, and sustainability of services. Mobile health technology (mHealth), such as the mSBIRT app, is a promising tool for widespread cost-effective delivery of evidence-based HDS by community health workers (CHWs) because of its potential to increase fidelity, effectiveness, and sustainability. The proposed project, Community I-STAR (Implementation of SBIRT using Technology for Alcohol use Reduction) Mozambique, will leverage the following existing Mozambique Ministry of Health (MoH) programs: (1) a task-shifting strategy training psychiatric technicians (PsyTs) to use the mhGAP; (2) the WHO-funded epilepsy community program delivered by CHWs; and (3) an mHealth program for malaria, pneumonia, and diarrhea (inSCALE - Innovations at Scale for Community Access and Lasting Effects). These currently operating programs set the stage for the use of mSBIRT by CHWs to deliver community HDS in Mozambique and generate policy for scale-up of government-funded community HDS harnessing existing human resources. Community I-STAR Mozambique comprises three phases: 1) mSBIRT adaptation, 2) a cluster-randomized trial, and 3) scale-up of the most cost-effective intervention. A formative phase to adapt mSBIRT to Mozambique's context/culture, will be followed by a 2-year, cluster-randomized, hybrid effectiveness-implementation type 2 trial in 12 districts: 6 districts randomized to receive mSBIRT and 6 to an SBIRT Conventional Training and Supervision strategy (SBIRT-CTS), with both arms delivered by CHWs. The arm showing higher cost-effectiveness in the 2-year trial will be scaled up to the other 6 districts for 12 cross-over months. Throughout the trial and the cross-over scale-up, qualitative and process data will complement quantitative assessments to examine implementation, sustainability, and scale-up. This approach redefines work roles without requiring new human resources, and it comports with the MoH's commitment to implementing HDS. Evidence-based practices (SBIRT) will a) build capacity for complete task-shifting of sustainable community-HDS practices; and b) use implementation tools to examine implementation and effectiveness of two SBIRT delivery strategies followed by evaluation of scale-up of the most cost-effective strategy. Community I-STAR Mozambique will scale-up a cost effective, sustainable program and inform policy applicable to Mozambique and other LMICs.

Official Title
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Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique

Conditions
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mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment, SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy

Intervention / Treatment
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* Behavioral: Screening, Brief Intervention, Referral to Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community Health Workers working in the randomized clinics, Portuguese speakers Exclusion Criteria: Other clinic staff from this clinics or other clinics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Effectiveness-Implementation Hybrid 2 Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mSBIRT<br>Mobile Screening, Brief Intervention, Referral to Treatment (mSBIRT) | Behavioral: Screening, Brief Intervention, Referral to Treatment<br>* Screening, Brief Intervention, Referral to Treatment<br>* Other names: Motivational Interviewing;|
| Active Comparator: SBIRT-CTS),<br>Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision strategy | Behavioral: Screening, Brief Intervention, Referral to Treatment<br>* Screening, Brief Intervention, Referral to Treatment<br>* Other names: Motivational Interviewing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation - Reach | Number of individual who access care from among those who need care | From baseline to 6 months | 
| Clinical Effectiveness - AUDIT | Alcohol Use Disorders Identification Test | From baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Implementing New Strategies (COINS) | Measures cost of implementing interventions | through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, SBIRT, Mobile Technology, Implementation Science, Dissemination Research, Hybrid Effectiveness-Implementation Design