A Phase 4 interventional study of Screening, Brief Intervention, Referral to Treatment in mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment and SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy, sponsored by New York State Psychiatric Institute. Completed at 1 site in Mozambique. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Health services research
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.
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.
New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Mobile Screening, Brief Intervention, Referral to Treatment (mSBIRT)
Behavioral: Screening, Brief Intervention, Referral to Treatment
Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision strategy
Behavioral: Screening, Brief Intervention, Referral to Treatment
Screening, Brief Intervention, Referral to Treatment
Also known as: Motivational Interviewing
Implementation - Reach
Number of individual who access care from among those who need care
Time frame: From baseline to 6 months
Clinical Effectiveness - AUDIT
Alcohol Use Disorders Identification Test
Time frame: From baseline to 6 months
Cost of Implementing New Strategies (COINS)
Measures cost of implementing interventions
Time frame: through study completion, an average of 2 years
Plan to share: Yes — Investigators will use the Global Mental Health Program at Columbia University (GMHP@CU) to make data available requiring acknowledgement of the the source of data and anonymity of research participants. Public codebooks and analysis protocols will be available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 3 years after study completion
Access criteria: Described above in the plan description
Ran from Oct 2021 to primary completion in Aug 2025, 46 months.
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