Skip to main content
OpenTrials
Completed

NCT Number: NCT03610815

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MIHER: Mozambique Institute for Health Education and Research

Maputo, Cidade de Maputo, 1101, Mozambique

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Community Health Workers working in the randomized clinics, Portuguese speakers

Exclusion criteria

  • Other clinic staff from this clinics or other clinics

Treatment and study plan

Screening, Brief Intervention, Referral to Treatment

Behavioral

Screening, Brief Intervention, Referral to Treatment

Other names: Motivational Interviewing

Primary outcomes

  1. Implementation - Reach

    Time frame: From baseline to 6 months

    Number of individual who access care from among those who need care

  2. Clinical Effectiveness - AUDIT

    Time frame: From baseline to 6 months

    Alcohol Use Disorders Identification Test

Secondary outcomes

  1. Cost of Implementing New Strategies (COINS)

    Time frame: through study completion, an average of 2 years

    Measures cost of implementing interventions

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Columbia University
  • University of Pennsylvania

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2018
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.