NCT03610815

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

Completed Phase 4 Last updated 6 October 2025

What this trial tests

Phase 4 trial testing Screening, Brief Intervention, Referral to Treatment in mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment in 540 participants. Completed in 31 August 2025.

Timeline

1 October 2021

Primary endpoint
31 August 2025

31 August 2025

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	540
Start date	1 October 2021
Primary completion	31 August 2025
Estimated completion	31 August 2025
Sites	1 location across Mozambique

Drugs / interventions tested

• Screening, Brief Intervention, Referral to Treatment

Conditions studied

• mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment — all drugs for mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment →
• SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy — all drugs for SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy →

Sponsor

New York State Psychiatric Institute

Who can join

18 and older, any sex, with mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment or SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries.
   Greene MC, Kane J, Alto M, Giusto A, et al · · 2023 · cited 7× · PMID 37158538 · DOI 10.1002/14651858.cd013350.pub2
2. Scale-Up Study Protocol of the Implementation of a Mobile Health SBIRT Approach for Alcohol Use Reduction in Mozambique.
   Suleman A, Mootz JJ, Feliciano P, Nicholson T, et al · · 2021 · cited 6× · PMID 34126774 · DOI 10.1176/appi.ps.202000086