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

NCT ID: NCT03610815

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-08-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

mSBIRT

Mobile Screening, Brief Intervention, Referral to Treatment (mSBIRT)

Group Type: EXPERIMENTAL

Screening, Brief Intervention, Referral to Treatment

Intervention Type: BEHAVIORAL

Screening, Brief Intervention, Referral to Treatment

SBIRT-CTS),

Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision strategy

Group Type: ACTIVE_COMPARATOR

Screening, Brief Intervention, Referral to Treatment

Intervention Type: BEHAVIORAL

Screening, Brief Intervention, Referral to Treatment

Interventions

Screening, Brief Intervention, Referral to Treatment

Screening, Brief Intervention, Referral to Treatment

Intervention Type: BEHAVIORAL

Other Intervention Names

Motivational Interviewing

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Other clinic staff from this clinics or other clinics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Milton L. Wainberg, MD

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Milton L Wainberg, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

MIHER: Mozambique Institute for Health Education and Research

Maputo, Cidade de Maputo, Mozambique

Countries

Mozambique

References

Morgenstern J, Irwin TW, Wainberg ML, Parsons JT, Muench F, Bux DA Jr, Kahler CW, Marcus S, Schulz-Heik J. A randomized controlled trial of goal choice interventions for alcohol use disorders among men who have sex with men. J Consult Clin Psychol. 2007 Feb;75(1):72-84. doi: 10.1037/0022-006X.75.1.72.

Reference Type: BACKGROUND

PMID: 17295566 (View on PubMed)

Irwin TW, Morgenstern J, Parsons JT, Wainberg M, Labouvie E. Alcohol and sexual HIV risk behavior among problem drinking men who have sex with men: An event level analysis of timeline followback data. AIDS Behav. 2006 May;10(3):299-307. doi: 10.1007/s10461-005-9045-7.

Reference Type: BACKGROUND

PMID: 16482407 (View on PubMed)

Elliott JC, Aharonovich E, O'Leary A, Wainberg M, Hasin DS. Drinking motives as prospective predictors of outcome in an intervention trial with heavily drinking HIV patients. Drug Alcohol Depend. 2014 Jan 1;134:290-295. doi: 10.1016/j.drugalcdep.2013.10.026. Epub 2013 Nov 5.

Reference Type: BACKGROUND

PMID: 24286967 (View on PubMed)

Elliott JC, Aharonovich E, O'Leary A, Wainberg M, Hasin DS. Drinking motives among HIV primary care patients. AIDS Behav. 2014 Jul;18(7):1315-23. doi: 10.1007/s10461-013-0644-4.

Reference Type: BACKGROUND

PMID: 24165984 (View on PubMed)

Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.

Reference Type: BACKGROUND

PMID: 23432593 (View on PubMed)

Aharonovich E, Hatzenbuehler ML, Johnston B, O'Leary A, Morgenstern J, Wainberg ML, Yao P, Helzer JE, Hasin DS. A low-cost, sustainable intervention for drinking reduction in the HIV primary care setting. AIDS Care. 2006 Aug;18(6):561-8. doi: 10.1080/09540120500264134.

Reference Type: BACKGROUND

PMID: 16831783 (View on PubMed)

Oquendo MA, Duarte C, Gouveia L, Mari JJ, Mello MF, Audet CM, Pinsky I, Vermund SH, Mocumbi AO, Wainberg ML. Building capacity for global mental health research: challenges to balancing clinical and research training. Lancet Psychiatry. 2018 Aug;5(8):612-613. doi: 10.1016/S2215-0366(18)30097-X. Epub 2018 Apr 5. No abstract available.

Reference Type: BACKGROUND

PMID: 29628365 (View on PubMed)

Suleman A, Mootz JJ, Feliciano P, Nicholson T, O'Grady MA, Wall M, Mandell DS, Stockton M, Teodoro E, Anube A, Novela A, Mocumbi AO, Gouveia L, Wainberg ML. Scale-Up Study Protocol of the Implementation of a Mobile Health SBIRT Approach for Alcohol Use Reduction in Mozambique. Psychiatr Serv. 2021 Oct 1;72(10):1199-1208. doi: 10.1176/appi.ps.202000086. Epub 2021 Jun 15.

Reference Type: DERIVED

PMID: 34126774 (View on PubMed)

Other Identifiers

7493

Identifier Type: -

Identifier Source: org_study_id