mSBIRT - Mobile Screening, Brief Intervention, Referral to TreatmentPhase 4NCT03610815
Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique
A Phase 4 study testing Screening, Brief Intervention, Referral to Treatment in people with mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment and SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy, run by New York State Psychiatric Institute at 1 site in Mozambique.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment, SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy
- What is being tested?
- Screening, Brief Intervention, Referral to Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteMozambique
- Study dates
- 1 Oct 2021to 31 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community Health Workers working in the randomized clinics, Portuguese speakers
Who cannot join
- Other clinic staff from this clinics or other clinics
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
MIHER: Mozambique Institute for Health Education and Research
Maputo, Cidade de Maputo, 1101
About this study
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.
Read the 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
- Being tested
- Screening, Brief Intervention, Referral to Treatment
- Keywords
- Alcohol, SBIRT, Mobile Technology, Implementation Science, Dissemination Research, Hybrid Effectiveness-Implementation Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening, Brief Intervention, Referral to TreatmentBehavioural
Also called Motivational Interviewing
Screening, Brief Intervention, Referral to Treatment
| Study group | Role | What they receive |
|---|---|---|
| mSBIRT | Experimental | Mobile Screening, Brief Intervention, Referral to Treatment (mSBIRT) Receives: Behavioral: Screening, Brief Intervention, Referral to Treatment |
| SBIRT-CTS), | Active comparator | Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision strategy Receives: Behavioral: Screening, Brief Intervention, Referral to Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation - Reach
Number of individual who access care from among those who need care
Measured: From baseline to 6 months
Clinical Effectiveness - AUDIT
Alcohol Use Disorders Identification Test
Measured: From baseline to 6 months
Secondary outcomes (1)
Cost of Implementing New Strategies (COINS)
Measures cost of implementing interventions
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Oct 2021
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for mSBIRT - Mobile Screening, Brief Intervention, Referral to TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effectiveness-Implementation Hybrid 2 Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Pennsylvania
- Responsible party
- Principal investigator, Milton L. Wainberg, MD, New York State Psychiatric Institute
- Investigators
- Milton L Wainberg, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610815
- Sponsor's protocol ID
- 7493
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2018
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 17295566Irwin 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.
PubMed 16482407Elliott 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.
PubMed 24286967Elliott 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.
PubMed 24165984Hasin 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.
PubMed 23432593Aharonovich 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.
PubMed 16831783Oquendo 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.
PubMed 29628365Suleman 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.
PubMed 34126774
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique
- ClinicalTrials.gov ID
- NCT03610815
- Acronym / sponsor ID
- 7493
- Conditions
- mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment, SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy
- Keywords
- Alcohol, SBIRT, Mobile Technology, Implementation Science, Dissemination Research, Hybrid Effectiveness-Implementation Design
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University, University of Pennsylvania
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Effectiveness-Implementation Hybrid 2 Trial
| Arm | Type | Receives |
|---|---|---|
| mSBIRT | Experimental | Behavioral: Screening, Brief Intervention, Referral to TreatmentMobile Screening, Brief Intervention, Referral to Treatment (mSBIRT) |
| SBIRT-CTS), | Active comparator | Behavioral: Screening, Brief Intervention, Referral to TreatmentScreening, Brief Intervention, Referral to Treatment Conventional Training and Supervision strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community Health Workers working in the randomized clinics, Portuguese speakers
Key exclusion criteria (1 listed)
- Other clinic staff from this clinics or other clinics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening, Brief Intervention, Referral to TreatmentAlso: Motivational InterviewingScreening, Brief Intervention, Referral to Treatment | Behavioural | SBIRT-CTS),, mSBIRT |
Primary outcome
Implementation - Reach
Time frame: From baseline to 6 months
Number of individual who access care from among those who need care
Clinical Effectiveness - AUDIT
Time frame: From baseline to 6 months
Alcohol Use Disorders Identification Test
1 secondary outcome
Cost of Implementing New Strategies (COINS)
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 17295566Morgenstern 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.
- Background: PubMed 16482407Irwin 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.
- Background: PubMed 24286967Elliott 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.
- Background: PubMed 24165984Elliott 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.
- Background: PubMed 23432593Hasin 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.
- Background: PubMed 16831783Aharonovich 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.
- Background: PubMed 29628365Oquendo 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.
- Derived from this study: PubMed 34126774Suleman 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.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milton L Wainberg, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Screening, Brief Intervention, Referral to Treatment in people with mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment and SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy, run by New York State Psychiatric Institute at 1 site in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation - Reach (time frame: From baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610815, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.