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

mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03610815
• Other study ID #: 7493
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: New York State Psychiatric Institute
• Contact: Milton L Wainberg, MD
• Phone: 6467746430
• Email: mlw35[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Other clinic staff from this clinics or other clinics

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Screening, Brief Intervention, Referral to Treatment
Screening, Brief Intervention, Referral to Treatment

Locations

Country	Name	City	State
Mozambique	MIHER: Mozambique Institute for Health Education and Research	Maputo

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Columbia University, University of Pennsylvania

Country where clinical trial is conducted

Mozambique, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation - Reach	Number of individual who access care from among those who need care	From baseline to 6 months
Primary	Clinical Effectiveness - AUDIT	Alcohol Use Disorders Identification Test	From baseline to 6 months
Secondary	Cost of Implementing New Strategies (COINS)	Measures cost of implementing interventions	through study completion, an average of 2 years