Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique
Primary Purpose
mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment, SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy
Status
Recruiting
Phase
Phase 4
Locations
Mozambique
Study Type
Interventional
Intervention
Screening, Brief Intervention, Referral to Treatment
Sponsored by
About this trial
This is an interventional health services research trial for mSBIRT - Mobile Screening, Brief Intervention, Referral to Treatment focused on measuring Alcohol, SBIRT, Mobile Technology, Implementation Science, Dissemination Research, Hybrid Effectiveness-Implementation Design
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
Sites / Locations
- MIHER: Mozambique Institute for Health Education and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mSBIRT
SBIRT-CTS),
Arm Description
Mobile Screening, Brief Intervention, Referral to Treatment (mSBIRT)
Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision strategy
Outcomes
Primary Outcome Measures
Implementation - Reach
Number of individual who access care from among those who need care
Clinical Effectiveness - AUDIT
Alcohol Use Disorders Identification Test
Secondary Outcome Measures
Cost of Implementing New Strategies (COINS)
Measures cost of implementing interventions
Full Information
NCT ID
NCT03610815
First Posted
June 24, 2018
Last Updated
July 27, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03610815
Brief Title
Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique
Official Title
Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Effectiveness-Implementation Hybrid 2 Trial
Masking
Investigator
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mSBIRT
Arm Type
Experimental
Arm Description
Mobile Screening, Brief Intervention, Referral to Treatment (mSBIRT)
Arm Title
SBIRT-CTS),
Arm Type
Active Comparator
Arm Description
Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision strategy
Intervention Type
Behavioral
Intervention Name(s)
Screening, Brief Intervention, Referral to Treatment
Other Intervention Name(s)
Motivational Interviewing
Intervention Description
Screening, Brief Intervention, Referral to Treatment
Primary Outcome Measure Information:
Title
Implementation - Reach
Description
Number of individual who access care from among those who need care
Time Frame
From baseline to 6 months
Title
Clinical Effectiveness - AUDIT
Description
Alcohol Use Disorders Identification Test
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Cost of Implementing New Strategies (COINS)
Description
Measures cost of implementing interventions
Time Frame
through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milton L Wainberg, MD
Phone
6467746430
Email
mlw35@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton L Wainberg, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
MIHER: Mozambique Institute for Health Education and Research
City
Maputo
ZIP/Postal Code
1101
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alcido Nguenha
Phone
+254213180
Email
info@miher.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
3 years after study completion
IPD Sharing Access Criteria
Described above in the plan description
Citations:
PubMed Identifier
17295566
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.
Results Reference
background
PubMed Identifier
16482407
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.
Results Reference
background
PubMed Identifier
24286967
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.
Results Reference
background
PubMed Identifier
24165984
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.
Results Reference
background
PubMed Identifier
23432593
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.
Results Reference
background
PubMed Identifier
16831783
Citation
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.
Results Reference
background
PubMed Identifier
29628365
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.
Results Reference
background
PubMed Identifier
34126774
Citation
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.
Results Reference
derived
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Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique
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