Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America

Alcohol Use Disorder Clinical Trial

— SCALA  

Official title:

Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524599
• Other study ID #: UMFHMLCapH2020
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2024
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A quasi-experimental study will compare primary health care-based prevention and management of alcohol use disorder, operationalized by heavy drinking, in three intervention cities from Colombia, Mexico and Peru with three comparator cities from the same countries. In the implementation cities, primary health care units (PHCUs) will receive training embedded within ongoing supportive municipal action over an 18-month implementation period. In the comparator cities, practice as usual will continue at both municipal and PHCU levels. The primary outcome will be the proportion of consulting adult patients intervened with (screened and advice given to screen positives).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any fully trained medical practitioner, nurse or practice assistant

• Non-temporary employment contract

• Working in the selected primary health care centre

• Involved in medical and/or preventive care

Exclusion Criteria:

• Not a fully trained medical practitioner, nurse or practice assistant

• Having a temporary employment contract

• Not working in the selected primary health care centre

• Not involved in medical and/or preventive care

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Other:
• Intervention municipality
In intervention municipalities, primary health care centres and the providers working within them will receive training and a range of community support mechanisms.

Locations

Country	Name	City	State
Colombia	Health Services Unit Fray Bartolomé de las Casas	Bogota

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University	Newcastle University, Technische Universität Dresden

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of consulting adult patients (aged 18+ years) intervened	The number of AUDIT-C positive patients that received oral advice or referral for advice to another provider in or outside the primary health care centre (PHCC), divided by the total number of adult consultations of the participating providers per provider and per PHCC	18 months
Secondary	Proportion of patients screened	The proportion of patients screened will be calculated as the number of completed screens divided by the total number of consultations of all adult patients per participating provider, and averaged per participating PHCC	18 months
Secondary	Proportion of patients advised	The proportion of patients advised will be calculated as the number of brief interventions delivered (received oral brief advice, and/or were referred to another provider in or outside the practice), divided by the total number of screen positives per participating provider and averaged per participating PHCC	18 months