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

April 12, 2024 updated by: Maastricht University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

690

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia, 10366
        • Health Services Unit Fray Bartolomé de las Casas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention municipality
In the intervention municipalities, primary health care providers will receive ongoing training and support in undertaking screening and brief advice for heavy drinking. They will also receive community-based five adoption mechanisms and five support systems.
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.
No Intervention: Comparator municipality
In the comparator municipalities, the primary health care providers will be given a summary card of screening and brief advice for heavy drinking, with no instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of consulting adult patients (aged 18+ years) intervened
Time Frame: 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients screened
Time Frame: 18 months
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
Proportion of patients advised
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Collaborators

Newcastle University
Technische Universität Dresden

Investigators

  • Principal Investigator: Peter Anderson, MD, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMFHMLCapH2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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