NCT03573167

Brief Summary

The primary objective of this study was to test whether motivational interviewing (MI) provided over the mobile phone would reduce alcohol use among adults, including people living with HIV/AIDS, visiting primary care in Kenya. Heavy alcohol users voluntarily consented to being randomized to one of three study arms: standard in-person MI, mobile MI, or waitlist control receiving no intervention for 1 month followed by mobile MI. Alcohol use problems were assessed using validated screeners and changes in alcohol use were assessed at 1 month and 6 months after receiving the intervention. The investigators hypothesized that alcohol use would reduce after MI treatment compared to waitlist control, there would be no difference between standard in-person MI and mobile MI, and these reductions would be sustained out to six months following the intervention.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

June 1, 2018

Last Update Submit

June 18, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) from baseline to one (1) month.

    The investigators compared the change in AUDIT-C alcohol use score from baseline to one (1) month after the intervention between the investigators' three study arms.

    1 month

  • Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test (AUDIT) and AUDIT-C from baseline to six (6) months.

    The investigators compared the change in AUDIT and AUDIT-C alcohol use scores from baseline to six (6) months after the intervention between the investigators' two active study arms: 1) In-Person Motivational Interviewing (MI) and 2) Mobile MI.

    6 months

Secondary Outcomes (2)

  • Reduction in alcohol use score as measured by the AUDIT and AUDIT-C moderated by HIV co-morbidity from baseline to one (1) month and from baseline to six (6) months.

    1 and 6 months

  • Reduction in alcohol use score as measured by the AUDIT moderated by mental health co-morbidity, as measured by the Achenbach System of Empirically Based Assessments (ASEBA) Adults Self-Report, from baseline to six (6) months.

    6 months

Study Arms (3)

In-Person Motivational Interviewing

ACTIVE COMPARATOR

In-Person Motivational Interviewing (MI) is the standard form of MI treatment delivered in person face to face at the primary care office. MI is a type of brief intervention that uses open-ended questions, affirmations, reflective listening, and summarizing as key tools and has been shown to treat a range of problem behaviors, including alcohol use disorders, by helping participants to identify and address ambivalence towards changing the behavior. MI is delivered in a communicative style that promotes individual autonomy and improves self-efficacy. The investigator provides counseling in-person with the participant for one session of MI lasting approximately 30 minutes.

Behavioral: In-Person Motivational Interviewing (MI)

Mobile MI

EXPERIMENTAL

Mobile Motivational Interviewing (MI) is delivered by a counselor over the mobile phone, rather than in-person (face-to-face). MI is a type of brief intervention that uses open-ended questions, affirmations, reflective listening, and summarizing as key tools and has been shown to treat a range of problem behaviors, including alcohol use disorders, by helping the patient to identify and address ambivalence towards changing the behavior. MI is delivered in a communicative style that promotes individual autonomy and improves self-efficacy. The investigator provides counseling over the mobile phone with the participant for one session of mobile MI lasting approximately 30 minutes.

Behavioral: Mobile Motivational Interviewing (MI)

Waitlist Control

NO INTERVENTION

After consenting to participate in the study, the Waitlist control participants receive no intervention for one (1) month, and then the Waitlist control participants are contacted by the investigators for follow up..

Interventions

This is a counseling intervention to support behavior change conducted in-person (face-to-face) between the investigator and the participant.

In-Person Motivational Interviewing

This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant

Mobile MI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults visiting the primary care clinic and screening positive for potential alcohol use problems.

You may not qualify if:

  • Persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Valerie Harder, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 29, 2018

Study Start

September 30, 2014

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share