Mobile Phone-Based Motivational Interviewing in Kenya
1 other identifier
interventional
322
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedFirst Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedJune 29, 2018
June 1, 2018
1.3 years
June 1, 2018
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 COMPARATORIn-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.
Mobile MI
EXPERIMENTALMobile 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.
Waitlist Control
NO INTERVENTIONAfter 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.
This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie Harder, PhD
University of Vermont
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