- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03573167
Mobile Phone-Based Motivational Interviewing in Kenya
June 18, 2018 updated by: Valerie Harder, University of Vermont
Mobile Phone-Based Motivational Interviewing to Reduce Alcohol Use Problems in Kenya
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
322
Phase
- Not Applicable
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults visiting the primary care clinic and screening positive for potential alcohol use problems.
Exclusion Criteria:
- Persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: In-Person Motivational Interviewing
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.
|
This is a counseling intervention to support behavior change conducted in-person (face-to-face) between the investigator and the participant.
|
Experimental: Mobile MI
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.
|
This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant
|
No Intervention: Waitlist Control
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..
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) from baseline to one (1) month.
Time Frame: 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.
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1 and 6 months
|
The investigators compared the change in AUDIT and AUDIT-C alcohol use scores over time moderated by HIV status.
|
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.
Time Frame: 6 months
|
The investigators compared the change in AUDIT alcohol use scores over time moderated by ASEBA mental health diagnoses.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Valerie Harder, PhD, University of Vermont
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 30, 2014
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
June 1, 2018
First Submitted That Met QC Criteria
June 18, 2018
First Posted (Actual)
June 29, 2018
Study Record Updates
Last Update Posted (Actual)
June 29, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRBSS 14-188
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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