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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03573167
Other study ID # CHRBSS 14-188
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2014
Est. completion date December 31, 2015

Study information

Verified date June 2018
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 322
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
In-Person Motivational Interviewing (MI)
This is a counseling intervention to support behavior change conducted in-person (face-to-face) between the investigator and the participant.
Mobile Motivational Interviewing (MI)
This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Vermont Africa Mental Health Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. The investigators compared the change in AUDIT and AUDIT-C alcohol use scores over time moderated by HIV status. 1 and 6 months
Secondary 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. The investigators compared the change in AUDIT alcohol use scores over time moderated by ASEBA mental health diagnoses. 6 months
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