Substituting SMSs for Provider-delivered Care to Improve Alcohol Use Outcomes

Not Applicable

Completed

• Conditions: Alcohol Use Disorder, Mild; Alcohol Use Disorder, Moderate

• Registration Number: NCT05925270
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The goal of this clinical trial is to test whether a technology-substituted intervention (mhGAP-Remote) derived from the World Health Organization's (WHO) Mental Health Gap Action Programme-Intervention Guide (mhGAP-IG) is effective to reduce alcohol use among adults with and without HIV in Lesotho. Participants who receive the mhGAP-Remote intervention will complete one in-person intervention session pertaining to the mhGAP-IG module for alcohol use, followed by short message services (SMSs) related to the intervention material covered during the in person session. This will be compared to mhGAP-Standard, which involves 4 in-person sessions based on mhGAP-IG for alcohol use plus the option of 2 additional booster sessions. Participants in both treatment groups will complete assessments at baseline, 8-weeks follow-up, 20-weeks follow-up, and 32-weeks follow-up, consisting of self-reported questionnaires and laboratory tests.

Detailed Description

Mental health and alcohol and other drug use problems account for over 20% of the years lived with disability globally, including in low- and middle-income countries (LMICs). Unfortunately, there is a severe shortage of treatment providers available in LMICs for these problems, and access to care is limited due to cost, transportation, infrastructure, lack of awareness, and stigma. The use of technology as a substitute for some provider-delivered time is an appealing and promising strategy to increase access to alcohol use treatment. Specifically, using SMSs to deliver intervention content is a feasible approach in low-resource settings and has been successfully implemented for other behavioral health problems. The primary objective of this study is to test the effectiveness of a technology substituted mhGAP intervention, mhGAP-Remote, to reduce alcohol use when compared to standard in-person treatment, mhGAP-Standard. Study results can inform barriers to accessing treatment and care for alcohol use.

Study Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-06-29
• Study Start: 2023-08-11
• Primary Completion: 2024-04-10
• Study Completion: 2025-01-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• Adults (≥ 18 years old)
• Meets criteria for "hazardous drinking" according to the AUDIT (total score of ≥ 6 for women, ≥ 8 for men)
• Has cellphone access at least half the days of the week, regular access to electricity to charge the phone, and is comfortable receiving study-specific SMSs related to alcohol use treatment on the phone
• Willing to participate in a study focused on problem drinking
• Willing and able to regularly come to the health facility/clinic for intervention sessions during the active intervention period
• Able to read in Sesotho or English or has a treatment supporter (e.g., family member) able to read study-related materials
• Willing to have intervention sessions audio-recorded
• Attends one of the study clinics and intends to remain at the same clinic for the duration of the trial

Exclusion Criteria

• High-risk alcohol use that warrants medical management
• Known brain tumor or brain damage, history of epilepsy, or history of delirium
• Untreated major mental illness that interferes with study participation, such as psychosis, or mania
• Reported pregnancy at time of enrolment
• Currently receiving psychological treatment for alcohol use
• Participation in another trial that is judged by the site investigator as non-compatible with this study
• Unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported alcohol use	Change from baseline to approximately 8-weeks follow-up [range 6--16 weeks]	Self-report using the Alcohol Use Disorder Identification Test (AUDIT). Higher scores indicate more alcohol use and associated problems.

Secondary Outcome Measures

Name	Time	Method
Biomarker phosphatidylethanol (PEth)	Change from baseline to approximately 8-weeks [range 6--16 weeks], 20-weeks [range >16--28 weeks], and 32-weeks follow-up [range >28--40 weeks]	PEth concentration in dried blood spots
Self-reported alcohol use	Change from baseline to approximately 20-weeks [range >16--28 weeks] and 32-weeks follow-up [range >28--40 weeks]	Self-report using the Alcohol Use Disorder Identification Test (AUDIT). Higher scores indicate more alcohol use and associated problems.

Trial Locations

Locations (3)

Butha Buthe District Hospital; 🇱🇸 Butha-Buthe, Butha Buthe, Lesotho

Seboche Hospital; 🇱🇸 Butha-Buthe, Butha Buthe, Lesotho

St. Paul's Health Centre; 🇱🇸 Butha-Buthe, Butha Buthe, Lesotho