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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Substituting SMSs for Provider-delivered Care to Improve Alcohol Use Outcomes in People With and Without HIV in Lesotho

Conditions
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Alcohol Use Disorder, Mild, Alcohol Use Disorder, Moderate

Intervention / Treatment
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* Behavioral: mhGAP-Remote
* Behavioral: mhGAP-Standard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mhGAP-Remote<br>mhGAP-Remote was developed specifically by our team. It involves the same intervention components described in mhGAP-Standard. However, in mhGAP-Remote the intervention is delivered mostly through standardized SMSs. There is one in-person session with the interventionist, where the participant learns the core skills of mhGAP. This is followed by standardized SMSs to reinforce intervention content learned in the first session. Study interventionists will be able to provide brief telephonic support to participants if participants struggle to implement the skills learned. | Behavioral: mhGAP-Remote<br>* One in-person session followed by standardized SMSs to reinforce the concepts learned in the first session. The intervention follows principles of the World Health Organization's Mental Health Gap Action Programme (mhGAP). Study interventionists can provide telephonic support to participants to implement the skills.<br>|
| Active Comparator: mhGAP-Standard<br>mhGAP-Standard refers to the existing evidence-based intervention guide that was developed by the WHO to help non-specialist providers in LMIC settings provide treatment for alcohol use, among other mental health and neurological conditions. For the current study, the intervention will focus on mhGAP's psychosocial interventions, which involve psychoeducation, brief motivational interviewing, and providing strategies to reduce and/or stop use. The intervention uses a harm reduction approach, meaning that participants do not need to stop using alcohol altogether. Interventionists will deliver 4 sessions, approximately 45-60 mins each, to participants in person. Sessions are designed to be delivered approximately weekly. Providers have the option to deliver up to 2 additional booster sessions to participants who may benefit from additional care. | Behavioral: mhGAP-Standard<br>* Four in-person sessions with up to two booster sessions following the principles of World Health Organization's Mental Health Gap Action Programme (mhGAP).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMSs, alcohol use, Mental Health Gap Action Programme (mhGAP), Lesotho