An interventional study of mhGAP-Remote and mhGAP-Standard in Alcohol Use Disorder, Mild and Alcohol Use Disorder, Moderate, sponsored by University Hospital, Basel, Switzerland. Completed at 3 sites in Lesotho. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 255 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Four in-person sessions with up to two booster sessions following the principles of World Health Organization's Mental Health Gap Action Programme (mhGAP).
Self-reported alcohol use
Self-report using the Alcohol Use Disorder Identification Test (AUDIT). Higher scores indicate more alcohol use and associated problems.
Time frame: Change from baseline to approximately 8-weeks follow-up [range 6--16 weeks]
Self-reported alcohol use
Self-report using the Alcohol Use Disorder Identification Test (AUDIT). Higher scores indicate more alcohol use and associated problems.
Time frame: 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
Time frame: 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]
HIV viral load
For patients with HIV, number of copies of HIV per millimeter in dried blood spots
Time frame: 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]
Liver function
Aspartate Aminotransferase and Alanine Aminotransferase in whole blood
Time frame: 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]
Plan to share: Yes — The relevant anonymized data and statistical code will be deposited alongside the published peer-reviewed papers, in alignment with data sharing and verification procedures. Other investigators wishing to access the data for additional analyses can contact the study PI so that the appropriate documents (e.g., data sharing, ethics approvals) can be arranged.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: A de-identified dataset will be deposited in an open-access data repository at the end of the project and once the objectives specified in the protocol have been addressed.
Access criteria: The data can be accessed by the public, through creation of an account with Open Science Foundation, an open-access data repository.
Data sharing details ↗ · osf.io
Ran from Aug 2023 to primary completion in Apr 2024, 7 months.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's 7 months is below that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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