Substituting SMSs for Provider-delivered Care to Improve Alcohol Use Outcomes
2 other identifiers
interventional
255
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
August 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2025
CompletedFebruary 20, 2025
February 1, 2025
8 months
June 21, 2023
February 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Self-reported alcohol use
Change from baseline to approximately 20-weeks [range >16--28 weeks] and 32-weeks follow-up [range >28--40 weeks]
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]
Other Outcomes (2)
HIV viral load
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
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]
Study Arms (2)
mhGAP-Remote
EXPERIMENTALmhGAP-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.
mhGAP-Standard
ACTIVE COMPARATORmhGAP-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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Basel, Switzerlandlead
- SolidarMedcollaborator
Study Sites (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
Related Publications (5)
Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055.
PMID: 24700332BACKGROUNDHahn JA, Dobkin LM, Mayanja B, Emenyonu NI, Kigozi IM, Shiboski S, Bangsberg DR, Gnann H, Weinmann W, Wurst FM. Phosphatidylethanol (PEth) as a biomarker of alcohol consumption in HIV-positive patients in sub-Saharan Africa. Alcohol Clin Exp Res. 2012 May;36(5):854-62. doi: 10.1111/j.1530-0277.2011.01669.x. Epub 2011 Dec 7.
PMID: 22150449BACKGROUNDmhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP). Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138690/
PMID: 23741783BACKGROUNDAtkins DL, Cumbe VFJ, Muanido A, Manaca N, Fumo H, Chiruca P, Hicks L, Wagenaar BH. Validity and item response theory properties of the Alcohol Use Disorders Identification Test for primary care alcohol use screening in Mozambique (AUDIT-MZ). J Subst Abuse Treat. 2021 Aug;127:108441. doi: 10.1016/j.jsat.2021.108441. Epub 2021 Apr 28.
PMID: 34134876BACKGROUNDBelus JM, Johnson NE, Yoon GH, Tschumi N, Lerotholi M, Falgas-Bague I, Lee TT, Letsoela P, Magidson JF, Amstutz A, Labhardt ND. SMSs as an alternative to provider-delivered care for unhealthy alcohol use: study protocol for Leseli, an open-label randomised controlled trial of mhGAP-Remote vs mhGAP-Standard in Lesotho. Trials. 2024 Sep 2;25(1):575. doi: 10.1186/s13063-024-08411-3.
PMID: 39223600DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer M. Belus, PhD
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2023
First Posted
June 29, 2023
Study Start
August 11, 2023
Primary Completion
April 10, 2024
Study Completion
January 14, 2025
Last Updated
February 20, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.