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

August 31, 2023 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Lesotho
      • Mokhotlong, Lesotho
        • Not yet recruiting
        • Mapholaneng Health Center
        • Contact:
          • Mosa Tlahali
      • Mokhotlong, Lesotho
        • Not yet recruiting
        • St. James Health Center
        • Contact:
          • Mrs. Marorisang
    • Butha Buthe
      • Butha-Buthe, Butha Buthe, Lesotho
        • Recruiting
        • Butha Buthe District Hospital
        • Contact:
          • Thabo Mokhothu, MD
      • Butha-Buthe, Butha Buthe, Lesotho
        • Not yet recruiting
        • Seboche Hospital
        • Contact:
          • Callextina Maepa
      • Butha-Buthe, Butha Buthe, Lesotho
        • Not yet recruiting
        • St. Paul's Health Centre
        • Contact:
          • Benedicta Qhasho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mhGAP-Remote
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
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.
Active Comparator: mhGAP-Standard
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
Four in-person sessions with up to two booster sessions following the principles of World Health Organization's Mental Health Gap Action Programme (mhGAP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported alcohol use
Time Frame: 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.
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
Time Frame: 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.
Change from baseline to approximately 20-weeks [range >16--28 weeks] and 32-weeks follow-up [range >28--40 weeks]
Biomarker phosphatidylethanol (PEth)
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]
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]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV viral load
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]
For patients with HIV, number of copies of HIV per millimeter 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]
Liver function
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]
Aspartate Aminotransferase and Alanine Aminotransferase in whole blood
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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

SolidarMed

Investigators

  • Principal Investigator: Jennifer M. Belus, PhD, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-2023
  • U1111-1292-9288 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

The data can be accessed by the public, through creation of an account with Open Science Foundation, an open-access data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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