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Completed

NCT Number: NCT05925270

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

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.

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Key information

Conditions

Alcohol Use Disorder, Mild Alcohol Drinking Alcohol Use Disorder, Moderate Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butha Buthe District Hospital, Butha-Buthe, Lesotho

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mhGAP-Remote

Behavioral

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.

mhGAP-Standard

Behavioral

Four in-person sessions with up to two booster sessions following the principles of World Health Organization's Mental Health Gap Action Programme (mhGAP).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • SolidarMed

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 29, 2023
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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