Back to results

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

Primary Purpose

Alcohol Use Disorder, Mild, Alcohol Use Disorder, Moderate

Status

Recruiting

Phase

Not Applicable

Locations

Lesotho

Study Type

Interventional

Intervention

mhGAP-Remote

mhGAP-Standard

About this trial

This is an interventional treatment trial for Alcohol Use Disorder, Mild focused on measuring SMSs, alcohol use, Mental Health Gap Action Programme (mhGAP), Lesotho

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Butha Buthe District HospitalRecruiting
Seboche Hospital
St. Paul's Health Centre
Mapholaneng Health Center
St. James Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mhGAP-Remote

mhGAP-Standard

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-reported alcohol use

Self-report using the Alcohol Use Disorder Identification Test (AUDIT). Higher scores indicate more alcohol use and associated problems.

Secondary Outcome Measures

Self-reported alcohol use

Self-report using the Alcohol Use Disorder Identification Test (AUDIT). Higher scores indicate more alcohol use and associated problems.

Biomarker phosphatidylethanol (PEth)

PEth concentration in dried blood spots

Full Information

NCT ID

NCT05925270

First Posted

June 21, 2023

Last Updated

August 31, 2023

Sponsor

University Hospital, Basel, Switzerland

Collaborators

SolidarMed

1. Study Identification

Unique Protocol Identification Number

NCT05925270

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 11, 2023 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

SolidarMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder, Mild, Alcohol Use Disorder, Moderate

Keywords

SMSs, alcohol use, Mental Health Gap Action Programme (mhGAP), Lesotho

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mhGAP-Remote

Arm Type

Experimental

Arm Description

Arm Title

mhGAP-Standard

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

mhGAP-Remote

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

mhGAP-Standard

Intervention Description

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 Outcome Measure Information:

Title

Self-reported alcohol use

Description

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]

Secondary Outcome Measure Information:

Title

Self-reported alcohol use

Description

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]

Title

Biomarker phosphatidylethanol (PEth)

Description

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]

Other Pre-specified Outcome Measures:

Title

HIV viral load

Description

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]

Title

Liver function

Description

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]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mokhali Mokhu, BA

Phone

+26658540346

m.mokhu@solidarmed.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Malebanye Lerotholi, MPH

Phone

+26659669655

malebanye.lerotholi@unibas.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer M. Belus, PhD

Organizational Affiliation

University Hospital, Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Butha Buthe District Hospital

City

Butha-Buthe

State/Province

Butha Buthe

Country

Lesotho

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thabo Mokhothu, MD

Facility Name

Seboche Hospital

City

Butha-Buthe

State/Province

Butha Buthe

Country

Lesotho

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Callextina Maepa

Facility Name

St. Paul's Health Centre

City

Butha-Buthe

State/Province

Butha Buthe

Country

Lesotho

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benedicta Qhasho

Facility Name

Mapholaneng Health Center

City

Mokhotlong

Country

Lesotho

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mosa Tlahali

Facility Name

St. James Health Center

City

Mokhotlong

Country

Lesotho

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mrs. Marorisang

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://osf.io/ftqyd/

Citations:

PubMed Identifier

24700332

Citation

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. Erratum In: Am J Psychiatry. 2014 Dec 1;171(12):1338.

Results Reference

background

PubMed Identifier

22150449

Citation

Hahn 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.

Results Reference

background

PubMed Identifier

23741783

Citation

mhGAP 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/

Results Reference

background

PubMed Identifier

34134876

Citation

Atkins 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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs