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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05925270

Collaborator

SolidarMed (Other)

248

Enrollment

Locations

Arms

17.1

Anticipated Duration (Months)

49.6

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder, Mild Alcohol Use Disorder, Moderate	Behavioral: mhGAP-Remote Behavioral: mhGAP-Standard	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

248 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Self-reported alcohol use [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 Outcome Measures

Self-reported alcohol use [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.
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]]
PEth concentration in dried blood spots

Other Outcome Measures

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]]
For patients with HIV, number of copies of HIV per millimeter in dried blood spots
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]]
Aspartate Aminotransferase and Alanine Aminotransferase in whole blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Butha Buthe District Hospital	Butha-Buthe	Butha Buthe	Lesotho
2	Seboche Hospital	Butha-Buthe	Butha Buthe	Lesotho
3	St. Paul's Health Centre	Butha-Buthe	Butha Buthe	Lesotho
4	Mokhotlong District Hospital	Mokhotlong		Lesotho
5	St. James Health Center	Mokhotlong		Lesotho