Clinical trial NCT05925270: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder, Mild
Alcohol Use Disorder, Moderate
Keywords: SMSs
alcohol use
Mental Health Gap Action Programme (mhGAP)
Lesotho
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: SolidarMed
First posted: 2023-06-29
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported alcohol use
timeFrame: Change from baseline to approximately 8-weeks follow-up [range 6--16 weeks]
Secondary outcomes:
measure: Self-reported alcohol use
timeFrame: Change from baseline to approximately 20-weeks [range >16--28 weeks] and 32-weeks follow-up [range >28--40 weeks]
measure: Biomarker phosphatidylethanol (PEth)
timeFrame: 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:
measure: HIV viral load
timeFrame: 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]
measure: Liver function
timeFrame: 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]
Locations:
city: Butha-Buthe
country: Lesotho
facility: Butha Buthe District Hospital
state: Butha Buthe
city: Butha-Buthe
country: Lesotho
facility: Seboche Hospital
state: Butha Buthe
city: Butha-Buthe
country: Lesotho
facility: St. Paul's Health Centre
state: Butha Buthe
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jennifer M. Belus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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/
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.