NCT05925270Completed
Substituting SMSs for Provider-delivered Care to Improve Alcohol Use Outcomes
Substituting SMSs for Provider-delivered Care to Improve Alcohol Use Outcomes in People With and Without HIV in Lesotho
Source: ClinicalTrials.gov · Last updated 20 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 255 (actual)
- First submitted
- 21 Jun 2023
- Start date
- 11 Aug 2023
- Primary completion date
- 10 Apr 2024
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- HIV
- NCT number
- NCT05925270
What you commit to
- Study type: Interventional
- Participants enrolled: 255
- From 11 Aug 2023 to the primary completion date, 10 Apr 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving psychological treatment for alcohol use
Other illness
- 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
Other
- High-risk alcohol use that warrants medical management
- Reported pregnancy at time of enrolment
- Participation in another trial that is judged by the site investigator as non-compatible with this study
- Unable to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Butha Buthe District Hospital Coordinator of this site? Confirm its status | Butha-Buthe | Lesotho | Unknown status |
| Seboche Hospital Coordinator of this site? Confirm its status | Butha-Buthe | Lesotho | Unknown status |
| St. Paul's Health Centre Coordinator of this site? Confirm its status | Butha-Buthe | Lesotho | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.