Substituting SMSs for Provider-delivered Care to Improve Alcohol Use Outcomes in People With and Without HIV in Lesotho
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 3
- 主要终点
- Self-reported alcohol use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: mhGAP-Remote (Behavioral)
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.
干预措施: mhGAP-Standard (Behavioral)
结局指标
主要结局
Self-reported alcohol use
时间窗: 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.
次要结局
- Self-reported alcohol use(Change from baseline to approximately 20-weeks [range >16--28 weeks] and 32-weeks follow-up [range >28--40 weeks])
- 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])