Alcohol Use Disorders- Mobile Based Brief Intervention Treatment (AMBIT): A Pilot RCT
Condition: Hazardous Drinking
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The World Health Organization (WHO) defines three levels of problematic alcohol use;
      hazardous drinking (HD) (which puts a person at risk of developing health/social problems),
      harmful drinking (where health/social problems are already occurring), and alcohol dependence
      (where serious problems have already occurred). Although HD and harmful drinking affects a
      larger proportion of the population (and causes many more problems) than alcohol dependence,
      Indian health policy focuses mainly on institutional delivery of care for alcohol dependence.
      Extensive evidence globally demonstrates the effectiveness of Brief Interventions (BIs) in
      reducing drinking in HD. However, in India, barriers to providing such treatments are the
      inequitable distribution of trained healthcare professionals and concerns about the cultural
      generalisability of interventions developed in the West. Mobile phone technology like SMS
      (Short Messaging Service) and interactive voice response (IVR) can deliver BIs to large
      numbers of HDs, quickly and at low cost, as demonstrated in smoking cessation interventions.
      Furthermore, a growing body of evidence demonstrates that following a systematic methodology
      to culturally adapt psychosocial interventions increases acceptability by recipients and
      delivery agents, and feasibility of delivery. The overall objective of AMBIT is to develop a
      contextually appropriate BI for HD that can be delivered using mobile phone technology to
      overcome barriers to access in low resource settings.

      Preliminary formative research has informed the development of the first version of the
      treatment package, which was tested through a case series, by refining the intervention
      content and delivery through an iterative process, to develop the final intervention. This
      pilot Randomised Control Trial (RCT) will aim to empirically evaluate the feasibility and
      acceptability, as well as preliminary impact of the BI, and fine-tune the procedures for a
      definitive RCT. It therefore does not have clear hypotheses, but instead different primary
      objectives, which are listed in the following.

      OBJECTIVES

        1. To assess the feasibility of delivering the mobile-based BI.

        2. To assess the acceptability of delivering the mobile-based BI.

        3. To inform sample size calculation (based on preliminary estimate of effectiveness) and
           refine procedures for a definitive RCT.

        4. To refine the mobile-based BI package for a definitive RCT.

        5. To assess the impact of the mobile-based BI, on treatment outcomes.
    

Detailed description: 
      The AMBIT study is aimed at developing and evaluating a mobile based BI for hazardous
      drinkers in Goa-India. The first version of the treatment package was developed through
      formative research, and tested through a case series, to develop the final intervention. This
      pilot Randomised Control Trial (RCT) will aim to empirically evaluate the feasibility,
      acceptability and preliminary impact of the BI, and fine-tune the procedures for a definitive
      RCT. This protocol will serve as a research framework for the implementation of the proposed
      pilot RCT.

      OBJECTIVES

        1. To assess the feasibility of delivering the mobile-based BI.

        2. To assess the acceptability of delivering the mobile-based BI.

        3. To inform sample size calculation (based on preliminary estimate of effectiveness) and
           refine procedures for a definitive RCT.

        4. To refine the mobile-based BI package for a definitive RCT.

        5. To assess the impact of the mobile-based BI, on treatment outcomes. METHODS Study
           sample- A sample of 120 participants will be recruited; approximately evenly spread out
           across all study settings and interventions. The sample size is not based on formal
           power calculations as the study is not designed to test a hypothesis. The sample size
           estimations have been made based on our previous experiences of pilot RCTs and deemed
           sufficient to achieve the goals of understanding the acceptability, feasibility, and
           preliminary impact of an intervention.

      Recruitment Procedure- In all three settings, researchers, who will identify hazardous
      drinkers through appropriate screening procedures. Eligible participants will be invited to
      join the study if they provide voluntary consent to participate.

      In educational institutions and workplaces: At educational institutions and workplaces
      participant recruitment will be nested within the health and wellness camp (previously tested
      during the formative research phase), that includes screening for two other health-related
      issues (Perceived Stress and Physical Activity) aside from AUD screening. This is done to
      overcome resistance to entering screening for an alcohol-related program, due to cultural
      stigma around alcohol consumption. It is expected that by introducing screening for a range
      of health issues, this issue will be mitigated.

      In PHCs: The researchers will perform universal screening.

      Recruitment will also be done through referrals from the following sources:

        -  Self: Potential participants will learn about our program through advertising (e.g.
           banners, posters and leaflets) and then approach a researcher for screening.

        -  Gatekeepers: (e.g. At Colleges: Faculty/Students; At workplaces: Human Resource [HR]
           officials/peers; At PHC's: Medical officers and PHC staff): The researchers will seek
           assistance from these gatekeepers to build awareness about the project, and refer
           potential participants to the researchers.

      Screening tools: All participants will be screened using the AUDIT to identify hazardous
      drinking (Saunders, 1993). Other tools that will be used as part of the 'Health and Wellness
      Camp' will include the International Physical Activity Questionnaire (IPAQ) (Booth, 2000),
      and Perceived Stress Scale (PSS) (Cohen, Kamarck, & Mermelstein, 1983).

      AUDIT is a 10 item screening tool developed by the World Health Organisation (WHO) for the
      detection of AUD. It has been validated in India (Pal et al., 2004), used in cross-national
      studies, and used in the study setting (Nadkarni, 2017). For a previous study, the AUDIT has
      been translated into Konkani (Goan vernacular), using a systematic translation-back
      translation method with two teams of translators, followed by an item-by item analysis and
      selection by consensus (Silva et al., 2003). The AUDIT is used to identify AUDs and
      categorise it into hazardous drinking (score of 8-15), harmful drinking (16-19) and dependent
      drinking (>20) The Perceived Stress Scale (PSS) is a widely used instrument for measuring
      perception of stress. It has been empirically validated (Lee et al, 2012) with college
      students and workers and translated into 25 languages.

      The International Physical Activity Questionnaire (IPAQ) is widely used to measure health
      related physical activity, and has acceptable measurement properties for use in many settings
      and in different languages, and is suitable for use among young and middle-aged adults (15-69
      years).(Lee et al, 2011)

      Consenting procedures:

      All eligible participants will be informed about the study, taken through the informed
      consent process and requested to provide written consent to participate. The researcher will
      ensure that any queries about the intervention are resolved. All consent procedures will be
      audio-recorded with the permission of the participant.

      Sampling Procedure- Stratified randomisation will be used. Consenting eligible participants
      will be stratified into three strata, based on the recruitment site- educational
      institutions, workplaces and PHCs. Consenting participants from each stratum will be
      randomized to receive our intervention (AMBIT), face-to-face BI or active control. An
      independent data manager will generate a randomisation list and participants will be
      randomised using Sequentially Numbered Opaque Sealed Envelopes to maximise allocation
      concealment.

      Baseline assessments

      Baseline measures administered to consenting participants include:

        1. Data about potential confounders through a socio-demographic form, such as age, gender,
           employment status, educational status, and marital status. In addition, we will collect
           information required for the delivery of the intervention such as preferred days/time to
           receive the SMS/IVR, preference for SMS and/or IVR (For the participants receiving the
           mobile-based intervention)

        2. TLFB (Time Line Follow Back method): The TLFB is a calendar method of collecting data
           about quantity and frequency of drinking. The TLFB has high test-retest reliability and
           concurrent validity has been established in various types of AUD. The TLFB has been used
           in previous research at the study site (Nadkarni, 2017).

      Outcome Assessment:

      Adding to the primary and secondary outcomes mentioned in other parts of this registration,
      process indicators will be collected. These include the following:

        -  Number of participants screened for AUDs in each setting

        -  Number and proportion of participants screened positive for HD on AUDIT

        -  Number and proportion of participants consenting for the treatment

        -  Number and proportion of dropouts during the 8 week treatment (Dropouts are defined as
           participants choosing to stop receiving the intervention messages)

        -  Reasons for refusal to participate

        -  Reasons for drop-out

        -  Proportion of participants choosing SMS vs IVR vs both

        -  Proportion of participants that listen to the complete IVR

        -  Proportion of participants with high engagement (defined as response to more than 50% of
           messages).

        -  Number and proportion of participants completing outcome assessment Nested qualitative
           study- Qualitative outcome interviews will also be conducted with a sub-sample of
           participants after outcome assessment to gain insight into the impact of the
           mobile-based BI on the hazardous drinker. We will purposively select treatment
           completers and drop-outs, those who reduce drinking and those who do not, to understand
           their perceptions of the treatment and suggestions to improve the intervention. An
           interview guide will be developed which focuses on understanding acceptability,
           feasibility and perceived impact of the mobile based BI.

      Monitoring and follow up:

      Study researchers will submit a daily log on the challenges faced in recruitment at each site
      to the project coordinator during recruitment. Researchers will also send information on the
      number of participants recruited each day to the project data manager as per the daily case
      reporting form. The coordinator will provide daily supervision via phone call, review the
      daily logs and visit each site weekly. Any challenges will be addressed by the Project
      Coordinator over the course of the study.

      As soon as a participant is recruited to the mobile-based BI, contact information (excluding
      name) along with relevant details such as treatment preferences will be shared with VIAMO's
      project manager. The project data manager will be responsible to upload participant details
      on VIAMO's platform within 24 hours post-recruitment. Upon receiving study participant
      details through the VIAMO platform, VIAMO's project manager will be responsible to initiate
      mobile based intervention with participants no later than 48 hours upon receiving participant
      details. Accordingly, every participant will receive the mobile based BI for 8 weeks. The
      data manager and program coordinator will monitor the delivery of the intervention for each
      participant and export data from the VIAMO platform on a weekly basis.

      Data transfer and storage:

      oBaseline and outcome data will be collected by the Researcher using the tablet devices which
      will have pre-programmed check rules. The treatment data will be exported via the VIAMO
      platform as an excel file on a weekly basis.

      oAll data from the VIAMO platform and tablet data will be downloaded weekly on a dedicated
      computer with internet connection and updated antivirus software.

      oCSV data files will be downloaded by site and merged using a CSV file merge utility.

      oThe merged file will be saved in a folder (categorised by the week) and backed up on to the
      server. The weekly file will be additionally backed up on an external hard drive as an
      additional safety measure.

      oThe Data Manager will be responsible for counting and checking the forms received from the
      sites.

      oA log of missing forms or incomplete data (if any) will be reported to the concerned
      researcher by the Data Manager and the same will be received within two working days.

      oVerified paper forms will be entered into STAR software system running on desktops or on an
      excel spreadsheet.

      oAll CSV files will be converted into Excel/SPSS/Stata file format.

      Data Storage:

      Participant details and confidential information collected on the consent form will be safely
      stored in a cupboard, which will be locked and the keys will be in the custody of the Data
      Manager. Secure transfer of the forms from the data team to outcome evaluations team will be
      done by the data entry assistant.

      Data analysis:

      Quantitative- Baseline characteristics of individuals who consented and did not consent, and
      participants who did and did not complete outcome assessments, as will baseline
      characteristics of participants in the intervention arms versus those in the control arm,
      will be presented as proportions or means. The process indicators will be presented
      consistent with CONSORT guidelines (Moher et al, 2001) including a trial flow chart. The
      primary analysis will be intention-to-treat at the 2 month end-point regardless of treatment
      adherence, adjusted for baseline AUDIT. Regression analysis will be conducted for the
      treatment outcomes. Effect sizes will be reported as mean differences and standardised mean
      differences with 95% confidence intervals for continuous outcomes.

      Qualitative- Thematic analysis will be used to analyse the qualitative data from the outcome
      interviews, using Nvivo version 11. Analysis will involve generation of codes from raw data.
      Themes will be derived by retrieving pieces of data pertaining to codes and by examining
      their meaning in relation to the research questions (acceptability of the content and
      delivery of the mobile-based BI, engagement barriers, impact on drinking).

      OUTPUT At the end of the pilot RCT, data obtained will be used to frame a contextually
      adapted BI for HD that can be further tested for cost effectiveness in a definitive RCT. The
      learnings from the pilot RCT will be synthesised to refine procedures for a definitive RCT
      and the preliminary understanding of effect sizes will be used to plan sample size for a
      subsequent definitive RCT.
    

Intervention name(s): AMBIT (Alcohol use disorders- mobile based Brief Intervention treatment) intervention; Face to face Brief Intervention; BI leaflet intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The intervention will consist of participants receiving messages and/IVR calls not more than twice or thrice a week on their mobile phone for a duration of 8 weeks. Messages/IVR calls will be sent through VIAMO's technology platform. Each week messages will be focussed on specific content areas derived from the formative research of the study. Some of the components of the intervention include:
Self awareness messages
Self reflection messages
Motivational messages
Messages on safe drinking, alcohol reduction, drinking management, risk management, craving management and drinking alternatives.
Health education messages
Personalized feedback and information
Help-seeking resources
Goal setting messages; The intervention will consist of the participants receiving the BI based on the WHO Mental Health Gap Action Programme (mhGAP) intervention from a trained researcher. The BI will be conducted over a single session (5-10 mins).; The intervention will consist of an educational BI leaflet consisting of health information on alcohol consumption, and tips to manage and reduce drinking.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a parallel three-arm single blind individually randomised controlled trial, with a nested qualitative study.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hazardous Drinking, mHealth, India, Brief intervention