Coordinated care for alcohol problems in Goa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this parallel-group randomized trial, adults with AUDIT scores indicating problem drinking in Goa are randomly assigned to receive CCAP plus enhanced usual care or enhanced usual care alone. The primary outcome is the percentage of days abstinent at three months, with secondary outcomes including days abstinent at six and 12 months, heavy drinking days, drinking intensity, remission, and related harms. The study uses stratified randomization by baseline severity and follows participants for up to 12 months to assess effectiveness and cost-effectiveness. The intervention combines a psychosocial, digital, and coordinated care approach delivered through primary and community healthcare centers in Goa. Eligible participants must reside in Goa, have access to suitable language options, and, for certain severities, meet mobile access or home-visit requirements as applicable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Scoring positive for problem drinking (≥ 8 on the AUDIT)
2. Have been residing in Goa for more than 12 continuous preceding months as an indicator of stability of residence which would be required both for treatment delivery and completion of outcome evaluation.
3. Language:

   1. For hazardous drinking (AUDIT score of 8-15), patients must be able to understand at least one of the local vernacular languages (Hindi or Konkani) or English. Patients must be able to read at least one of the local vernacular languages (Hindi or Marathi) or English.
   2. For harmful and dependent drinking (AUDIT score of \>15), patients must be able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
4. For hazardous drinking, patients must also have access to a personal smartphone with WhatsApp.
5. For dependent drinking (AUDIT score of \>19), patients must consent for home visits and must also be eligible for home detoxification as per structured detoxification protocol.

Exclusion Criteria:

1. For hazardous drinking, patients with significant visual or hearing impairment will be ineligible due to the audio-visual nature of the intervention.
2. For harmful and dependent drinking, patients with significant speech, hearing, or language impairment (as evident during screening) will be excluded as the intervention is primarily a 'talking treatment'.
3. For patients who present to the PHC/CHC needing urgent medical attention (emergency treatment or in-patient admission), screening will be deferred until their condition is stable.
4. Those who are alcohol dependent and do not meet the eligibility criteria for home detoxification as per protocol.
5. Those who are alcohol dependent but are currently not drinking. As AUDIT covers a period of 12 months, it will also detect those who meet the criteria for alcohol dependence over the past 12 months but are currently abstinent (hence not eligible for detoxification).

Where it's running

• Sangath
  Goa, India Recruiting

Study contacts

• Study coordinator: Abhijit Nadkarni
• Email: abhijit.nadkarni@lshtm.ac.uk
• Phone: +91 7887872345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.