The HIM (Health for Izhevsk Men) trial protocol.
BACKGROUND
Russia is one of the very few industrialised countries in the world where life expectancy has been declining. Alcohol has been implicated as a major contributor to the rapid fluctuations observed in male life expectancy since 1985 that have been particularly marked among working-age men. One approach to reducing the alcohol problem in Russia is 'brief interventions' which seek to change views of the personal acceptability of excessive drinking and to encourage self-directed behaviour change. There is limited understanding in Russia of the salience and applicability of Motivational Interviewing (MI), a well-defined brief intervention commonly used to target alcohol-related behaviour, but MI may have important potential for success within the Russian context.


METHODS
The study will be an individually randomised two-armed parallel group exploratory trial. The primary hypothesis is that a brief adaptation of MI will be effective in reducing self-reported hazardous drinking at 3 months. The secondary hypothesis is that it will be effective in reducing self-reported past week beverage alcohol consumption, alcohol dependence and related problems at 3 months and at 12 months. MI will also be effective at 12 months in reducing self-reported hazardous drinking, alcohol dependence and related problems, proxy reported hazardous drinking, and recent alcohol use as indicated by bio-markers. Participants are drawn from the Izhevsk Family Study II, with eligibility determined based on proxy reports of hazardous drinking in the past year. All participants undergo a health check, with MI subsequently delivered to those in the intervention arm. Signed consent is obtained from those in the intervention arm at this point. Both groups are then invited for 3 and 12 month follow ups. The control group will not receive any additional intervention.


BACKGROUND
ISRCTN82405938.
Tomkins
Susannah
S
Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. susannah.tomkins@lshtm.ac.uk
Allen
Elizabeth
E
Savenko
Olga
O
McCambridge
Jim
J
Saburova
Lyudmila
L
Kiryanov
Nikolay
N
Oralov
Alexey
A
Gil
Artyom
A
Leon
David A
DA
McKee
Martin
M
Elbourne
Diana
D
D000328:Adult; D000437:Alcoholism / Q000628:therapy*; D001521:Behavior Therapy / Q000941:ethics / Q000379:methods; D002985:Clinical Protocols; D004608:Eligibility Determination; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D054526:Men's Health; D008875:Middle Aged; D018579:Patient Selection; D012426:Russia