Contact information
Type
Scientific
Primary contact
Prof John Strang
ORCID ID
Contact details
Addictions Department
National Addiction Centre
Institute of Psychiatry
Addiction Sciences Building
4 Windsor Walk
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0819
john.strang@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NIHR CSP ref.: 52665
Study information
Scientific title
Cluster randomised controlled trial of contingency management targeting increased completion of hepatitis B (Hep B) vaccination amongst people in treatment for heroin dependence
Acronym
CONMAN hep B
Study hypothesis
The use of incentives will increase the take-up and completion of Hep B vaccination when compared to a control condition (TAU) in which no incentives are offered.
The formal null hypothesis is that: there will be no difference in take-up and completion between groups of patients offered or not offered incentives.
Ethics approval
North London REC 2, 27/09/2010, ref: 10/HO724/56
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Addiction opiate dependence
Intervention
In accordance with best clinical practice all sites will offer patients the 'super-accelerated vaccination schedule' (comprising three injections at 1, 7 and 21 days) (Department of Health, 2006; 2007). The vaccination schedule offered in each site will be identical. The treatment offered will differ only in terms of the absence/presence (and type) of adjunctive incentive schedule as follows:
Group A (Experimental Group):
Vaccination with fixed incentive schedule (CM-fixed): Service-users receive up to an aggregate total of £30 comprising in vouchers comprising 3 x £10 vouchers given at each of 3 vaccination injections (days 1, 7 and 21).
Group B (Experimental Group):
Vaccination with escalating incentive schedule (CM-escalating): Service-users receive up to an aggregate total of £30 in vouchers which escalate in value at each of the 3 successive vaccination injections (i.e. £5, £10 and £15 vouchers at days 1, 7 and 21 respectively).
Group C (Control Group):
Vaccination without incentive.
The hepatitis B vaccine should be delivered in line with existing service protocols at all sites. Delivery of the incentive will be complimented by appropriate positive verbal reinforcement to the patient which emphasises the positive benefits of the vaccination, provides appreciative feedback for their attendance at the appointment and recognition that the patient has taken a positive step in attending for treatment and complying with appointment times.
Intervention type
Drug
Phase
Not Applicable
Drug names
Hepatitis B (Hep B) vaccination
Primary outcome measure
Successful completion of the three Hep B vaccination injections (days 1, 7 and 21) within 28 days. Participants will be defined as completers if they receive all three injections by day 28.
Secondary outcome measures
1. On-time attendance
2. For those who do not complete, the proportion of vaccination doses received
Overall trial start date
14/02/2011
Overall trial end date
31/07/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 18 years, either sex
2. New episode of opiate treatment (within first 2 months)
3. Previous, current, or at risk of engaging in risk behaviour (i.e. injecting drug use)
4. Willing to receive vaccination
5. Willing to provide informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n = 192 (total); 64 per trial intervention
Participant exclusion criteria
1. Pregnant or breastfeeding
2. Received prior hepatitis B vaccination course
3. Current or past hepatitis B infection
Recruitment start date
14/02/2011
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addictions Department
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
South London & Maudsley NHS Foundation Trust and Kings College London (UK)
Sponsor details
c/o Jenny Liebscher
SLaM R&D Office
Room W 1.08
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0251
jenny.liebscher@kcl.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0707-10149)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24725468
Publication citations
-
Results
Weaver T, Metrebian N, Hellier J, Pilling S, Charles V, Little N, Poovendran D, Mitcheson L, Ryan F, Bowden-Jones O, Dunn J, Glasper A, Finch E, Strang J, Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial., Lancet, 2014, 384, 9938, 153-163, doi: 10.1016/S0140-6736(14)60196-3.