Contingency management targeting increased completion of hepatitis B (Hep B) vaccination amongst people in treatment for heroin dependence

ISRCTN	ISRCTN72794493
DOI	https://doi.org/10.1186/ISRCTN72794493
Secondary identifying numbers	NIHR CSP ref.: 52665

Submission date: 04/02/2011
Registration date: 01/04/2011
Last edited: 21/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Strang
Scientific

Addictions Department
National Addiction Centre
Institute of Psychiatry
Addiction Sciences Building
4 Windsor Walk
Denmark Hill
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0819
Email	john.strang@kcl.ac.uk

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	CONMAN hep B
Study objectives	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(s)	North London REC 2, 27/09/2010, ref: 10/HO724/56
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	14/02/2011
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	n = 192 (total); 64 per trial intervention
Key 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
Key exclusion criteria	1. Pregnant or breastfeeding 2. Received prior hepatitis B vaccination course 3. Current or past hepatitis B infection
Date of first enrolment	14/02/2011
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addictions Department

London
SE5 8AF
United Kingdom

Sponsor information

South London & Maudsley NHS Foundation Trust and Kings College London (UK)
Hospital/treatment centre

c/o Jenny Liebscher
SLaM R&D Office
Room W 1.08
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
England
United Kingdom

Phone	+44 (0)20 7848 0251
Email	jenny.liebscher@kcl.ac.uk
Website	http://www.kcl.ac.uk/index.aspx
"ROR"	https://ror.org/015803449

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0707-10149)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/07/2014		Yes	No