Condition category
Mental and Behavioural Disorders
Date applied
04/02/2011
Date assigned
01/04/2011
Last edited
21/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.kcl.ac.uk/index.aspx

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24725468

Publication citations

  1. 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.

Additional files

Editorial Notes