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 |
| Protocol serial number | NIHR CSP ref.: 52665 |
| Sponsor | South London & Maudsley NHS Foundation Trust and Kings College London (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0707-10149) |
- 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
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 |
|---|---|
| john.strang@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hepatitis B (Hep B) vaccination |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. On-time attendance |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 192 |
| 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
- United Kingdom
- England
Study participating centre
Addictions Department
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
