Condition category
Infections and Infestations
Date applied
14/03/2014
Date assigned
06/05/2014
Last edited
24/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Mobile digital X-ray screening for tuberculosis (TB) - a London initiative called 'Find&Treat' - has been shown to be highly clinically and cost-effective in tackling TB in hard-to-reach groups (homeless people, substance misusers and prisoners). However, the overall impact of the intervention is dependent on achieving a high rate of uptake. This presents unique challenges among this population who are often hard to engage. Our preliminary work has shown that use of financial incentives is operationally problematic in this population but trained peer educators, who have direct experience of TB with homeless and / or drug and alcohol addiction, are potentially a valuable health promotion resource and can educate and motivate hard to reach groups to take up the offer of voluntary screening. There is a cost to the use of peer educators and therefore a need to formally evaluate effectiveness. Currently normal practice is to rely on staff from the Mobile X-ray Unit (MXU) to liaise with homeless sector staff to promote uptake which results in about 50% of residents accepting screening. The study aims to determine the effect of peer educator on uptake of MXU screening.

Who can participate?
This is a hostel centred health promotion project, thus residential homeless hostels within London being offered NHS-led mobile X-ray screening for TB are eligible to participate. However, hostels with 80% or more uptake rate from previous screening are excluded.

What does the study involve?
Hostels were randomly allocated on a rolling basis to either the intervention (use of peer educator) or to the control arm (normal practice - use of MXU and hostel staff) by minimisation on using a text messaging randomisation service provided by Sealed Envelope (http://www.sealedenvelope.com). On the day of the screening: the study team observed the screening session and discreetly grade each hostel on the level of support provided by staff to maximise uptake. The hostels were scored on active participation of staff, staff level of awareness that screening is taking place, visible display of posters about screening in communal areas, and evidence that screening information was disseminated to residents prior to screening. Also noted was: overall level of participation of staff allocated to the screening, their efforts to engage with resident and promote uptake such as door knocking at residential hostels; peers were evaluated on their time keeping; external factors likely to influence uptake such as the weather, residents' accessibility to the location of the van, and if incentives were provided by the hostel.

What are the possible benefit and risks of participating?
Peer educators are appropriately trained and highly supported by Groundswell, a professional service user involvement organisation. We have found that their involvement appears not only to increase uptake of tuberculosis screening and heighten awareness of TB, but also has a positive effect on the uptake of other health interventions such as needle exchange and blood borne virus screening. We envisage the risk associated with this study is primarily related to the control arm not accessing peer education. However, there is insufficient evidence to justify the resource necessary to provide peer education to all settings screened.

Where is the study run from?
This TB Reach study has been set up by the Royal Free NHS Foundation Trust in collaboration with 'Find&Treat' under the University College London Hospitals NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
February 2012 to October 2013.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Andrew Hayward
a.hayward@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Hayward

ORCID ID

Contact details

Reader Infectious Disease Epidemiology
Research Department of Infection and Population Health
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7472 6777
a.hayward@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TB Reach Sub-Study 3 : RP-PG-0407-10340 : 10/H0302/51

Study information

Scientific title

Cluster randomised controlled trial of peer intervention on uptake of MXU screening for TB among hard-to-reach groups (homeless people and substance misusers).

Acronym

Study hypothesis

Using trained peer educators who have direct experience of TB with homelessness and/or substance misuse to educate and motivate hard-to-reach groups is a valuable health promotion resource to increase uptake of mobile digital radiography screening.

Ethics approval

Essex 2 NRES Committee East of England - Cambridge, 08/02/2011, ref: 10/H0302/51

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not applicable as this is a hostel centred study

Condition

Tuberculosis

Intervention

Random allocation of homeless residential hostels to either peer or MXU / hostel staff supported mobile digital X-ray TB screening of hard-to-reach groups.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Aggregate data comparing uptake of the offer of screening between intervention and control arm using the bed-list as the denominator.
1. Number of residents eligible for screening will be determined from hostels' records.
2. Number accepting screening will be determined from the MXU screening records.

Secondary outcome measures

Internal and external factors influencing screening such as the active participation of staff and peers, the weather, and the use of incentives by the participating hostel.

Overall trial start date

01/01/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Residents of participating homeless hostels within London who have not been screened in the 6 months prior to the scheduled MXU screening session.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2800 (1400 residents from 20 hostels in each arm) in London

Participant exclusion criteria

Residents of the participating homeless hostels who have been screened within 6 months of the scheduled MXU screening.

Recruitment start date

01/01/2012

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

c/o David Wilson
Sponsor's Representative
Joint Research Office
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)20 3447 5199
david.wilson@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) ref: NIHR PGFAR RP-PG-0407-10340

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26391630

Publication citations

Additional files

Editorial Notes