Award Title: PHaCT Trial: Preventing Homelessness, improving health for people leaving prison: a pilot randomised controlled trial of a Critical Time intervention
Funder: Chief Scientist Office, Scotland

Abstract: Background_x000D_
People leaving prison who are released back into the community are at a high risk of homelessness. Nearly 1 in 2 who are released do not have a settled home and 1 in 3 are homeless or are in unsettled housing one year later. The life expectancy of people without a stable home is much lower and they have a worse quality of life. There are also wider society impacts of homelessness such as lower community wellbeing, more crime and higher healthcare and justice costs. It has been estimated that on average the yearly cost of one case of rough sleeping could cost £20,128. Although there are good interventions to stop homelessness, they are mostly from the US and we do not know how these work for people with previous prison experience. Critical Time Intervention (CTI) is the name of a type of intervention which aims to support those most in need in society during times of important life changes. They help people at risk of homelessness stabilise their housing situation, particularly those people who are leaving institutions (like prisons). Homelessness services think that this type of intervention works best when it is ‘housing-led’. This is where people are given housing quickly without conditions. There have been no studies which have looked at how good housing-led CTIs are at stopping homelessness and improving the health of UK people who have left prison and if they are good value for money._x000D_
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Aims_x000D_
To carry out a pilot 'Randomised Controlled Trial (RCT)’ (where people are randomly allocated to receive either CTI or usual care) in prisons in England and Wales to find out if a full-scale RCT looking at ‘effectiveness’ (if it works) and ‘cost-effectiveness’ (if it is value for money) of a housing-led CTI should be done and to improve the study design._x000D_
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Method_x000D_
In the long term we plan to test if a housing-led CTI betters peoples health, quality of life and housing, but first we need to find out if the intervention and study design (research methods) are possible and acceptable. Our pilot RCT will include a ‘process and economic evaluation’ (a method to evaluate if/how the CTI has been implemented as intended and if it provides value for money) with people leaving prison recruited from 4 prisons. Half the participants will be randomly allocated to get the housing-led CTI and the other half will continue with the usual support provided by prisons, probation services and local authorities. We will follow up with all participants 3, 6, 9 and 12 months later. This study will tell us whether the CTI and study design is acceptable and if we should go ahead with a full trial looking at ‘effectiveness’ and ‘cost-effectiveness’ of the intervention. _x000D_
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PPI_x000D_
We will organise an Advisory Panel involving people who have experience of homelessness (from the Crisis Member Involvement Team) and professionals (government and the third sector) working across the UK in health, homelessness, and criminal justice sectors. Key organisations have already agreed to be part of this group (MCHLG). _x000D_
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Dissemination_x000D_
We will distribute our findings through academic journals and conferences; work with our advisory panel to develop blogs, infographics and press-releases; share findings directly with policy communities; use the social media outlets of the Centre for Trials Research, Social and Public Science Research Unit (SPHSU) and the Centre for Development, Evaluation, Complexity and Implementation in Public Health Improvement (DECIPHer).

Lay Abstract: Background: For people leaving prison, re-integrating into the community can be a difficult process. Substance use, poor mental health, personal and situational factors such as low levels of literacy and absence of a stable support network, reinforced by a lack of affordable housing and employment opportunities, make them particularly at risk of homelessness. The absence of stable accommodation has a devastating impact on health - people experiencing homelessness are more exposed than the general population to infectious and noncommunicable diseases, mental health problems (including alcohol and substance use), have higher rates of emergency hospital admissions and report lower levels of wellbeing and health-related quality of life._x000D_
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Aim: To conduct a pilot randomised controlled trial (RCT) in four male prisons to determine whether a future full-scale RCT assessing effectiveness and cost-effectiveness of a housing-led Critical Time Intervention (CTI) is warranted._x000D_
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Objectives: 1) To set-up the project. 2) Deliver trial delivery training and recruit participants. 3) Conduct a pilot RCT in four prisons (collect baseline data; randomise participants; follow-up data collection). 4) Conduct trial analysis (process evaluation; statistical analysis of outcomes; scoping and testing data linkages; economic evaluation). 5) Write-up and disseminate findings._x000D_
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Methods and timelines:_x000D_
Project set-up (Months 1-4): Finalise study protocol, trial steering committee and expert advisory group membership. Obtain ethics and governance approvals. Refine logic model and develop intervention and participant information materials._x000D_
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Training and recruitment (Months 5-9): Crisis, a national charity for people experiencing homelessness, will train their caseworkers to deliver CTI. Potential participants will be referred to Crisis from probation services and decisions on eligibility will be made at weekly allocation meetings._x000D_
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Trial delivery (Months 6-21): Following baseline data collection, individuals will be randomly allocated to CTI or treatment as usual. Follow-up data collection will take place after the individuals have been released from prison at 3, 6, 9 and 12 months._x000D_
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Trial analysis (Months 6-22): Qualitative data analysis will inform a process evaluation that explores key components (including intervention reach, recruitment and retention, acceptability and compliance). Statistical analysis will determine whether level of recruitment and retention meet the prespecified progression criteria. A scoping exercise will explore feasibility of linkage of trial data to administrative data sources and test linkages will be undertaken. Pilot economic evaluation analyses combined with a review of existing evidence will lead to the development of an economic conceptual model for the full-scale trial stage._x000D_
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Write-up and dissemination (Months 22-24): Report writing (dissemination plan below)._x000D_
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Anticipated impact and dissemination: We will report via the NIHR PHR monograph and two open access papers to high impact journals. We will disseminate findings to stakeholders in policy, public health, academia, and the public through seminars, conferences and public events. The key impact from our study will be knowledge on whether conducting a full-scale RCT of housing-led CTI is warranted. Looking longer term, if a future full-scale RCT finds housing-led CTI is effective and cost-effective we would aim for roll-out to prisons across the UK.

Research Activity Codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health Categories: GENERIC HEALTH RELEVANCE