Preventing Relapse to Smoking Among Prisoners After Release

NCT ID: NCT04271371

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-08
• Study Completion Date: 2023-12-30

Brief Summary

Prisoners experience huge health inequalities, and their exceptionally high smoking prevalence (five times the national average) contributes significantly to their high mortality. Since the introduction of smoke-free polices across Her Majesty's Prison and Probation Service (HMPPS) in England and Wales, prisoners are now obliged to abstain from smoking while held in prison. This represents a unique opportunity to promote lifelong cessation in this highly disadvantaged and marginalised group. However, evidence suggests most prisoners intend to resume smoking as soon as possible after release. A systematic review of prison smoke-free polices worldwide concluded that there was a need for new research to identify effective strategies to reduce relapse in these individuals.

Detailed Description

The primary objective of this study will be to develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release. The study will work in accordance with the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The Preventing Relapse tO Smoking among PrisonErs after Release (PROSPER) study consists of three key Phases:

1. Document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release; establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release; and obtain views on how relapse might be prevented.

2. Drawing on current literature and findings from Phase 1, develop and design an prototype intervention to prevent smoking relapse after release.

3. To pilot the designed prototype intervention and conduct a process evaluation to inform the development of further work in this area.

The research will be carried out in three prisons in the East Midlands. The main duties will include recruitment of participants (HMPPS staff members and prisoners), data collection, data analysis, assist with intervention development and refining related intervention materials/resources, co-facilitate Patient and Public Involvement (PPI) groups, contribute to the ethical application for the pilot intervention, and preparation of manuscripts for peer-review publication.

Conditions

Smoking; Smoking Reduction; Electronic Cigarette Use

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prototype intervention

To be developed through Phase 1 and 2

Not yet developed

Intervention Type: OTHER

A prototype intervention will be developed over Phase 1 \& 2 and piloted in Phase 3 of this study.

Interventions

Not yet developed

A prototype intervention will be developed over Phase 1 \& 2 and piloted in Phase 3 of this study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All participants are aged 18 or over (no upper age limit)
• Are currently residing in one of the three study sites (HMPs Nottingham, Ranby and Sudbury)
• Male (women will not be held at any of the study sites)
• Have a provisional release date within the next 2 months.
• Are capable of understanding and consenting to the study.
• Remand and sentenced prisoners.
• Who report that they are a current smoker and/or a current smoker prior to entering prison (smoked up to 7 days before entering prison), and/or were in prison (and still on the same sentence) and a current smoker prior to the smoke-free prison policy.

3. Reception prisoner cross-sectional

• All participants are aged 18 or over (no upper age limit)
• Are currently residing in the open prison study site (HMP Sudbury)
• Male (women will not be held at any of the study sites)
• Have been in the open prison more than two weeks but for less than 3 months.
• Have been transferred from a closed prison.
• Are capable of understanding and consenting to the study.
• Sentenced prisoners.
• Who report that they were a current smoker prior to entering prison (smoked up to 7 days before entering prison), and/or were in prison (and still on the same sentence) and a current smoker prior to the smoke-free prison policy.

Exclusion Criteria

• Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.
• Non-smokers.
• Being deported post release.
• Been in prison for less than four weeks.

3. Reception prisoner cross-sectional

• Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.
• Been in prison for less than 2 weeks.
• Non-smokers.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Her Majesty's Prison and Probation Service (HMPPS)

UNKNOWN

Sponsor Role: collaborator

Public Health England

OTHER_GOV

Sponsor Role: collaborator

Cancer Research UK

OTHER

Sponsor Role: collaborator

Plymouth University Peninsula Schools of Medicine & Dentistry (PUPSMD)

UNKNOWN

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Nottingham, School of Medicine

Nottingham, Please Select, United Kingdom

Countries

United Kingdom

Other Identifiers

254028

Identifier Type: -

Identifier Source: org_study_id