SmokingPROSPERNCT04271371
Preventing Relapse to Smoking Among Prisoners After Release
An observational study of Smoking and Smoking Reduction, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Prisoners experience huge health inequalities, and their exceptionally high smoking prevalence (five times the national average) contributes significantly to their high mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Reduction, Electronic Cigarette Use
- What is being tested?
- Not yet developed
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male prisoner population
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham, School of Medicine
Nottingham, Please Select, NG5 1PB
About this study
Official title: Preventing Relapse to Smoking Among Prisoners After Release: Developing and Piloting a Complex Health Intervention
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.
Read the 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:
- 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.
- Drawing on current literature and findings from Phase 1, develop and design an prototype intervention to prevent smoking relapse after release.
- 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
- Being tested
- Not yet developed
- Keywords
- Smoking, Smoking Reduction, Electronic Cigarette Use, Prison
- Medical subject headings
- Smoking, Smoking Reduction, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not yet developedOther
A prototype intervention will be developed over Phase 1 \& 2 and piloted in Phase 3 of this study.
| Study group | Role | What they receive |
|---|---|---|
| Prototype intervention | To be developed through Phase 1 and 2 Receives: Other: Not yet developed |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.
Smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported.
Measured: 3 years
Secondary outcomes (18)
To document prisoners smoking history to date and levels of nicotine addiction.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
To document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
The impact of smoke-free prison policy on prisoners smoking behaviours.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
To establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release (and does their intended behaviour pre-release predict post-release behaviour).
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
To establish the extent to which prisoners relapse to smoking after transfer to an open prison where smoking is permitted in designated areas.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
To obtain views on triggers to smoking after release (and transfer to an open prison) and how relapse might be prevented.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
For those prisoners who return to smoking after release, at what point do they resume smoking (in days).
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
After release do prisoners use cessation pharmacotherapy, electronic cigarettes or NHS SSS support, or any other means of preventing relapse.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
Record and examine other potential predictors (as outlined in the international literature) of relapse to smoking after release from smoke-free prisons, e.g other negative health behaviours.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
For those prisoners who do return to smoking after release, do they smoke less, the same or more as they previously smoked before entering prison/and or before the prison service went smoke-free.
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
Review of methods of recruitment in prison and community follow-up (to feed into future pilot intervention study).
Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Measured: 1 year
To develop, design, and refine an intervention to prevent smoking relapse after release with input from fellow academics, stakeholders and PPI groups.
Phase 2 (Intervention development)
Measured: 1 year
To develop logic models to map the problem and the prototype intervention.
Phase 2 (Intervention development)
Measured: 1 year
To assess any barriers and facilitators to the developed intervention.
Phase 3 (Intervention pilot \& Intervention process evaluation)
Measured: 1 year
To explore any unintended consequences as a result of the intervention.
Phase 3 (Intervention pilot \& Intervention process evaluation)
Measured: 1 year
To identify aspects of the intervention and delivery that could be improved.
Phase 3 (Intervention pilot \& Intervention process evaluation)
Measured: 1 year
Explore smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported and CO validated.
Phase 3 (Intervention pilot \& Intervention process evaluation)
Measured: 1 year
Explore impact of the intervention on self-reported health, housing, reconviction rates, use of illicit substances in prisoner's post- release.
Phase 3 (Intervention pilot \& Intervention process evaluation)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start8 Aug 2019
- Primary completion1 May 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Her Majesty's Prison and Probation Service (HMPPS), Public Health England, Cancer Research UK, Plymouth University Peninsula Schools of Medicine & Dentistry (PUPSMD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271371
- Sponsor's protocol ID
- 254028
- Acronym
- PROSPER
- Status last verified
- Feb 2024
- First submitted
- 6 Sep 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Relapse to Smoking Among Prisoners After Release: Developing and Piloting a Complex Health Intervention
- ClinicalTrials.gov ID
- NCT04271371
- Acronym / sponsor ID
- PROSPER / 254028
- Conditions
- Smoking, Smoking Reduction, Electronic Cigarette Use
- Keywords
- Smoking, Smoking Reduction, Electronic Cigarette Use, Prison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Her Majesty's Prison and Probation Service (HMPPS), Public Health England, Cancer Research UK, Plymouth University Peninsula Schools of Medicine & Dentistry (PUPSMD)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Drawing on current literature and findings from Phase 1, develop and design an prototype intervention to prevent smoking relapse after release.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prototype intervention | – | Other: Not yet developedTo be developed through Phase 1 and 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male prisoner population
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not yet developedA prototype intervention will be developed over Phase 1 \& 2 and piloted in Phase 3 of this study. | Other | Prototype intervention |
Primary outcome
To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.
Time frame: 3 years
Smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported.
18 secondary outcomes
To document prisoners smoking history to date and levels of nicotine addiction.
Time frame: 1 year
To document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release.
Time frame: 1 year
The impact of smoke-free prison policy on prisoners smoking behaviours.
Time frame: 1 year
To establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release (and does their intended behaviour pre-release predict post-release behaviour).
Time frame: 1 year
To establish the extent to which prisoners relapse to smoking after transfer to an open prison where smoking is permitted in designated areas.
Time frame: 1 year
To obtain views on triggers to smoking after release (and transfer to an open prison) and how relapse might be prevented.
Time frame: 1 year
For those prisoners who return to smoking after release, at what point do they resume smoking (in days).
Time frame: 1 year
After release do prisoners use cessation pharmacotherapy, electronic cigarettes or NHS SSS support, or any other means of preventing relapse.
Time frame: 1 year
Record and examine other potential predictors (as outlined in the international literature) of relapse to smoking after release from smoke-free prisons, e.g other negative health behaviours.
Time frame: 1 year
For those prisoners who do return to smoking after release, do they smoke less, the same or more as they previously smoked before entering prison/and or before the prison service went smoke-free.
Time frame: 1 year
Review of methods of recruitment in prison and community follow-up (to feed into future pilot intervention study).
Time frame: 1 year
To develop, design, and refine an intervention to prevent smoking relapse after release with input from fellow academics, stakeholders and PPI groups.
Time frame: 1 year
To develop logic models to map the problem and the prototype intervention.
Time frame: 1 year
To assess any barriers and facilitators to the developed intervention.
Time frame: 1 year
To explore any unintended consequences as a result of the intervention.
Time frame: 1 year
To identify aspects of the intervention and delivery that could be improved.
Time frame: 1 year
Explore smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported and CO validated.
Time frame: 1 year
Explore impact of the intervention on self-reported health, housing, reconviction rates, use of illicit substances in prisoner's post- release.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking Reduction, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.