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21/542 Medication to manage sexual preoccupation in sex offenders

Contents

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

What is the clinical and cost-effectiveness of medication(s) used to manage sexual preoccupation in adult males with convictions for a sexual offence?

  1. Intervention: Medication(s) currently used in the Medical Management of Sexual Arousal programme (MMSA) e.g. Selective serotonin reuptake inhibitors (SSRIs).
  2. Target group: Adult male prisoners convicted of a sexual offence(s) and who experience sexual preoccupation as measured by a validated tool.  Applicants to define and justify exact criteria.
  3. Setting: Prisons.
  4. Control: Placebo.
  5. Study design: Randomised controlled trial. Applicants to define the most appropriate design to answer the research question, taking into account the differences in patient group criteria. There should be an internal pilot phase to test key trial processes such as recruitment and adherence and clear stop/go criteria to inform progression from pilot to full trial.  Applicants should give consideration to the use of efficient trial designs and to treatment and follow up for participants released from prison during the trial.
  6. Important outcomes: Distressing sexual preoccupation; hypersexual behaviour (e.g. as measured by the Sexual Compulsivity Scale).
    Other outcomes: Mental and physical wellbeing; side effects; adverse effects; user acceptability; use of prison activities; engagement with other treatment programmes; adherence; use of other medication(s); cost-effectiveness.
    Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise.
  7. Minimum duration of follow-up: 1 year.  Applicants to justify when the primary outcome will be measured within this period.
  8. Longer-term follow up: Researchers should obtain consent to allow for future follow up through efficient means (such as routine data) as part of a separately funded study e.g. to measure rates of reoffending. 

Rationale

Approximately 16% of the sentenced male prison population in England and Wales has committed a sexual offence. Sexual offences include non-consensual crimes such as sexual assault or rape. The estimated economic and social costs of sexual offences are high taking in to account the physical and emotional harm experienced by victims as well as the costs to the NHS, police and Criminal Justice Service.

Treatment for adult males with convictions for a sexual offence has predominantly been psychological but outcomes from these interventions have not shown consistent effectiveness. The reasons for this are unclear but it has been suggested that psychological treatment programmes may not address the high levels of sexual preoccupation experienced by some offenders. Sexual preoccupation has been defined as an abnormal intense interest in sex that dominates psychological functioning and can be measured by various tools, including the Sexual Compulsivity Scale. There is a strong association between sexual preoccupation and reoffending.

This identified gap in treatment led to a growing interest in the role of pharmacology. In 2007, HM Prison and Probation Service piloted the use of medications with the aim of reducing problematic sexual preoccupation in adult males with convictions for a sexual offence. Initial evaluations of the pilot indicated that medications such as selective serotonin reuptake inhibitors (SSRIs) and testosterone-suppressing Anti-androgens led to a reduction in sexual preoccupation. The Medical Management of Sexual Arousal (MMSA) programme is now established in eight prisons. As part of the programme, SSRIs are the most commonly prescribed medication.  Testosterone-suppressing medication is used when SSRIs are not helpful or for those with very high levels of sexual activity or sex drive which a person finds difficult to control. Whether an offender has had psychological therapy or not does not affect their eligibility to be prescribed medication as part of the MMSA programme.

However, despite the widespread use of these medications, there is a lack of robust evidence to inform clinician and patient decision-making. High quality research data could contribute to improving the treatment of this group, which may have significant potential benefits for wider society. Therefore, the HTA programme is now interested in commissioning research in this area. Applicants should describe how key stakeholders, e.g. The Offender Personality Disorder (OPD) pathway programme, will be engaged with throughout the research process.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 1 December 2021. Applications will be considered by the HTA Funding Committee at its meeting in January 2022.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition. For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us by email htacommissioning@nihr.ac.uk.