Multicentre RCT and economic evaluation of a psychological intervention together with a leaflet to reduce risk behaviour amongst men who have sex with men (MSM) prescribed post-exposure prophylaxis for HIV following sexual exposure (PEPSE): a protocol.

Abstract

Post-exposure prophylaxis (PEP) following sexual exposure to HIV has been recommended as a method of preventing HIV infection in the UK. Men who have sex with men (MSM) are the group most affected by HIV in the UK and their sexual risk taking behaviour is reported to be increasing. One-to-one behavioural interventions, such as motivational interviewing (MI) have been recommended to reduce HIV in high risk groups. The Information, Motivation and Behavioral skills (IMB) model has been shown to provide a good basis for understanding and predicting HIV-relevant health behaviour and health behaviour change, however the IMB has yet to be applied to PEP after risky sexual exposure. The primary aim of this trial is to examine the impact of MI augmented with information provision and behavioural skills building (informed by the IMB Model), over and above usual care, on risky sexual behaviour in MSM prescribed PEP after potential sexual exposure. A secondary aim of this research is to examine the impact of the intervention on adherence to PEP. This study will also provide estimates of the cost-effectiveness of the intervention.
A manualised parallel group randomised controlled trial with economic evaluation will be conducted. The primary outcome is the proportion of risky sexual practices. Secondary outcomes include: i) Levels of adherence to PEP treatment; ii) Number of subsequent courses of PEP; iii) Levels of motivation to avoid risky sexual behaviours; iv) Levels of HIV risk-reduction information/knowledge; v) Levels of risk reduction behavioural skills; vi) Diagnosis of anal gonorrhoea, Chlamydia and/or HIV. 250 participants will be asked to self-complete a questionnaire at four time points during the study (at 0,3,6,12 months). The intervention will consist of a two-session, fixed duration, telephone administered augmented MI intervention based on the IMB model. A newly developed treatment manual will guide the selection of persuasive communication strategies as appropriate for each participant and will be based on underlying change mechanisms specified by the IMB theoretical framework. Information provision and skills building will also be included in the intervention package through the use of information leaflets and tailored action plans. Fidelity of intervention delivery will be assessed.
The results from this NIHR funded study will identify whether it is appropriate and cost-effective to intervene using one-to-one telephone calls with MSM seeking PEP. If the intervention is effective, further work will be needed on training staff to deliver the intervention competently. TRIAL REGISTRATION NUMBERS: UKCRN ID:11436; ISRCTN00746242.

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STUDY PROTOCOLOpen Access
Multicentre RCT and economic evaluation of a
psychological intervention together with a leaflet
to reduce risk behaviour amongst men who have
sex with men (MSM) prescribed post-exposure
prophylaxis for HIV following sexual exposure
(PEPSE): A protocol
Carrie Llewellyn1*, Charles Abraham2, Alec Miners3, Helen Smith1, Alex Pollard1, Paul Benn4and Martin Fisher5
Abstract
Background: Post-exposure prophylaxis (PEP) following sexual exposure to HIV has been recommended as a
method of preventing HIV infection in the UK. Men who have sex with men (MSM) are the group most affected by
HIV in the UK and their sexual risk taking behaviour is reported to be increasing. One-to-one behavioural
interventions, such as motivational interviewing (MI) have been recommended to reduce HIV in high risk groups.
The Information, Motivation and Behavioral skills (IMB) model has been shown to provide a good basis for
understanding and predicting HIV-relevant health behaviour and health behaviour change, however the IMB has
yet to be applied to PEP after risky sexual exposure. The primary aim of this trial is to examine the impact of MI
augmented with information provision and behavioural skills building (informed by the IMB Model), over and
above usual care, on risky sexual behaviour in MSM prescribed PEP after potential sexual exposure. A secondary
aim of this research is to examine the impact of the intervention on adherence to PEP. This study will also provide
estimates of the cost-effectiveness of the intervention.
Methods: A manualised parallel group randomised controlled trial with economic evaluation will be conducted.
The primary outcome is the proportion of risky sexual practices. Secondary outcomes include: i) Levels of
adherence to PEP treatment; ii) Number of subsequent courses of PEP; iii) Levels of motivation to avoid risky sexual
behaviours; iv) Levels of HIV risk-reduction information/knowledge; v) Levels of risk reduction behavioural skills; vi)
Diagnosis of anal gonorrhoea, Chlamydia and/or HIV. 250 participants will be asked to self-complete a
questionnaire at four time points during the study (at 0,3,6,12 months). The intervention will consist of a two-
session, fixed duration, telephone administered augmented MI intervention based on the IMB model. A newly
developed treatment manual will guide the selection of persuasive communication strategies as appropriate for
each participant and will be based on underlying change mechanisms specified by the IMB theoretical framework.
Information provision and skills building will also be included in the intervention package through the use of
information leaflets and tailored action plans. Fidelity of intervention delivery will be assessed.
Discussion: The results from this NIHR funded study will identify whether it is appropriate and cost-effective to
intervene using one-to-one telephone calls with MSM seeking PEP. If the intervention is effective, further work will
be needed on training staff to deliver the intervention competently.
* Correspondence: c.d.llewellyn@bsms.ac.uk
1Brighton & Sussex Medical School, Brighton, UK
Full list of author information is available at the end of the article
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http://www.biomedcentral.com/1471-2334/12/70
© 2012 Llewellyn et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.

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Trial registration numbers: UKCRN ID:11436; ISRCTN00746242.
Keywords: Sexual behaviour, HIV, Motivational interviewing, Post-exposure-prophylaxis, Intervention
Background
The prevalence of HIV infections continue to rise in the
UK, particularly amongst MSM and the reduction of
new infections is a key component of the National Strat-
egy for Sexual Health and HIV [1]. Recent reports on
sexual health highlight the need to invest more in HIV
prevention strategies [2,3]. The Community HIV and
AIDS prevention (CHAPS) policy (led by the Terrence
Higgins Trust) identifies post-exposure prophylaxis fol-
lowing sexual exposure (PEPSE) to the human immuno-
deficiency virus (HIV) as one method of preventing HIV
infection in the UK [4]. Recommendations for treatment
are derived from the existing use of antiretrovirals to
prevent HIV infection after high risk occupational expo-
sure to the virus (’needle-stick injuries’) [5]. Recommen-
dations for prescribing PEP result from the clinician’s
assessment of risk of transmission. If the risk of HIV
transmission through particular sexual practices (such as
unprotected anal intercourse) is of a similar magnitude
as occupational exposures then PEP should be recom-
mended [6].
Evidence suggests that PEP may reduce the risk of
HIV infection if given within 72 hours and adhered to
rigorously for 28 days [5,7,8]. Sustained adherence is
required to prevent treatment failure, however, non-
adherence of a quarter to a third of those prescribed
PEP has been reported [9,10]. The treatment can be
challenging to patients due to side-effects such as diar-
rhoea, nausea, headaches and vomiting. The treatment
is also costly.
Men who have sex with men (MSM) are the group
most affected by the HIV epidemic in the UK [11] and
their sexual risk taking behaviour is reported to be
increasing [12,13]. As part of a comprehensive strategy
across HIV prevention and care, behavioural interven-
tions remain an important tool in the global fight
against HIV [14]. One-to-one behavioural interventions,
such as motivational interviewing (MI) have been
recommended [15,16] to reduce HIV in high risk
groups. NICE guidance places recommendations for
one-to-one interventions within the context of current
STI/HIV service provision [1,17] and states that these
interventions are integral to the modernisation of sexual
health services [16]. Seeking PEP after potential sexual
exposure may indicate an unmet prevention need and
provides an opportunity to target interventions thus
potentially lowering the likelihood of further risk beha-
viour [18,19].
We will implement a telephone-administered interven-
tion based on motivational interviewing (MI) augmented
with information and behavioural skills building
(informed by the Information-Motivation-Behavioral
Skills Model). MI is defined as a ‘directive, client-
centred counselling style for eliciting behaviour change
by helping clients to explore and resolve ambivalence’
[20]. It is may be especially effective for individuals who
are reluctant to change or who are ambivalent about
changing their behaviour and may be particularly appro-
priate for MSM who may require a more tailored pre-
ventive strategy. A systematic review and meta-analysis
of RCTs shows that MI outperforms traditional advice
giving in the treatment of a range of behavioural pro-
blems and diseases [21]. More recently, a pilot study has
shown the effectiveness of telephone administered MI to
reduce risky sexual behaviour in HIV infected rural
populations [22].
The study will examine whether a two-session, tele-
phone administered augmented motivational interview-
ing intervention based on the IMB model (Figure 1)
reduces risky sexual behaviour (compared with ‘treat-
ment as usual’), in MSM prescribed PEP treatment after
potential sexual exposure to HIV. Evidence suggests that
the Information-Motivation-Behavioral Skills (IMB)
approach could be used to explain sexual risk taking
behaviour [23]. Moreover, the IMB model has been
shown to provide a good basis for understanding and
predicting HIV-relevant health behaviour and health
behaviour change in almost two decades of research
[24]. This model further proposes that information rele-
vant to the personal practice of preventive behaviour,
motivation to practice prevention and behavioural skills
for practicing prevention effectively, are fundamental
determinants of HIV/STI preventive behaviour [25]. The
IMB model proposes an intervention development pro-
cess involving (1) elicitation of client resources and
needs and, (2) matching intervention content to existing
Information
Motivation
Behavioural
Skills
Sexual
Behaviour
Figure 1 The Information-Motivation-Behavioral Skills Model
(Fisher and Fisher, 1992).
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need and behaviour change objectives, (3) implementa-
tion of information, motivation and skill development
techniques interventions according to protocol and,
finally, (4) evaluation.
Interventions based on this approach has been found
to be effective in changing risky sexual behaviour
among HIV negative and infected individuals in more
than 25 studies [26] and in changing levels of adherence
behaviour amongst people with HIV/AIDS [27,28]. The
IMB has yet to be applied to a short term prophylactic
regimen of medication after risky sexual exposure but
its previous successful application to HIV risk reduction
suggests that it is an appropriate model on which to
base an intervention for those prescribed PEP. This
study will also provide estimates of the cost-effectiveness
of the intervention through the inclusion of an eco-
nomic evaluation.
Objectives and hypotheses
The primary aim is to examine the impact of motiva-
tional interviewing augmented with information and
behavioural skills building (informed by the Informa-
tion-Motivation-Behavioral Skills Model), over and
above usual care, on risky sexual behaviour in MSM
prescribed PEP after potential sexual exposure. A sec-
ondary aim of this research is to examine the impact of
the intervention on adherence to PEP.
Specifically we hypothesize that compared with treat-
ment as usual, those in the intervention arm will:
1) Report a reduction in the proportion of risky sexual
practices (less unprotected anal intercourse (UAI)
(receptive and insertive), increased use of condoms, a
reduction in partners);
2) Have greater levels of adherence to PEP treatment;
3) Have lower rates of subsequent requests for PEP;
4) Have lower incidences of HIV.
5) Have lower incidences of anal gonorrhoea and
Chlamydia;
6) Have greater motivation to avoid risky sexual
behaviours;
7) Have greater knowledge of risk reduction strategies;
8) Have greater risk reduction behavioural skills.
Methods
Study design
Parallel group randomised controlled trial (Figure 2).
Participants
Eligibility criteria
Participants will be MSM, aged ≥16 years, prescribed
PEP after sexual exposure, attending a Genito-urinary
Medicine (GUM) clinic that are willing and able to give
written, informed consent.
Exclusion criteria
The following groups of patients will be excluded: peo-
ple who have received previous psychological support
from a clinical psychologist in relation to their sexual
risk taking; people with learning difficulties; or those
unable to read study materials; or with no means of
communication acceptable to the patient; or who are
seeking PEP after sexual assault.
Recruitment procedure
The data collection plan is tailored to the standard
patient care protocols stipulated in the BASHH guide-
lines for PEP [4], and the clinical processes in use at the
recruitment sites. PEP is available from GUM or Acci-
dent & Emergency (A&E) Departments. Patients are
routinely prescribed a 5-day course of PEP medication
at general GUM clinics, or at A&E departments outside
of GUM hours. Whichever mode of access, all patients
attend a dedicated PEP clinic at GUM within 5 days of
initial prescription. Recruiting at the GUM clinic will
ensure all patients who are prescribed the full course of
PEP (28 days) are included in the trial from either
access route. Eligible participants will be identified by a
Figure 2 CONSORT flowchart of study participants.
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research nurse/health advisor at the GUM clinic and
given study information and consent forms. Participants
have a two-week time period in which to consent and
return baseline measures. This two week period allows
the recruitment of patients at an early stage in their pre-
scription, but at a time when their immediate anxiety
should be reduced and they are able to give considered,
informed consent.
Baseline and follow-up assessments
Participants enrolled into the study will be asked to self-
complete a questionnaire at four time points during the
study (at 0,3,6,12 months). The baseline questionnaire
will be administered at the recruitment stage. Upon
receiving the consent forms and baseline assessments,
participants will be randomly allocated to either inter-
vention or control conditions (see randomisation sec-
tion). The second questionnaire will be either posted to
patients, accessed via an email link or the internet (as
per consent) prior to their 3-month follow-up appoint-
ment with the clinic. Any patients who have not
returned completed questionnaires before their ‘3-
month’ follow-up will be sent repeat copies1(as per
consent), and subsequently called on the telephone (if
consented), and finally, may be approached by study
staff at their clinic appointment. The third and fourth
questionnaires will be posted to patients or accessed via
an email link or the internet 6 and 12 months after the
end of PEP. Repeat copies, and subsequent telephone
calls/text messages, will be used as reminders.
The recruitment period is for 12 months to allow suf-
ficient numbers of participants to be recruited. A sample
size of 250 (allowing for a 75% recruitment rate and
50% retention rate) is achievable within the time-frame
from four sites and we anticipate that numbers will be
higher given the increasing trends for PEP requests.
Randomization and blinding
Participants will be randomised after consent and collec-
tion of baseline measures. The recruiting staff will not
have access to the results of randomisation prior to
recruiting the participant. Randomisation will occur
within each clinic. The allocation sequence will be gen-
erated and released to the interventionist on a case-by-
case basis by an independent company who specialise in
supplying random generated sequences for research.
The randomisation sequence will be recorded. This is a
single-blind trial, given the nature of the behavioural
intervention, blinding of participants is not feasible and
the interventionist will know that all those contacted are
in the intervention arm. The statistician will be blind to
individual results during the trial and the allocation-to-
trial-arm coding will be revealed when the dataset is
sealed. The interventionist and supervisors will be blind
to the baseline and follow-up measures which will not
be involved in the delivery of the intervention. Anon-
ymised responses will be entered onto the database by a
person unconnected to the project.
Trial treatment arms
Control group: Treatment as usual
Both of the groups will receive ‘treatment as usual’:
Patients are initially seen by a HA/SpN for an initial
consultation, 5 day prescription of PEP and blood tests
(for HIV, Hepatitis B and liver function). Patients
receive their first follow-up appointment 5 days later to
receive further PEP (if HIV-ve). After the 28 day treat-
ment regimen patients receive either a face-to-face or
telephone appointment with the HA/SpN to discuss
their sexual health, adherence to PEP and the blood test
results. At 4 months after exposure (3 months after the
end of PEP) patients are recalled by the HA for HIV
testing. In order to assess the impact of the intervention
on outcome measures and IMB constructs, those allo-
cated to the control group will be asked to complete all
measures at 0,3,6, and 12 months.
Intervention group
Procedure
The intervention group will receive ‘treatment as usual’
plus the addition of an intervention which will be deliv-
ered as two telephone sessions employing motivational
interviewing (MI) augmented with information and skills
building based on the IMB model of behaviour change.
The first telephone call will be made within one week of
the participant being consented into the trial and after
baseline assessments are received. The second call will
occur 7 days (+/-2 days) later. The intervention will be
completed by the end of the 28 day course of PEP. A
telephone format is proposed to allow the same person
to conduct all interventional sessions to control for pro-
vider differences and to facilitate recruitment from a
wide geographical area in an economical manner. If
shown to be effective, this intervention would be sus-
tainable as an improvement to the routine care model.
Duration and content of intervention
Telephone delivered MI
Each telephone session will be a maximum of 30 min-
utes long. The second session will contain similar con-
tent to the first but will reiterate and build on the risk
reduction motivation from session 1. In the case of
drop-out between the 2 intervention sessions, the dose-
response will be assessed.
The interventionist will initially assess individual risk
behaviours and any informational, motivational or skill
deficits which have contributed to maintenance of parti-
cipants’ risky sexual behaviours and discuss particular
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areas related to risky sex e.g. the use of alcohol or drugs
during sex. The interventionist will elicit self-motiva-
tional statements from the participant with the use of
open-ended questions and will utilise MI strategies to
increase motivation to change, including:
1) Providing the participant with feedback about his
risky sexual behaviours
2) Increasing the participant’s sense of responsibility
to reduce risky sexual behaviours
3) Providing brief and direct advice to create a desire
for change
4) Providing a menu of options from which the parti-
cipant can choose to reduce risk
5) Demonstrating empathy by listening carefully, and
accurately understanding his problems
6) Enhancing self-efficacy to reduce risky sexual beha-
viours [29]
If an individual discontinues with PEP before the end
of the treatment, they will still be eligible to continue in
the study. Data on adherence to PEP will be captured by
the measures of adherence and a review of the medical
notes.
The role of the manual
The manual will guide the selection of persuasive com-
munication strategies appropriate for each participant
and will be based on underlying change mechanisms
specified by the IMB theoretical framework. The manual
describes how to elicit information and includes scripts
describing likely sexual-risk scenarios. Specific behaviour
change techniques are identified [30,31] and possible
responses exemplified.
Information provision and skills building
Information about HIV risk behaviour, prevalence and
strategies to minimise risk will be provided to those
allocated into the intervention arm (’Ready for Action’
Second Edition, and ‘Get it on’ condom guide both pro-
duced by the Terrence Higgins Trust). This will be
either sent by post, email or accessed via the internet
(as preferred) after baseline measures have been
returned but before the intervention. The interventionist
will prompt the participant to read the information if
they have not already done so.
The skills building component of the intervention will
be given during the telephone session in the form of
interventionist-provided suggestions of practical strate-
gies needed to master these skills. A well-specified
action plan will be developed and agreed on (between
interventionist and participant) during the session and
the participant will be asked to write this down and
enact it. The interventionist will also write down the
agreed action plan and send this to the participant after
the session (either by post,or email as indicated by
participant). Questions about adherence to practicing
the action plan are included in the follow-up
questionnaires.
Treatment fidelity
Assessing the fidelity of the treatment is an important
component of successful research dissemination. Trans-
lating effective behavioural change interventions from
this research setting to clinical practice can be facilitated
better when treatment fidelity strategies are used as
guidelines for implementing new interventions in clini-
cal contexts. In order to monitor the reliability and
validity of the intervention, assessment of both the inter-
ventionist and the participant will conducted as per
National Institutes of Health (NIH) Behaviour Change
Consortium ‘best practice’ recommendations. Ensuring
same treatment dose within conditions will be ensured
by a fixed number of sessions and by delivery within the
intervention period. Ensuring interventionist skill acqui-
sition and minimising ‘drift’ in interventionist skills will
be minimised by the development and use of a treat-
ment manual; by monitoring and providing feedback to
the interventionist; and by providing adequate training.
The gold standard method to ensure standard delivery
of the intervention is to evaluate or code the sessions
(through audiotape) according to predefined criteria. A
validated instrument, the Motivational Interviewing Skill
Code (MISC) [29], will be used to provide structured
feedback, to monitor and document adherence to MI
principles during weekly supervision. The interventionist
will also be required to complete a process evaluation
checklist (adapted from the NHS Health Trainer Hand-
book [32]) after each intervention session to remind
him to include the appropriate skills and content for
each intervention and minimise bias. The advisory
board will be used to monitor whether the treatment
protocol has been adhered to during the recruitment
and intervention period. Reduction of differences within
treatments will be ensured by the use of one trained
interventionist.
Measures
Primary outcome
The proportion of risky sexual practices.
Risk Behaviour outcome measure
A Risk Behaviour outcome measure has been developed
to include items of potential HIV transmission-risk sex-
ual behaviour: number of episodes of unprotected anal
intercourse (UAI) (receptive and insertive) over a three
month time period with individuals of unknown or HIV
positive status, consistency of condom use, number of
partners using no protection.
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(Unprotected receptive oral sex with an HIV + ve per-
son is associated with minimal HIV transmission risk
and thus is not included).
Secondary outcomes (and method of assessment)
i) Levels of adherence to PEP treatment (Morisky Medi-
cation Adherence Scale (MMAS) [33] adapted for use in
PEP).
ii) Number of subsequent courses of PEP (self-report
and medical record review).
iii) Diagnosis of anal gonorrhoea and Chlamydia.2
iv) Diagnosis of HIV.
v) Levels of motivation to avoid risky sexual beha-
viours (’Measures of Motivation to Perform AIDS Pre-
ventive Behavior’ questionnaire [34] adapted for use
with MSM. This questionnaire provides assessment of
attitudes, subjective norms and behavioural intentions in
relation to HIV risk-reduction).
vi) Levels of HIV risk-reduction information/knowl-
edge (’Health and Relationships Survey’ [34] adapted for
use with MSM. Items are summed to form an HIV pre-
vention information scale score).
vii) Levels of risk reduction behavioural skills (’Beha-
vioral Skills Measure’ [34]. This consists of two sub-
scales which assess the perceived difficulty of reducing
HIV risk behaviour and the perceived effectiveness of
methods to reduce risk).
With the exception of adherence, all outcome mea-
sures will use a retrospective recall period of ‘the past 3
months’. Other factors assessed by self-report question-
naire at each time point will be alcohol and substance
use. Socio-demographic (age, ethnicity, education,
employment, relationship status) will be assessed at
baseline. Experience of treatment side-effects will be
assessed using a previously used measure at 3 month
together with the measure of adherence.
Frequency and duration of follow-up
The primary and secondary outcomes ii, v, vi, and vii
will be collected at 3, 6 and 12 months after the end of
treatment (and the end of the intervention). Secondary
outcome i. will be collected at 3 months only. Outcomes
iii. and iv. will be collected at 12 months only.
The follow-up period is for 12 months to determine
intervention sustainability. Participants will be contacted
by telephone prior to each follow-up assessment to
remind them of their participation in the study and to
ask their preference for follow-up (postal, email/internet
or face-to-face).
Analyses plan and power calculation
For the analysis of main effects for the primary outcome
a mixed-design ANCOVA will be used with one
between-groups factor (treatment vs. control) and one
within-groups factor (baseline, 3-,6- and 12-month mea-
sures). For this analysis the estimated effect size is f =
0.1 (based on a moderate estimate of effect size from a
meta-analysis [24] of one to one interventions to reduce
UAI in MSM). 90% power at 0.05 level of significance
requires a sample of 250 (125 in each arm). Secondary
outcomes will be analysed for the same effect size but
with significance adjusted to 0.01 and power to 80%.
Piloting
All study materials (measures, training manual, interven-
tion, method for data sharing) will be piloted on a sam-
ple of MSM and refined in response to their feedback,
together with input from the Advisory Board and Steer-
ing Group.
Economic evaluation
The economic evaluation will compare NHS costs of the
intervention with usual care. Health outcomes will be
expressed as quality-adjusted life-years (QALYs). Deci-
sion modelling techniques will be used to extrapolate
the RCT results to predict longer term costs and health
outcomes. A single economic model with an appropriate
time horizon is proposed based on Bernoulli techniques.
This approach has been used in a number of previously
published studies [35]. This is a conservative approach
because it only partially accounts for chains of infections
which may be prevented, rather than prevention of sin-
gle infections.
The purpose of the Bernoulli model is to translate
changes in sexual behaviour as observed in the trial into
the probability of HIV transmission in order to estimate
the number of averted transmissions. To inform this
model, baseline data will be collected to allow a more
complex infectious diseases model to be built if the
intervention is proven. The data are likely to be useful
for a range of other HIV modelling studies. Intervention
costs will be collected contemporaneously. The longer
term costs and health effects of HIV infection will be
estimated using published evidence since infection-asso-
ciated sequelae will not occur during the trial period.
Future costs and QALYs will be discounted at 3.5% per
annum. Results will be reported as incremental cost per
QALYs and cost-effectiveness acceptability curves.
Vulnerable patients and disclosures
If during the intervention the patient discloses current
harmful thoughts or behaviour towards themselves or
another, they will be referred to their treating consul-
tant, GP or psychiatric support provided by the GUM
clinic. The breaking of confidentiality under these cir-
cumstances is detailed on the consent form.
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Anonymity and confidentiality of data
Participants anonymity will be protected by the alloca-
tion of a code (not a clinic or NHS number) for use on
the database.
Confidentiality and data sharing between participant sites
All patient-related information to be shared through
encrypted NHS email system.
Ethical approval
The study protocol was approved by the National
Research Ethics Service (NRES) Committee South East
Coast - Surrey (ref: 11/LO/0718) in 2011.
Discussion
This paper describes the protocol of a randomised con-
trolled trial to evaluate the impact of motivational inter-
viewing augmented with information and behavioural
skills building (informed by the Information-Motivation-
Behavioural Skills Model), over and above usual care, on
risky sexual behaviour in MSM prescribed PEP after
potential sexual exposure. A secondary aim of this
research is to examine the impact of the intervention on
adherence to PEP. This study will also provide estimates
of the cost-effectiveness of the intervention through the
inclusion of an economic evaluation.
One of the strengths of this study is that the interven-
tion is targeting individuals who may be deemed as high
risk: those who have presented for PEP treatment after a
potential sexual exposure. Men who have sex with men
(MSM) are the group most affected by the HIV epi-
demic in the UK [11] and their sexual risk taking beha-
viour is reported to be increasing [12,13]. As part of a
comprehensive strategy across HIV prevention and care,
behavioural interventions remain an important tool in
the global fight against HIV [14]. One-to-one beha-
vioural interventions, such as motivational interviewing
(MI) have been recommended [15,16] to reduce HIV in
high risk groups. Although the intervention is tailored
to the individual, our proposed intervention is manua-
lised so that the content delivered will be similar and
based on the principles of MI with the underlying
change mechanisms specified by the IMB Model. As
part of this study a manual has been developed. Specific
behaviour change techniques used will then be able to
be identified and quantified. Translating effective beha-
vioural change interventions from the research setting
to clinical practice can be facilitated better when treat-
ment fidelity strategies are used as guidelines for imple-
menting new interventions in clinical contexts. We will
be monitoring the reliability and validity of the interven-
tion which is an additional strength of the study.
A recent review [14] highlighted that the recruitment
of MSM participants was the most challenging aspect of
similar behavioural intervention studies. To overcome
these barriers we are employing strategies to ensure that
recruitment and retention are maximised, including: the
refinement of assessment materials with the MSM com-
munity; the use of a telephone-based intervention to
overcome geographic boundaries, time constraints and
fear of public exposure as an MSM; the recruitment of
individuals seeking PEP rather than the recruitment of
high risk individuals from the community.
This study will identify whether it is appropriate and
cost-effective to intervene using a tailored intervention
of one-to-one telephone calls with MSM prescribed the
prophylactic treatment regimen after potential sexual
exposure to HIV. If the intervention is effective, further
work will be needed on training staff to deliver the
intervention competently.
Endnotes
1Maximum of 2 repeat copies and 1 text/call/email if
consented by patient.
2Incidence data on rectal gonorrhoea and Chlamydia
will be collected as this is directly related to the risky
sexual behaviour that we are assessing in this trial i.e.
directly related to condom use.
Acknowledgements and funding
This paper presents independent research commissioned by the National
Institute for Health Research (NIHR) under its Research for Patient Benefit
(RfPB) Programme (Grant Reference Number PB-PG-0110-21005). The views
expressed are those of the authors and not necessarily those of the NHS,
the NIHR or the Department of Health. We acknowledge the support of the
National Institute for Health Research, through the Comprehensive Clinical
Research Network. Thanks to Dr Matthew Hankins and Stephanie Goubet for
statistical advice. Thanks to our Advisory Group who have been involved
with developing materials during the developmental phase of this study.
Thanks to the clinicians and staff at the recruiting centres who have
supported the study through the governance phase.
Author details
1Brighton & Sussex Medical School, Brighton, UK.2Peninsula College of
Medicine & Dentistry, Exeter, UK.3London School of Hygiene & Tropical
Medicine, London, UK.4Camden Provider Services at Central and North West
London NHS Foundation Trust, London, UK.5Brighton and Sussex University
Hospitals NHS Trust, Brighton, UK.
Authors’ contributions
CL, MF, CA, HS, AP, PB, AM contributed to the design of the study and co-
authored this article. All authors have read and approved the final
manuscript.
Competing interests
The authors declare that they have no competing interests.
Received: 13 January 2012 Accepted: 22 March 2012
Published: 22 March 2012
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Pre-publication history
The pre-publication history for this paper can be accessed here:
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doi:10.1186/1471-2334-12-70
Cite this article as: Llewellyn et al.: Multicentre RCT and economic
evaluation of a psychological intervention together with a leaflet to
reduce risk behaviour amongst men who have sex with men (MSM)
prescribed post-exposure prophylaxis for HIV following sexual exposure
(PEPSE): A protocol. BMC Infectious Diseases 2012 12:70.
Llewellyn et al. BMC Infectious Diseases 2012, 12:70
http://www.biomedcentral.com/1471-2334/12/70
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