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    Clinical Trial Results:
    The role of Home packs of HIV Post-Exposure Prophylaxis for sexual exposure (PEPSE) to improve the speed and appropriate uptake of PEPSE in high risk individuals

    Summary
    EudraCT number
    		 2013-004809-24
    Trial protocol
    		 GB  
    Global end of trial date
    16 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2026
    First version publication date
    18 Apr 2026
    Other versions
    Summary report(s)
    		 HOME PEPSE CSR_Feb22

    Trial information

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    Trial identification
    Sponsor protocol code
    RJF006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Julie Fox, Guy's & St. Thomas' NHS Foundation Trust, +44 02071882643, Julie.fox@kcl.ac.uk
    Scientific contact
    Julie Fox, Guy's & St. Thomas' NHS Foundation Trust, +44 02071882643, Julie.fox@kcl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To reduce the time to first dose of PEPSE in those accessing PEPSE following potential sexual exposure to HIV
    Protection of trial subjects
    Participants have the right to withdraw from the trial at any time for any reason. The investigator may also withdraw participants from the trial in the event of inter-current illness, adverse events, protocol violations, administrative reasons or other reasons. Particular attention will be made to those individuals who lose their Home PEPSE and or attend >5 times for Home PEPSE. Participants who miss two consecutive visits will be withdrawn from the trial. An excessive rate of withdrawals can render the trial impossible to interpret; therefore unnecessary withdrawal of participants should be avoided. Those withdrawing prior to week 24 will be replaced and new participants will be allocated to the same treatment arm as the individual who withdrew from the study. These new participants will start from baseline. Participants withdrawing from the trial will be asked to attend for a withdrawal visit. In all cases the date and reasons for withdrawal or withholding the dose of medication will be clearly stated on the participant’s eCRF. If the reason for removal of a participant from the trial is an adverse event or an abnormal laboratory test result, the principal specific event or test will be recorded on the eCRF.
    Background therapy
    		 Effectiveness of HIV postexposure prophylaxis (PEPSE) correlates with speed of uptake following HIV exposure. Time to first dose has not improved in the UK for over 10 years. On-demand pre-exposure prophylaxis (PrEP) has shown that people can self-start medication for HIV prevention. We hypothesised that advanced provision of PEPSE (HOME PEPSE) for men who have sex with men (MSM) to self- initiate would reduce time to first dose following HIV exposure.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 139
    Worldwide total number of subjects
    139
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    139
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 141 [1]
    Number of subjects completed
    		 139

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Using hypertensives: 1
    Reason: Number of subjects
    		 Deemed too high risk by investigator: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We do not count screening participants as enrolled
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is not a blinded study therefore patients and research team will know what arm the patient has been randomized to.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Immediate Home PEPSE arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Truvada® and Maraviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Truvada® (tenofovir disoproxil - as fumarate- 245 mg, emtricitabine 200 mg) ONE tablet once a day. Maraviroc 300 mg, TWO tablets once a day. The IMP should be taken with or after food.

    Arm title
    		 Arm B
    Arm description
    		 Deferred PEPSE arm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Truvada® and Maraviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Truvada® (tenofovir disoproxil - as fumarate- 245 mg, emtricitabine 200 mg) ONE tablet once a day. Maraviroc 300 mg, TWO tablets once a day. The IMP should be taken with or after food.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    69
    70
    Completed
    43
    39
    Not completed
    26
    31
         Consent withdrawn by subject
    6
    5
         Lost to follow-up
    -
    15
         HIV seroconversion
    -
    2
         Lost to follow-up
    12
    -
         Started PrEP
    8
    8
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Immediate Home PEPSE arm

    Reporting group title
    Arm B
    Reporting group description
    		 Deferred PEPSE arm

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 69 70 139
    Age categorical
    Units: Subjects
        < 25
    		 8 11 19
        ≥ 25
    		 58 58 116
        Not included - omitted
    		 3 1 4
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 66 69 135
        Not included - omitted
    		 3 1 4
    Ethnicity
    Units: Subjects
        White/Caucasian
    		 52 49 101
        Black or African
    		 4 5 9
        Oriental
    		 2 4 6
        Other
    		 8 11 19
        Not included - omitted
    		 3 1 4
    Employment status
    Units: Subjects
        Full time
    		 46 52 98
        Part time
    		 4 5 9
        Education
    		 11 9 20
        Unemployed
    		 5 3 8
        Not included - omitted
    		 3 1 4
    University degree
    Units: Subjects
        Degree held
    		 45 52 97
        Degree not held
    		 21 17 38
        Not included - omitted
    		 3 1 4
    Born in the UK
    Units: Subjects
        Born in the UK
    		 31 43 74
        Not Born in the UK
    		 35 26 61
        Not included - omitted
    		 3 1 4
    Relationship status
    Units: Subjects
        Not currently in the a relationship
    		 43 45 88
        Currently in a relationship
    		 23 24 47
        Not included - omitted
    		 3 1 4
    Circumcision
    Units: Subjects
        Curcumcised
    		 19 18 37
        Uncircumcised
    		 47 51 98
        Not included - omitted
    		 3 1 4
    PEPSE use in the past 12 months
    Units: Subjects
        PEPSE used in the past 12 months
    		 30 23 53
        PEPSE not used in the past 12 months
    		 36 46 82
        Not included - omitted
    		 3 1 4

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Immediate Home PEPSE arm

    Reporting group title
    Arm B
    Reporting group description
    		 Deferred PEPSE arm

    Primary: The median hours from HIV sexual risk exposure to initiating PEPSE over 48 weeks

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    End point title
    		 The median hours from HIV sexual risk exposure to initiating PEPSE over 48 weeks [1]
    End point description
    In those accessing PEPSE, the number of hours from HIV sexual risk exposure to initiating PEPSE over 48 weeks.
    End point type
    Primary
    End point timeframe
    From initiating PEPSE to 48 weeks after
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    22
    13
    Units: hours
        number (not applicable)
    7.3
    28.5
    No statistical analyses for this end point

    Secondary: The number of appropriate and inappropriate uses of Home PEPSE

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    End point title
    		 The number of appropriate and inappropriate uses of Home PEPSE
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation up to the 48-week endpoint
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    69
    70
    Units: times
        Appropriate use
    29
    15
        Inappropriate use
    4
    0
        Did not access PEP
    46
    56
        N/A - data not included
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Randomisation to 48 weeks after randomisation for Arm A
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 69 (0.00%)
         number of deaths (all causes)
    0
    5
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 69 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: SAEs breakdown not present in CSR

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2016
    Substantial Amendment [HOME PEPSE protocol v2.2 21/09/2016]
    24 Apr 2018
    Substantial Amendment Protocol v4.0

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36564186
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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