E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prevention of HIV infection |
HIV infectie preventie |
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E.1.1.1 | Medical condition in easily understood language |
prevention of HIV infection |
HIV infectie preventie |
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E.1.1.2 | Therapeutic area | Health Care [N] - Environment and Public Health [N06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the acceptability, feasibility and usability of an HIV
infection prevention program for high-risk MSM through 2 different biomedical
intervention strategies at the PHSA: daily Pre-exposure prophylaxis (PrEP) and intermittent Pre-exposure prophylaxis |
het onderzoeken van 2 verschillende (biomedische) interventie
strategieën m.b.t. acceptatie, uitvoerbaarheid en
gebruiksvriendelijkheid. |
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E.2.2 | Secondary objectives of the trial |
A. Adherence to medication
To assess the adherence of the participants to medication
and follow-up regimes
B. Side effects
To assess the incidence of serious adverse reactions attributable to the
medication
C. HIV infection
To assess the HIV incidence rate in the two project arms
D. Viral resistance
To assess HIV-drug resistance in case of incident HIV infection
E. Risk behaviour
To assess trends in sexual risk behaviour
F. STIs
To determine trends in incidence rate of STIs
G. Choice of strategy and its motivation
To identify determinants of choice of intervention and participant
satisfaction with their choice
H. General well-being
To assess self-perceived health and psychosocial well-being including
sexual health
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A. Therapietrouw: het onderzoeken van therapietrouw mbt het medicijn gebruik
B. Bijwerkingen: incidentie van bijwerkingen op de medicijnen
C. HIV infectie: de incidentie van HIV infecties in beide interventie armen
D. virale resistentie: he meten van resistentie bij tussentijdse hiv infectie
E. risico gedrag: het bepalen van trends in het rapporteren van seksueel risico gedrag
F. SOA: Het voorkomen van soa's in beide interventie armen
G. Keuze: het bepalen van determinanten op keuze van de interventie, en tevredenheid met keuze
H. Algemeen welbevinden: het bepalen van algemeen welbevinden inclusief gevoel van gezondheid en van seksule gezondheid en welbevinden
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or transgender, age 18 years or more
2. MSM
3. Completed HIV and STI screening
4. HIV negative by 4th generation Elisa antigen/antibody test.
5. Willing and able to comply to project visit schedule and procedures
6. Willing and able to give written informed consent
7. Sufficient understanding of Dutch or English
AND at least one of the following:
1. One or more documented STI (urethral or anal chlamydia or gonorrhoea, primary or secondary syphilis) in the last 6 months (either at STI clinic or a documented infection diagnosed elsewhere)
2. UAI with casual partners in the last 6 months
3. Received PEP after sexual risk incident in the last 6 months
4. HIV positive partner with unknown or detectable viral load
|
Alle hiernavolgende criteria
Man of transgender, 18 jaar of ouder
MSM
complete HIV en SOA screening ondergaan
HIV negatief met 4e generatie Elisa test
bereid om mee te doen en alle project procedures te ondergaan
informed concent gegeven
spreekt Engels of Nederlands
en 1 van de volgende criteria
een of meer vastgestelde soa (urethrale of anale chlamydia of gonorrhoe, of syphilis) in laatste 6 maanden
sex zonder condoom met losse partners in laatste 6 maanden
PEP na seks in laatste 6 maanden
HIV positieve partner met onbekende of detecteerbare viral load |
|
E.4 | Principal exclusion criteria |
1. Signs or symptoms of acute HIV infection1
2. Hepatitis B infection (i.e. HbsAg positive)
3. Creatinine clearing (using cockroft gault formula) < 60 ml/min
4. Hypersensitivity for one of the components of fixed combination tablet containing tenofovir and emtricitabine
5. Unlikely, in the opinion of the clinician, to comply with trial schedule
|
tekenen van akute HIV infectie
hepatitis B infectie
kreatinine klaring <60 ml/min
overgevoeligheid voor component van truvada
in de ogen van de arts of verpleegkundige niet waarschijnlijk dat deze persoon zich aan de procedures en voorschriften zal houden
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Uptake of each prevention intervention strategy
1a. Uptake per strategy among men who presented for screening
1b. Proportion of retained interventions, defined as proportion of enrolled people still in care and in intervention group of first choice, at 6, 12, 18 and 24 months, per strategy
1c. Proportion of enrolled people that switched project arm, per strategy
1d. Proportion of missed visits and proportion of participants that missed (definition: more than 2 weeks late for visit) one or more visits, per strategy
2. Acceptability
2a. Score on perceived and experienced agreeability of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
2b. Score on the perceived usefulness and effectiveness of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
2c. Score on the perceived and experienced disturbance by the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
2d. Proportion of participants that disclosed to others that they participate in this project
3. Usability
3a. Score on perceived and experienced ease of use of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
3b. Score on perceived and experienced clarity /complication of use of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
|
1 Het gebruik van elke preventie interventiestrategie
1a. Het gebruik per strategie onder de onder de gescreende personen
1b. Proportie van deelnemers die in behandeling is in de interventiegroep van hun eerste keuze op 6, 12, 18 en 24 maanden, per strategie
1c. Proportie van deelnemers die van projectarm is veranderd, per strategie
1d. proportie gemiste bezoeken en proportie van de deelnemers die een of meer bezoeken heeft gemist, per strategie
2 Acceptatie
2a. Score op waargenomen en ervaren plezierigheid van de gekozen ingreep als een persoonlijke HIV bescherming strategie (Likertschalen)
2b. Score op het ervaren nut en de effectiviteit van de gekozen interventie als een persoonlijke HIV bescherming strategie (Likertschalen)
2c. Score op de waargenomen en ervaren verstoring door de gekozen ingreep als een persoonlijke HIV bescherming strategie (Likertschalen)
2d. Percentage deelnemers dat bekend heeft gemaakt aan anderen dat ze deelnemen aan dit project
3 Bruikbaarheid
3a. Score op waargenomen en ervaren gebruiksgemak van de gekozen ingreep als een persoonlijke HIV bescherming strategie
3b. Score op waargenomen en ervaren helderheid / onduidelijkheid van het gebruik van de gekozen ingreep als een persoonlijke HIV bescherming strategie |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
A. Adherence
a. Daily PrEP group: proportion of correctly taken doses according to self-report, diary and pill-counts. Level of drug in blood samples
b. Intermittent PrEP group: proportion of correctly taken doses according to self-report, diary and pill-counts; median number of PrEP episodes per participant per year, proportion of correctly started PrEP episodes, proportion of correctely finished PrEP episodes.
B. Side effects
a. Both project arms: proportion of participants having adverse events
b. Both project arms : serious adverse events attributable to tenofovir or emtricitabine; adverse events that lead to interruption or cessation of tenofovir with emtricitabine; yearly change in renal function
C. Number of incident HIV infections
D. Viral resistance
a. Proportion of participants with incident HIV infection that has HIV drug resistance
b. Type of resistance mutations, proportion associated with tenofovir or emtricitabine
E. Changes in risk behaviour
a. Changes in number of sexual partners and type of sexual partner (steady or casual)
b. Changes in number of sex acts protected by condom
c. Changes in number and proportion of UAI sex acts with steady and with casual partners
F. Incidence rate of STIs (i.e., chlamydia, gonorrhoea, syphilis, hepatitis B and C)
G. Barriers and motives of choice
a. Anticipated barriers and motives per proposed strategy by open-end questionnaires at baseline
b. Experienced barriers and motives per proposed strategy, including rationale behind low scores of usability and acceptability (open end questionnaires; qualitative interviews in subsets), at follow-up
c. Rationale behind personal choice of intervention strategy by open end questionnaires, at baseline and at switch
d. Scores on anticipated and experienced level of self–efficacy per intervention strategy at baseline and follow-up
e. Scores on anticipated general satisfaction with chosen intervention regiment at baseline and actual satisfaction scores at 12 and 24 months
H. General well-being
a. Self-perceived health including sexual health, by questionnaire
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
evaluation of a demonstration project |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |