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Optimizing the Delivery of HIV nPEP

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ClinicalTrials.gov Identifier: NCT03259698
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:

Despite decades of traditional prevention efforts based on behavior change and condom use, Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure prophylaxis (PEP) is one such approach, in which uninfected persons use 28 days of antiretroviral medications (ARVs) shortly after an HIV exposure to minimize the risk of acquiring HIV. PEP is highly efficacious, is considered a standard of care intervention based on medical and ethical grounds, and is supported by treatment guidelines. Yet several implementation challenges have limited its clinical and public health impact in Ontario, where no formal PEP policy exists. Our proposal seeks to optimize two aspects of delivering PEP for sexual exposures (nPEP). Results will inform the development of a standardized approach to nPEP both province-wide and elsewhere.

Thus study has pragmatic, multicenter randomized controlled trial using a 2x2 factorial design to determine whether the proportion of nPEP patients that successfully complete follow-up:

  1. is higher among those receiving mobile phone-based text messaging support than among those receiving standard care; and
  2. is non-inferior among those receiving care from a sexual health clinic nurse compared to those receiving hospital-based physician care.

The prospective, randomized, non-blinded, 2x2 factorial trial that will enroll 358 study participants in Toronto and Ottawa. In Intervention A, we will randomize half of study participants to a text messaging support service ('WelTel'), in which a trained, community-based research staff person provides standardized weekly 'check-in' messages during their 12-week course of PEP follow-up. The other half will receive standard care, which does not include any form of active outreach or reminders outside of scheduled appointments. In Intervention B, we will randomize half of participants to receive nurse-led care for PEP follow-up at a local sexual health clinic; the other half will receive standard care by a hospital-based ID physician. The specific activities for each follow-up visit will be clearly defined in a medical directive. In keeping with Ontario legislation on medical directives, nurses will review cases with their authorizing physician or nurse practitioner on a routine basis.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: nPEP Behavioral: Text Messaging Support Other: Nurse-Led nPEP Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: ARM 1 = NURSE-LED nPEP, TEXT MESSAGING SUPPORT
PEP will be delivered by a sexual health clinic nurse operating under a medical directive, and participants will receive weekly text message "check-ins" via the WelTel system.
Drug: nPEP

Toronto participants will receive tenofovir alafenamide/emtricitabine/elvitegravir/cobicistat 10/200/150/150 mg (Genvoya) one tablet once daily as study drug to complete a 28 day course of PEP.

Ottawa participants will receive PEP medications outside of the trial in the form of tenofovir disoproxil fumarate/emtricitabine 300/200 mg (Truvada) once daily + raltegravir (Isentress) 400 mg twice daily to complete a 28 day course.

Other Names:
  • Genvoya
  • Truvada
  • Isentress

Behavioral: Text Messaging Support
Text messaging support service ('WelTel'): community-based research staff person provides standardized weekly 'check-in' messages during their 12-week course of nPEP follow-up.

Other: Nurse-Led nPEP
nPEP follow-up is provided by nurse-led care at a local sexual health clinic instead of a hospital-based ID physician.

Experimental: ARM 2 = ID PHYSICIAN-LED nPEP, TEXT MESSAGING SUPPORT
PEP will be delivered according to the standard of care by an infectious diseases physician, and participants will receive weekly text message "check-ins" via the WelTel system.
Drug: nPEP

Toronto participants will receive tenofovir alafenamide/emtricitabine/elvitegravir/cobicistat 10/200/150/150 mg (Genvoya) one tablet once daily as study drug to complete a 28 day course of PEP.

Ottawa participants will receive PEP medications outside of the trial in the form of tenofovir disoproxil fumarate/emtricitabine 300/200 mg (Truvada) once daily + raltegravir (Isentress) 400 mg twice daily to complete a 28 day course.

Other Names:
  • Genvoya
  • Truvada
  • Isentress

Behavioral: Text Messaging Support
Text messaging support service ('WelTel'): community-based research staff person provides standardized weekly 'check-in' messages during their 12-week course of nPEP follow-up.

Experimental: ARM 3 = NURSE-LED nPEP, NO TEXT MESSAGING SUPPORT
PEP will be delivered by a sexual health clinic nurse operating under a medical directive, and participants will not receive any additional outreach beyond the usual standard of care.
Drug: nPEP

Toronto participants will receive tenofovir alafenamide/emtricitabine/elvitegravir/cobicistat 10/200/150/150 mg (Genvoya) one tablet once daily as study drug to complete a 28 day course of PEP.

Ottawa participants will receive PEP medications outside of the trial in the form of tenofovir disoproxil fumarate/emtricitabine 300/200 mg (Truvada) once daily + raltegravir (Isentress) 400 mg twice daily to complete a 28 day course.

Other Names:
  • Genvoya
  • Truvada
  • Isentress

Other: Nurse-Led nPEP
nPEP follow-up is provided by nurse-led care at a local sexual health clinic instead of a hospital-based ID physician.

Active Comparator: ARM 4 = ID PHYSICIAN-LED nPEP, NO TEXT MESSAGING SUPPORT
PEP will be delivered according to the standard of care by an infectious diseases physician, and participants will not receive any additional outreach beyond the usual standard of care.
Drug: nPEP

Toronto participants will receive tenofovir alafenamide/emtricitabine/elvitegravir/cobicistat 10/200/150/150 mg (Genvoya) one tablet once daily as study drug to complete a 28 day course of PEP.

Ottawa participants will receive PEP medications outside of the trial in the form of tenofovir disoproxil fumarate/emtricitabine 300/200 mg (Truvada) once daily + raltegravir (Isentress) 400 mg twice daily to complete a 28 day course.

Other Names:
  • Genvoya
  • Truvada
  • Isentress




Primary Outcome Measures :
  1. Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure [ Time Frame: 12 weeks ]
    Determined by patient completion of acceptability questionnaire and evidence of HIV test result


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP] [ Time Frame: 12 weeks ]
    Collection of adverse events

  2. Completion of each scheduled follow-up activity (blood tests and clinic visits) [ Time Frame: 12 weeks ]
    Measured by study visit attendance on CRFs

  3. Diagnosis of incident HIV [ Time Frame: 12 weeks ]
    Determined through laboratory analysis of blood, urine and mucosal swab samples

  4. Sexually transmitted infections (gonorrhea, chlamydia, syphilis, hepatitis B and C) [ Time Frame: 12 weeks ]
    Determined through laboratory analysis of blood sample

  5. Self-reported sexual risk-taking behaviour [ Time Frame: 12 weeks ]
    The following activities will be captured in a questionnaire: number of unprotected vaginal/anal sex acts, and for men who have sex with men, score on a validated HIV risk index (HIRI-MSM)

  6. Numbers and types of linkages made by PEP providers to other forms of healthcare [ Time Frame: Week 12 ]
    1. Number of participants referred to psychiatry/mental health services and
    2. Number of participants referred to addictions/substance services

  7. Patient satisfaction with their PEP experience [ Time Frame: 12 weeks ]
    Collected using a patient survey

  8. Inquiries from participants to the PEP provider outside of scheduled follow-up [ Time Frame: 12 weeks ]
    the number of times participants contacted their healthcare provider outside of scheduled follow-up

  9. PEP-related referrals for physician consultation [ Time Frame: 12 weeks ]
    Number of times a participant randomized to the nurse-led arm had to be referred to a physician; captured on the sexual health clinic documentation.


Other Outcome Measures:
  1. Assessment of cost on heathcare system [ Time Frame: Week 12 ]
    Prospective collection of cost data during the trial to inform a future health economic analysis from the perspective of the healthcare system.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be 18 years or older
  2. Be known or presumed to be HIV-uninfected at baseline
  3. Be initiated on PEP by a healthcare provider in the past six days for a sexual exposure to a known or suspected HIV-infected source
  4. Own a mobile phone with text messaging capabilities on which they are willing to potentially receive messages from the text messaging service
  5. Be capable of communicating verbally and via text in English
  6. Be planning to continue their follow-up locally

Exclusion Criteria:

  1. Concomitant use of any prescription medication at the time of PEP initiation (except antibiotics for co-incident sexually transmitted infections), unless the site is providing an alternative, standard of care regimen without drug interactions such as TDF/FTC/RAL outside the clinical trial
  2. Concomitant use of any non-prescription supplement, vitamin or natural remedy which the patient is unwilling to discontinue during the 28 days of PEP administration, unless the site is providing an alternative, standard of care regimen without drug interactions such as TDF/FTC/RAL outside the clinical trial
  3. Creatinine clearance <30 mL/min (using Cockcroft-Gault formula) if the participant is using TAF/FTC/ELV/cobi, or <60 mL/min if the participant is using TDF/FTC/RAL
  4. Enrolled in any other clinical trial of an HIV prevention intervention
  5. Prior participation in this clinical trial for a previous episode of nPEP
  6. Known co-infection with chronic hepatitis B at enrollment
  7. Current or planned pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259698


Contacts
Contact: Darrell HS Tan, MD, FRCPC, PhD 416-864-5568 darrell.tan@gmail.com
Contact: Jasmine Lee LeeJasm@smh.ca

Locations
Canada, Ontario
HIV Prevention Clinic (Toronto General Hospital) Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Isaac Bogoch, MD MS FRCPC         
Positive Care Clinic (St. Michael's Hospital) Not yet recruiting
Toronto, Ontario, Canada
Contact: Jasmine Lee         
Principal Investigator: Darrell Tan, MD FRCPC, PhD         
Canada
Division of Infectious Diseases (Ottawa General Hospital) Not yet recruiting
Ottawa, Canada
Contact: Chris Hnain         
Principal Investigator: Paul MacPherson, PhD MD FRCPC         
Sexual Health Centre (OPH) Not yet recruiting
Ottawa, Canada
Contact: Patrick O'Byrne         
Principal Investigator: Nicole Sherling, MD         
Crossways Sexual Health Clinic (TPH)
Toronto, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Darrell HS Tan, MD, FRCPC, PhD St. Michael's Hospital, Toronto
Principal Investigator: Isaac I Bogoch, MD St. Michael's Hospital, Toronto

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03259698     History of Changes
Other Study ID Numbers: CTN 287
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action