Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
434 participants
INTERVENTIONAL
2021-11-04
2023-08-31
Brief Summary
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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 318 study participants in Toronto. In Intervention A, we will randomize half of study participants to a text messaging support service ('WelTel'), in which a trained, community-based counselor 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ARM 1 = TEXT MESSAGING SUPPORT
PEP will be delivered by ID physician and participants will receive weekly text message "check-ins" and optional automated text appointment reminders via the WelTel system.
nPEP
Participants will receive Bictegravir/emtricitabine/tenofovir alafenamide 50/200/25mg (Biktarvy®) one tablet once daily as study drug to complete a 28 day course of PEP.
Text Messaging Support
Text messaging support service ('WelTel'): community-based counselors will provides standardized weekly 'check-in' messages during the participants 12-week course of nPEP follow-up. Participants in the text-message arm will also have the option of receiving generic non-specific automated text reminders of their upcoming appointments in the form of "Don't forget about tomorrow".
ARM 2 = NO TEXT MESSAGING SUPPORT
PEP will be delivered according to the standard of care by an infectious diseases physician. Participants will not receive text message reminders or "check-in".
nPEP
Participants will receive Bictegravir/emtricitabine/tenofovir alafenamide 50/200/25mg (Biktarvy®) one tablet once daily as study drug to complete a 28 day course of PEP.
ARM 3 = NURSE-LED nPEP
PEP will be delivered by a sexual health clinic nurse operating under a medical directive.
nPEP
Participants will receive Bictegravir/emtricitabine/tenofovir alafenamide 50/200/25mg (Biktarvy®) one tablet once daily as study drug to complete a 28 day course of PEP.
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.
ARM 4 = ID PHYSICIAN-LED nPEP,
PEP will be delivered according to the standard of care by an infectious diseases physician.
nPEP
Participants will receive Bictegravir/emtricitabine/tenofovir alafenamide 50/200/25mg (Biktarvy®) one tablet once daily as study drug to complete a 28 day course of PEP.
Interventions
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nPEP
Participants will receive Bictegravir/emtricitabine/tenofovir alafenamide 50/200/25mg (Biktarvy®) one tablet once daily as study drug to complete a 28 day course of PEP.
Text Messaging Support
Text messaging support service ('WelTel'): community-based counselors will provides standardized weekly 'check-in' messages during the participants 12-week course of nPEP follow-up. Participants in the text-message arm will also have the option of receiving generic non-specific automated text reminders of their upcoming appointments in the form of "Don't forget about tomorrow".
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. STAGE 1 only: 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 or be willing to have follow-up study visits conducted remotely; either by telephone or via an encrypted video conferencing system (such as Zoom for healthcare).
7. Be referred to a sexual assault center and provided with necessary counselling and support services if presented for nPEP following sexual assault.
Exclusion Criteria
2. Enrolled in any other clinical trial of an HIV prevention intervention
3. Prior participation in this clinical trial for a previous episode of nPEP
4. Known co-infection with chronic hepatitis B at enrollment
5. Current or planned pregnancy or breastfeeding
6. Use of a medication whose co-administration with Biktarvy is contraindicated (dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifampicin, rifabutin, rifapentine, modafinil, dexamethasone, metformin, St. John's Wort)
7. Concomitant use of HIV pre-exposure prophylaxis (PrEP)
8. Stage 2 only: Concomitant use of any non-prescription medication, supplement, vitamin or natural remedy which the patient is unwilling to discontinue during Biktarvy® administration
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
CIHR Canadian HIV Trials Network
NETWORK
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Darrell HS Tan, MD, FRCPC, PhD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Isaac I Bogoch, MD, FRCPC, MSc
Role: PRINCIPAL_INVESTIGATOR
Toronto General Hospital
Locations
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HIV Prevention Clinic (Toronto General Hospital)
Toronto, Ontario, Canada
Positive Care Clinic (St. Michael's Hospital)
Toronto, Ontario, Canada
Crossways Sexual Health Clinic (TPH)
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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Karla Fisher, BSc, MSc
Role: primary
Attia Qamar, BME
Role: primary
Natalie Fawcett, BSN, MSN, NP
Role: primary
References
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Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
Other Identifiers
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CTN 287
Identifier Type: -
Identifier Source: org_study_id