Optimizing the Delivery of HIV nPEP
1 other identifier
interventional
434
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Nov 2021
Shorter than P25 for phase_2 hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedStudy Start
First participant enrolled
November 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedNovember 22, 2021
November 1, 2021
1.1 years
August 21, 2017
November 19, 2021
Conditions
Outcome Measures
Primary Outcomes (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
Determined by patient completion of acceptability questionnaire and evidence of HIV test result
12 weeks
Secondary Outcomes (9)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP]
12 weeks
Completion of each scheduled follow-up activity (blood tests and clinic visits)
12 weeks
Diagnosis of incident HIV
12 weeks
Sexually transmitted infections (gonorrhea, chlamydia, syphilis, hepatitis B and C)
12 weeks
Self-reported sexual risk-taking behaviour
12 weeks
- +4 more secondary outcomes
Other Outcomes (1)
Assessment of cost on heathcare system
Week 12
Study Arms (4)
ARM 1 = TEXT MESSAGING SUPPORT
EXPERIMENTALPEP 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.
ARM 2 = NO TEXT MESSAGING SUPPORT
EXPERIMENTALPEP will be delivered according to the standard of care by an infectious diseases physician. Participants will not receive text message reminders or "check-in".
ARM 3 = NURSE-LED nPEP
EXPERIMENTALPEP will be delivered by a sexual health clinic nurse operating under a medical directive.
ARM 4 = ID PHYSICIAN-LED nPEP,
ACTIVE COMPARATORPEP will be delivered according to the standard of care by an infectious diseases physician.
Interventions
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 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".
nPEP follow-up is provided by nurse-led care at a local sexual health clinic instead of a hospital-based ID physician.
Eligibility Criteria
You may qualify if:
- Be 18 years or older
- Be known or presumed to be HIV-uninfected at baseline
- 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
- 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
- Be capable of communicating verbally and via text in English
- 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).
- Be referred to a sexual assault center and provided with necessary counselling and support services if presented for nPEP following sexual assault.
You may not qualify if:
- Creatinine clearance \<30 mL/min (using Cockcroft-Gault formula)
- Enrolled in any other clinical trial of an HIV prevention intervention
- Prior participation in this clinical trial for a previous episode of nPEP
- Known co-infection with chronic hepatitis B at enrollment
- Current or planned pregnancy or breastfeeding
- 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)
- Concomitant use of HIV pre-exposure prophylaxis (PrEP)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Canadian Institutes of Health Research (CIHR)collaborator
- CIHR Canadian HIV Trials Networkcollaborator
Study Sites (3)
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
Related Publications (1)
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.
PMID: 32779730DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darrell HS Tan, MD, FRCPC, PhD
Unity Health Toronto
- PRINCIPAL INVESTIGATOR
Isaac I Bogoch, MD, FRCPC, MSc
Toronto General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2017
First Posted
August 24, 2017
Study Start
November 4, 2021
Primary Completion
December 1, 2022
Study Completion
August 1, 2023
Last Updated
November 22, 2021
Record last verified: 2021-11