- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03259698
Optimizing the Delivery of HIV nPEP
Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting
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:
- is higher among those receiving mobile phone-based text messaging support than among those receiving standard care; and
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Darrell HS TAN, MD, FRCPC, PhD
- Phone Number: 416-864-5568
- Email: darrell.tan@gmail.com
Study Contact Backup
- Name: Attia Qamar, BME
- Email: Attia.Qamar@unityhealth.to
Study Locations
-
-
-
Toronto, Canada
- Recruiting
- Crossways Sexual Health Clinic (TPH)
-
Contact:
- Natalie Fawcett, BSN, MSN, NP
- Email: Natalie.Fawcett@toronto.ca
-
Principal Investigator:
- Allison Chris, MD CCFP FRCPC
-
-
Ontario
-
Toronto, Ontario, Canada
- Recruiting
- HIV Prevention Clinic (Toronto General Hospital)
-
Contact:
- Karla Fisher, BSc, MSc
- Email: Karla.Fisher@uhn.ca
-
Principal Investigator:
- Isaac Bogoch, MD MS FRCPC
-
Toronto, Ontario, Canada
- Recruiting
- Positive Care Clinic (St. Michael's Hospital)
-
Contact:
- Attia Qamar, BME
- Email: Attia.Qamar@unityhealth.to
-
Principal Investigator:
- Darrell Tan, MD FRCPC, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
Other Names:
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".
|
EXPERIMENTAL: 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".
|
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.
Other Names:
|
EXPERIMENTAL: ARM 3 = NURSE-LED nPEP
PEP will be delivered by a sexual health clinic nurse operating under a medical directive.
|
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.
Other Names:
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,
PEP will be delivered according to the standard of care by an infectious diseases physician.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP]
Time Frame: 12 weeks
|
Collection of adverse events
|
12 weeks
|
Completion of each scheduled follow-up activity (blood tests and clinic visits)
Time Frame: 12 weeks
|
Measured by study visit attendance on CRFs
|
12 weeks
|
Diagnosis of incident HIV
Time Frame: 12 weeks
|
Determined through laboratory analysis of blood, urine and mucosal swab samples
|
12 weeks
|
Sexually transmitted infections (gonorrhea, chlamydia, syphilis, hepatitis B and C)
Time Frame: 12 weeks
|
Determined through laboratory analysis of blood sample
|
12 weeks
|
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 HIV risk index (based on the validated HIRI-MSM)
|
12 weeks
|
Numbers and types of linkages made by PEP providers to other forms of healthcare
Time Frame: Week 12
|
|
Week 12
|
Patient satisfaction with their PEP experience
Time Frame: 12 weeks
|
Collected using a patient survey
|
12 weeks
|
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
|
12 weeks
|
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.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isaac I Bogoch, MD, FRCPC, MSc, Toronto General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
- Emtricitabine tenofovir alafenamide
Other Study ID Numbers
- CTN 287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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