Study Summary
This trial will test two ways to improve follow-up care for people taking post-exposure prophylaxis for HIV.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: Week 12
12 weeks
Completion of each scheduled follow-up activity (blood tests and clinic visits)
Diagnosis of incident HIV
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP]
Inquiries from participants to the PEP provider outside of scheduled follow-up
PEP-related referrals for physician consultation
Patient satisfaction with their PEP experience
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
Self-reported sexual risk-taking behaviour
Sexually transmitted infections (gonorrhea, chlamydia, syphilis, hepatitis B and C)
Week 12
Assessment of cost on heathcare system
Numbers and types of linkages made by PEP providers to other forms of healthcare
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
5 Treatment Groups
ARM 4 = ID PHYSICIAN-LED nPEP,
1 of 5
ARM 4 = ID PHYSICIAN-LED nPEP, NO TEXT MESSAGING SUPPORT
1 of 5
ARM 3 = NURSE-LED nPEP
1 of 5
ARM 1 = TEXT MESSAGING SUPPORT
1 of 5
ARM 2 = NO TEXT MESSAGING SUPPORT
1 of 5
Active Control
Experimental Treatment
434 Total Participants · 5 Treatment Groups
Primary Treatment: nPEP · No Placebo Group · Phase 2
ARM 3 = NURSE-LED nPEPExperimental Group · 2 Interventions: nPEP, Nurse-Led nPEP · Intervention Types: Drug, Other
ARM 1 = TEXT MESSAGING SUPPORTExperimental Group · 2 Interventions: nPEP, Text Messaging Support · Intervention Types: Drug, Behavioral
ARM 2 = NO TEXT MESSAGING SUPPORT
Drug
Experimental Group · 1 Intervention: nPEP · Intervention Types: DrugARM 4 = ID PHYSICIAN-LED nPEP,
Drug
ActiveComparator Group · 1 Intervention: nPEP · Intervention Types: DrugARM 4 = ID PHYSICIAN-LED nPEP, NO TEXT MESSAGING SUPPORTActiveComparator Group · 1 Intervention: ARM 4 = ID PHYSICIAN-LED nPEP, NO TEXT MESSAGING SUPPORT · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
494 Previous Clinical Trials
375,456 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,232 Previous Clinical Trials
24,675,218 Total Patients Enrolled
CIHR Canadian HIV Trials NetworkNETWORK
39 Previous Clinical Trials
4,499 Total Patients Enrolled
Allison Chris, MD, FRCPC, CCFPPrincipal InvestigatorToronto Public Health
Isaac I Bogoch, MD, FRCPC, MScPrincipal InvestigatorToronto General Hospital
Darrell HS Tan, MD, FRCPC, PhDPrincipal InvestigatorUnity Health Toronto
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If someone is presenting for nPEP after a sexual assault, they should be referred to a sexual assault center for necessary counseling and support services.
If you have been exposed to HIV within the past six days, your healthcare provider can initiate you on PEP (post-exposure prophylaxis) to help reduce your risk of becoming infected.
A person needs to own a mobile phone that has text messaging capabilities and be willing to potentially receive messages from a text messaging service.
I can communicate verbally and via text in English.
If you are planning to continue your follow-up locally, you will need to be willing to have follow-up study visits conducted remotely
to purchase tobacco products
You must be 18 years or older to purchase tobacco products.
Baseline means the time at which the study begins.
References
- Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fønhus 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:CD013680. doi: 10.1002/14651858.CD013680.
- 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.
- 2021. "Optimizing the Delivery of HIV nPEP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03259698.
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Conditions
Cancer Related
Treatments