A Phase 2 interventional study of nPEP and Text Messaging Support in HIV Infections, sponsored by Unity Health Toronto. Status unknown at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Unity Health Toronto · Phase 2, Interventional, and Treatment
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:
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.
Exclusion Criteria:
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.
Drug: nPEP · Behavioral: 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".
Drug: nPEP
PEP will be delivered by a sexual health clinic nurse operating under a medical directive.
Drug: nPEP · Other: Nurse-Led nPEP
PEP will be delivered according to the standard of care by an infectious diseases physician.
Drug: 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.
Also known as: Biktarvy, Bictegravir/emtricitabine/tenofovir alafenamide, BIC/FTC/TAF
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.
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
Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP]
Collection of adverse events
Time frame: 12 weeks
Completion of each scheduled follow-up activity (blood tests and clinic visits)
Measured by study visit attendance on CRFs
Time frame: 12 weeks
Diagnosis of incident HIV
Determined through laboratory analysis of blood, urine and mucosal swab samples
Time frame: 12 weeks
Sexually transmitted infections (gonorrhea, chlamydia, syphilis, hepatitis B and C)
Determined through laboratory analysis of blood sample
Time frame: 12 weeks
Self-reported sexual risk-taking behaviour
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)
Time frame: 12 weeks
Numbers and types of linkages made by PEP providers to other forms of healthcare
1. Number of participants referred to psychiatry/mental health services and 2. Number of participants referred to addictions/substance services
Time frame: Week 12
Patient satisfaction with their PEP experience
Collected using a patient survey
Time frame: 12 weeks
Inquiries from participants to the PEP provider outside of scheduled follow-up
the number of times participants contacted their healthcare provider outside of scheduled follow-up
Time frame: 12 weeks
PEP-related referrals for physician consultation
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.
Time frame: 12 weeks
Assessment of cost on heathcare system
Prospective collection of cost data during the trial to inform a future health economic analysis from the perspective of the healthcare system.
Time frame: Week 12
Plan to share: Undecided
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Unity Health Toronto