HIV InfectionsPhase 2NCT03259698
Optimizing the Delivery of HIV nPEP
A Phase 2 study testing nPEP, Text Messaging Support and Nurse-Led nPEP in people with HIV Infections, run by Unity Health Toronto at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- nPEP, Text Messaging Support and Nurse-Led nPEP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 3 sitesCanada
- Study dates
- 4 Nov 2021to Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Attia Qamar, BME contact
Canada3 sites, 3 recruiting
- Recruiting
HIV Prevention Clinic (Toronto General Hospital)
Toronto, Ontario
Karla Fisher, BSc, MSc, Karla.Fisher@uhn.ca
Isaac Bogoch, MD MS FRCPC
- Recruiting
Positive Care Clinic (St. Michael's Hospital)
Toronto, Ontario
Attia Qamar, BME, Attia.Qamar@unityhealth.to
Darrell Tan, MD FRCPC, PhD
- Recruiting
Crossways Sexual Health Clinic (TPH)
Toronto
Natalie Fawcett, BSN, MSN, NP, Natalie.Fawcett@toronto.ca
Allison Chris, MD CCFP FRCPC
About this study
Official title: 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:
Read more
- 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.
- Conditions
- HIV Infections
- Being tested
- nPEP, Text Messaging Support, Nurse-Led nPEP
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nPEPDrug
Also called Biktarvy, Bictegravir/emtricitabine/tenofovir alafenamide, BIC/FTC/TAF
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 SupportBehavioural
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 nPEPOther
nPEP follow-up is provided by nurse-led care at a local sexual health clinic instead of a hospital-based ID physician.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 = TEXT MESSAGING SUPPORT | Experimental | 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. Receives: Drug: nPEP; Behavioral: Text Messaging Support |
| ARM 2 = NO TEXT MESSAGING SUPPORT | Experimental | 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". Receives: Drug: nPEP |
| ARM 3 = NURSE-LED nPEP | Experimental | PEP will be delivered by a sexual health clinic nurse operating under a medical directive. Receives: Drug: nPEP; Other: Nurse-Led nPEP |
| ARM 4 = ID PHYSICIAN-LED nPEP, | Active comparator | PEP will be delivered according to the standard of care by an infectious diseases physician. Receives: Drug: nPEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (9)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP]
Collection of adverse events
Measured: 12 weeks
Completion of each scheduled follow-up activity (blood tests and clinic visits)
Measured by study visit attendance on CRFs
Measured: 12 weeks
Diagnosis of incident HIV
Determined through laboratory analysis of blood, urine and mucosal swab samples
Measured: 12 weeks
Sexually transmitted infections (gonorrhea, chlamydia, syphilis, hepatitis B and C)
Determined through laboratory analysis of blood sample
Measured: 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)
Measured: 12 weeks
Numbers and types of linkages made by PEP providers to other forms of healthcare
- Number of participants referred to psychiatry/mental health services and
- Number of participants referred to addictions/substance services
Measured: Week 12
Patient satisfaction with their PEP experience
Collected using a patient survey
Measured: 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
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start4 Nov 2021
- Primary completionDec 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CIHR Canadian HIV Trials Network
- Responsible party
- Sponsor
- Investigators
- Darrell HS Tan, MD, FRCPC, PhD, Principal investigator, Unity Health TorontoIsaac I Bogoch, MD, FRCPC, MSc, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259698
- Sponsor's protocol ID
- CTN 287
- Status last verified
- Nov 2021
- First submitted
- 21 Aug 2017
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32779730
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting
- ClinicalTrials.gov ID
- NCT03259698
- Acronym / sponsor ID
- CTN 287
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CIHR Canadian HIV Trials Network
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARM 1 = TEXT MESSAGING SUPPORT | Experimental | Drug: nPEP, Behavioral: Text Messaging SupportPEP 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 | Experimental | Drug: nPEPPEP 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 | Experimental | Drug: nPEP, Other: Nurse-Led nPEPPEP will be delivered by a sexual health clinic nurse operating under a medical directive. |
| ARM 4 = ID PHYSICIAN-LED nPEP, | Active comparator | Drug: nPEPPEP will be delivered according to the standard of care by an infectious diseases physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nPEPAlso: Biktarvy, Bictegravir/emtricitabine/tenofovir alafenamide, BIC/FTC/TAFParticipants 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. | Drug | ARM 1 = TEXT MESSAGING SUPPORT, ARM 2 = NO TEXT MESSAGING SUPPORT, ARM 3 = NURSE-LED nPEP, ARM 4 = ID PHYSICIAN-LED nPEP, |
| Text Messaging SupportText 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". | Behavioural | ARM 1 = TEXT MESSAGING SUPPORT |
| Nurse-Led nPEPnPEP follow-up is provided by nurse-led care at a local sexual health clinic instead of a hospital-based ID physician. | Other | ARM 3 = NURSE-LED nPEP |
Primary outcome
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
9 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP]
Time frame: 12 weeks
Completion of each scheduled follow-up activity (blood tests and clinic visits)
Time frame: 12 weeks
Diagnosis of incident HIV
Time frame: 12 weeks
Sexually transmitted infections (gonorrhea, chlamydia, syphilis, hepatitis B and C)
Time frame: 12 weeks
Self-reported sexual risk-taking behaviour
Time frame: 12 weeks
Numbers and types of linkages made by PEP providers to other forms of healthcare
Time frame: Week 12
Patient satisfaction with their PEP experience
Time frame: 12 weeks
Inquiries from participants to the PEP provider outside of scheduled follow-up
Time frame: 12 weeks
PEP-related referrals for physician consultation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Derived from this study: PubMed 32779730Palmer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attia Qamar, BME contact
Darrell HS Tan, MD, FRCPC, PhD principal investigator
Unity Health Toronto
Isaac I Bogoch, MD, FRCPC, MSc principal investigator
Toronto General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nPEP, Text Messaging Support and Nurse-Led nPEP in people with HIV Infections, run by Unity Health Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darrell HS Tan, MD, FRCPC, PhD (416-864-5568, darrell.tan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.