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HIVPhase 4PREP-5NCT02149888

PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5

A Phase 4 study testing Tenofovir/emtricitabine in people with HIV and Human Immunodeficiency Virus, run by Unity Health Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel biomedical approach to HIV prevention shown in… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV, Human Immunodeficiency Virus
What is being tested?
Tenofovir/emtricitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteCanada
Study dates
Oct 2014to Jun 2016
Phase
Phase 4
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
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Self-identified man who has sex with men
  • Age 18 years or older
  • Able to communicate in both written and oral english
  • HIRI-MSM score greater than or equal to 10
  • At least one self-reported unprotected receptive anal sex act over the preceding 6 months
  • Creatinine clearance greater than or equal to 60mL/min by Modified Diet in Renal Disease (MDRD) formula
  • HIV un-infected at screening using standard ELISA and Western Blot testing

Who cannot join

  • Clinical signs or symptoms suggestive of an HIV seroconversion illness within the last 3 months in the opinion of the investigator
  • Use of pre- or post-exposure prophylaxis within the last 3 months
  • Use of concomitant nephrotoxic drugs
  • Use of concomitant immune modulatory drugs
  • Hepatitis B surface antigen positivity
  • Any condition or concomitant medication portending an increased risk of osteoporosis
  • Enrollment in any other HIV prevention program or trial

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study

Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel biomedical approach to HIV prevention shown in the iPrEx trial to be safe and efficacious in reducing HIV acquisition by 44% among MSM, when provided in a comprehensive package of HIV prevention interventions including counseling, testing/treatment of sexually transmitted infections (STIs), and condoms. There is now widespread mobilization to assess the feasibility of PrEP roll-out worldwide, with urgent calls for 'demonstration projects' addressing real-world PrEP implementation issues.

PREPARATORY-5 is Canada's first PrEP demonstration project, and will examine real-world PrEP implementation issues including acceptability, effectiveness, impact on sexually transmitted infections, and strategies for supporting adherence outside the clinical trial setting. The investigators have also established a comprehensive community-based research program investigating the role of community-based organizations in PrEP implementation and delivery.

Being tested
Tenofovir/emtricitabine
Keywords
HIV, Pre-Exposure Prophylaxis, PrEP, Human Immunodeficiency Virus
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenofovir/emtricitabineDrug

    Also called Truvada®

    Once daily Tenofovir/emtricitabine (Truvada®)

Study groups in NCT02149888
Study groupRoleWhat they receive
Tenofovir/emtricitabineExperimentalMSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
Receives: Drug: Tenofovir/emtricitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants' self-reported overall acceptability of PrEP

    Participants' self-reported overall acceptability of PrEP over the full one-year follow-up period (including the use of the medication, clinic visits, and their impact on the participant's life) will be quantified using a Likert scale.

    Measured: 12 months

  2. The level of community interest in PrEP

    The level of community interest in PrEP will be measured by quantifying the volume, rate and HIV risk levels of patient referrals to the PrEP clinic from each key referral source

    Measured: 12 months

Secondary outcomes (9)

  1. Adherence to daily TDF/FTC-based PrEP

    Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.

    Measured: 12 months

  2. Time required by the patient, physician and research coordinator for each type of study visit.

    The time required by the patient, physician and research coordinator will be measured for each type of study visit.

    Measured: 12 months

  3. HIV infection

    HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.

    Measured: 12 months

  4. Sexually transmitted infections

    Testing will be performed at each study visit to screen for gonorrhea, chlamydia and syphilis infection, including pharyngeal swab cultures, rectal swab cultures and urine NAAT tests.

    Measured: 12 months

  5. Burden of syndemic health problems

    The burden of specific syndemic health problems (depression, social anxiety, substance abuse, sexual addiction, childhood sexual abuse, partner violence) will be quantified using standardized, validated psychometric tools.

    Measured: 12 months

  6. Change in estimated glomerular filtration rate

    Estimated by the Modified Diet in Renal Disease (MDRD) formula

    Measured: 12 months

  7. Percentage change in bone mineral density at the lumbar spine and total hip

    Measured: 12 months

  8. Adverse events

    Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).

    Measured: 12 months

  9. Pilot testing study instruments

    Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02149888
Sponsor's protocol ID
PREPARATORY-5
Acronym
PREP-5
Status last verified
Oct 2016
First submitted
12 May 2014
Last updated
17 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Tan DHS, Schnubb A, Lawless J, Szadkowski L, Grennan T, Wilton J, Fowler S, Hart TA, Maxwell J, Raboud JM. Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. CMAJ Open. 2018 Dec 10;6(4):E611-E617. doi: 10.9778/cmajo.20180068. Print 2018 Oct-Dec.

    PubMed 30530721

  • Wilton J, Noor SW, Schnubb A, Lawless J, Hart TA, Grennan T, Fowler S, Maxwell J, Tan DHS. High HIV risk and syndemic burden regardless of referral source among MSM screening for a PrEP demonstration project in Toronto, Canada. BMC Public Health. 2018 Feb 27;18(1):292. doi: 10.1186/s12889-018-5180-8.

    PubMed 29486737

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenofovir/emtricitabine in people with HIV and Human Immunodeficiency Virus, run by Unity Health Toronto at 1 site 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 7 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: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants' self-reported overall acceptability of PrEP (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02149888, which also lists 2 linked publications.

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 17 Oct 2016.

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