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Completed

NCT Number: NCT02149888

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tenofovir/Emtricitabine

Drug

Once daily Tenofovir/emtricitabine (Truvada®)

Other names: Truvada®

Primary outcomes

  1. Participants' self-reported overall acceptability of PrEP

    Time frame: 12 months

    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.

  2. The level of community interest in PrEP

    Time frame: 12 months

    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

Secondary outcomes

  1. Adherence to daily TDF/FTC-based PrEP

    Time frame: 12 months

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

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

    Time frame: 12 months

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

  3. HIV infection

    Time frame: 12 months

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

  4. Sexually transmitted infections

    Time frame: 12 months

    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.

  5. Burden of syndemic health problems

    Time frame: 12 months

    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.

  6. Change in estimated glomerular filtration rate

    Time frame: 12 months

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

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

    Time frame: 12 months

  8. Adverse events

    Time frame: 12 months

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

  9. Pilot testing study instruments

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • AIDS Committee of Toronto
  • Canadian AIDS Treatment Information Exchange
  • Gilead Sciences
  • Hassle Free Clinic
  • Maple Leaf Research
  • Toronto Metropolitan University

Registry information

Official study title

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

Acronym: PREP-5

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 29, 2014
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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