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

HIV Clinical Trial

— PREP-5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149888
• Other study ID #: PREPARATORY-5
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2014
• Last updated: October 14, 2016
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Tenofovir/emtricitabine
Once daily Tenofovir/emtricitabine (Truvada®)

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	AIDS Committee of Toronto, Canadian AIDS Treatment Information Exchange, Gilead Sciences, Hassle Free Clinic, Maple Leaf Medical Clinic, Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Primary	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	12 months	No
Secondary	Adherence to daily TDF/FTC-based PrEP	Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.	12 months	No
Secondary	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.	12 months	No
Secondary	HIV infection	HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.	12 months	No
Secondary	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.	12 months	No
Secondary	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.	12 months	No
Secondary	Change in estimated glomerular filtration rate	Estimated by the Modified Diet in Renal Disease (MDRD) formula	12 months	Yes
Secondary	Percentage change in bone mineral density at the lumbar spine and total hip		12 months	Yes
Secondary	Adverse events	Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).	12 months	Yes
Secondary	Pilot testing study instruments	Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure	12 months	No