- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02149888
PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5 (PREP-5)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Tenofovir/emtricitabine
MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
|
Once daily Tenofovir/emtricitabine (Truvada®)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Participants' self-reported overall acceptability of PrEP
Délai: 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.
|
12 months
|
The level of community interest in PrEP
Délai: 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
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adherence to daily TDF/FTC-based PrEP
Délai: 12 months
|
Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.
|
12 months
|
Time required by the patient, physician and research coordinator for each type of study visit.
Délai: 12 months
|
The time required by the patient, physician and research coordinator will be measured for each type of study visit.
|
12 months
|
HIV infection
Délai: 12 months
|
HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.
|
12 months
|
Sexually transmitted infections
Délai: 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.
|
12 months
|
Burden of syndemic health problems
Délai: 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.
|
12 months
|
Change in estimated glomerular filtration rate
Délai: 12 months
|
Estimated by the Modified Diet in Renal Disease (MDRD) formula
|
12 months
|
Percentage change in bone mineral density at the lumbar spine and total hip
Délai: 12 months
|
12 months
|
|
Adverse events
Délai: 12 months
|
Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).
|
12 months
|
Pilot testing study instruments
Délai: 12 months
|
Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure
|
12 months
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Maladies du système immunitaire
- Maladies à virus lents
- Infections à VIH
- Syndrome immunodéficitaire acquis
- Syndromes d'immunodéficience
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Inhibiteurs de la transcriptase inverse
- Inhibiteurs de la synthèse des acides nucléiques
- Inhibiteurs d'enzymes
- Agents anti-VIH
- Agents antirétroviraux
- Ténofovir
- Emtricitabine
Autres numéros d'identification d'étude
- PREPARATORY-5
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur VIH
-
Icahn School of Medicine at Mount SinaiIRRASRecrutementHémorragie intraventriculaire (HIV)États-Unis
-
Yale UniversityComplétéPrématurité | Nourrissons de très faible poids à la naissance | Hémorragie intraventriculaire (HIV) | Saignement dans le cerveauÉtats-Unis
Essais cliniques sur Tenofovir/emtricitabine
-
Bristol-Myers SquibbComplétéInfections à VIHChili, Le Portugal, Espagne, Italie, États-Unis, Argentine, Australie, L'Autriche, Belgique, Brésil, Canada, Colombie, Costa Rica, République Dominicaine, France, Allemagne, Guatemala, Hong Kong, Indonésie, Mexique, Pays-Bas, Panama, Péro... et plus