Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the feasibility and acceptability of providing oral pre-exposure prophylaxis (PrEP) and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs operating in Alberta and Saskatchewan, to collect preference, adherence, and persistence data on oral PrEP, and to assess interest / acceptability of long-lasting injectable options for human immunodeficiency virus (HIV) prevention.
In Alberta and Saskatchewan, Canada, HIV acquisition is increasingly and predominantly seen in people who inject drugs (PWID). Less than 2% of this population are utilizing PrEP despite a high level of new infections. The purpose of this study is to assess the feasibility and acceptability of providing oral PrEP and OAT simultaneously in existing pharmacy-based programs operating in Alberta and Saskatchewan, to collect preference, adherence, and persistence data on oral PrEP, and to assess interest and acceptability of long-lasting injectable options for HIV prevention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP Group | Experimental | Participants who have agreed to be on PrEP |
|
| Non-PrEP Group | No Intervention | Participants who have declined PrEP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs | Behavioral | Simultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs |
| Measure | Description | Time Frame |
|---|---|---|
| Oral PrEP use in an OAT setting at 6 months follow-up: Review data from participant screening and clinical follow-up, and compare it to baseline PrEP use to assess uptake | The proportion of participants:
| Start of 6-month recruitment period to 6 months following the end of the recruitment period |
| Oral PrEP use in an OAT setting at 6 months follow-up: Record the time from offer to acceptance of PrEP | From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period |
| Measure | Description | Time Frame |
|---|---|---|
| Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months | PrEP adherence data will be collected via self-report and dispensing records (daily direct observed therapy and pill count for home supply). Unit of measure for PrEP adherence: Number of weeks in which PrEP prescription was filled. The proportion of participants adhering to PrEP will be compared between the PrEP and non-PrEP arms. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheldon M Chumir Health Centre | Not yet recruiting | Calgary | Alberta | T2R 0X7 | Canada |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months | OAT adherence through self-report and dispensing records (daily direct observed therapy and pill count for home supply) | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months | Overall persistence, i.e.: PrEP taken at least once per week | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months | Overall persistence, i.e.: OAT taken at least once per week | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| HIV incidence between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| STI incidence between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months | Comparing the number of individuals lost to follow-up between both groups | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as patient-reported outcome (PRO) measures | Qualitative measures assessed in all patient participants at baseline, 1, 3, 6, 9, and 12 months: HIV PrEP Stigma Scale (HPSS-12) Higher total scores reflect a higher level of perceived HIV-related stigma. Total scores range from 12 to 48. | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures | Qualitative measures assessed in all patient participants at baseline, 1, 3, 6, 9, and 12 months: Depression Scale (PHQ-9) Total scores range from 0 to 27. 0-4 indicates minimal or no depression, 5-9 suggests mild depression, 10-14 indicates moderate depression, 15-19 represents moderately severe depression, and 20-27 signifies severe depression. | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures | Qualitative measures assessed in all patient participants at baseline, 1, 3, 6, 9, and 12 months: Generalized Anxiety Disorder (GAD-7) Total scores are interpreted on a scale from 0 to 21, with higher scores indicating more severe anxiety. | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation |
| To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures | Qualitative measures will be assessed at baseline by interviewing OAT provider participants with questions regarding awareness of PrEP, barriers and facilitators of PrEP use, preferences for and acceptability of long-acting injectable options. Interview questions at Baseline visit:
| At initiation of PrEP |
| To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures | Qualitative measures will be assessed at 1, 3, 6, 9, and 12 months, by interviewing OAT provider participants with questions regarding awareness of PrEP, barriers and facilitators of PrEP use, preferences for and acceptability of long-acting injectable options. Interview questions at Follow-up visit:
| 1, 3, 6, 9, and 12 months after initiation of PrEP |
| Queen City Wellness Pharmacy | Not yet recruiting | Regina | Saskatchewan | S4P 0H7 | Canada |
|
| Mayfair Drugs Pharmacy | Recruiting | Saskatoon | Saskatchewan | S7L 0V8 | Canada |
|
| Pharmasave Riversdale Pharmacy | Recruiting | Saskatoon | Saskatchewan | S7M 0Y2 | Canada |
|
| The Medicine Shoppe Pharmacy | Recruiting | Saskatoon | Saskatchewan | S7M 0Z7 | Canada |
|
| Meadowgreen Pharmacy | Recruiting | Saskatoon | Saskatchewan | S7M 4R5 | Canada |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |