HIV - Human Immunodeficiency Virus
Conditions
Keywords
PrEP, OAT, Opioid Agonist Therapy, HIV
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSimultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
Simultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs
Sponsors
Gilead Sciences
Cara Spence
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* HIV negative * Ongoing behaviors with potential HIV exposure as assessed by a clinician * Regularly engaged with their respective OAT program at least 3 days a week for the past 2 weeks * Report willingness to return for follow-up visits
Exclusion criteria
* Creatine clearance \<30 mL/min or any medical condition or medication known to be contraindicated with the use of Emtricitabine/Tenofovir Alafenamide (F/TAF) or Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) * Taken PrEP within the last 24 hours at the time of screening or enrollment * Deemed appropriate by a clinician for HIV Post-Exposure Prophylaxis at the time of screening or enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Start of 6-month recruitment period to 6 months following the end of the recruitment period | The proportion of participants: * Using PrEP within the clinical programs at baseline * Who initiate PrEP (take one dose) when approached for study enrollment and 1, 3, and 6 months from study initiation * Maintained on PrEP at 6 months (have taken PrEP at least once a week) |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation | 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. |
| To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation | 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. |
| 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 | From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation | 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. |
| 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 | — |
Countries
Canada
Outcome results
None listed