HIV Prevention With PrEP Among People on Opioid Replacement Therapy

Phase 4RecruitingNCT07160075

Cara Spence350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

350

Conditions

HIV - Human Immunodeficiency Virus

Interventions

Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programsBEHAVIORAL

Simultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Sheldon M Chumir Health Centre

Calgary, Alberta, Canada

NOT_YET_RECRUITING

Queen City Wellness Pharmacy

Regina, Saskatchewan, Canada

NOT_YET_RECRUITING

Mayfair Drugs Pharmacy

Saskatoon, Saskatchewan, Canada

Outcomes

Primary Outcomes

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: * 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)

Time frame: 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

Time frame: From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period

Secondary Outcomes

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.

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pharmasave Riversdale Pharmacy

Saskatoon, Saskatchewan, Canada

RECRUITING

The Medicine Shoppe Pharmacy

Saskatoon, Saskatchewan, Canada

RECRUITING

Meadowgreen Pharmacy

Saskatoon, Saskatchewan, Canada

RECRUITING

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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: * Before this study, how often would you recommend PrEP to patients at risk of HIV? * What do you think most of your patients' understanding of PrEP is? * Based on your estimates, what proportion of patients with HIV exposure are on PrEP in this community? * Why do you think is/are the reason(s) an eligible patient would decline PrEP? * In your experience, what are some effective ways to encourage eligible patients to take PrEP? * Do you believe health system barriers limit the uptake of PrEP in patients at risk of HIV? If so, what are they? * What are your opinions on prescribing a long-acting injectable option for PrEP over the oral version?

Time frame: 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: * Do you think your patients' understanding of PrEP has changed since the study began? If so, how? * Do you think your patients' attitudes towards PrEP has changed since the study began? If so, how? * What proportion of your patients do you predict will continue taking PrEP after the study ends? Why? * Have your opinions changed on prescribing long-acting injectables for PrEP over the oral version? If so, what is your current opinion and why? * Since the last questionnaire, do you have any additional comments on the patient-level and health system-level barriers and facilitators for PrEP uptake in this community?

Time frame: 1, 3, 6, 9, and 12 months after initiation of PrEP