HIV Prevention With PrEP Among People on Opioid Replacement Therapy

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)

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.

OAT adherence through self-report and dispensing records (daily direct observed therapy and pill count for home supply)

Overall persistence, i.e.: PrEP taken at least once per week

Overall persistence, i.e.: OAT taken at least once per week

Comparing the number of individuals lost to follow-up between both groups

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.

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.

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.

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?

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?