Pre-exposure Prophylaxis (PrEP) for People Who Inject Drugs (PWID)

Study Overview
=================
Brief Summary
-----------------
People who inject drugs (PWID) experience high risk of HIV acquisition. Antiretroviral pre-exposure prophylaxis (PrEP) is an efficacious biomedical HIV prevention strategy for high risk HIV-uninfected individuals including PWID, yet uptake has been low in this population and uptake and adherence interventions have not been developed or tested. Drawing from formative qualitative research, the overall goal of this project is to develop an intervention to promote PrEP uptake and adherence among PWID in the U.S. Northeast. The investigators will: Analyze existing literature and data to identify specific barriers and facilitators to PrEP uptake and adherence among PWID to inform the initial adaptation of existing theory-based interventions; Conduct qualitative interviews with  30 PWID and  10 key informants (PrEP and other clinical and social service providers) to identify intervention targets; Develop and iteratively refine and finalize an intervention manual based on feedback from qualitative exit-interviews with an interventionist and  10 PWID; and Conduct a pilot randomized clinical trial (RCT) in  50 HIV-uninfected PWID to compare PrEP uptake and adherence outcomes and assess intervention feasibility and acceptability.

Detailed Description
-----------------
This mixed methods phased research will use qualitative and quantitative techniques to improve PrEP uptake and adherence among PWID through the following three phases: Phase 1 will identify the modifiable determinants of PrEP uptake and adherence among HIV-uninfected PWID using in-depth qualitative interviews with PWID and key informants (KIs). Qualitative interviews will explore perceived acceptability and identify barriers and facilitators to PrEP uptake and adherence among  30 HIV-uninfected PWID and explore perspectives on optimal PrEP delivery methods with  15 KIs (e.g., PrEP physicians, community-based organization staff members with experience working with PWID). Phase 2 will involve identifying intervention targets and adapting existing intervention strategies to improve PrEP uptake and adherence among PWID. This will involve reviewing the literature to identify and select components of existing, evidence-based medication adherence interventions to adapt for the unique determinants of PrEP uptake and adherence among PWID. Investigators will then develop and iteratively refine and finalize an intervention manual by conducting an open-pilot of the intervention in a community-based setting. Refinements will be based on feedback from qualitative exit-interviews with the interventionist and  10 PWID. Phase 3 will involve pilot testing the resulting PrEP uptake and adherence intervention in a selected community-based setting to obtain preliminary data on PrEP uptake and adherence outcomes (primary outcomes) and intervention feasibility and acceptability (secondary outcomes). Investigators will use a pilot RCT design with a mixed methods process evaluation in which 50 HIV-uninfected PWID will be randomized to the PrEP intervention or a control condition (SEP standard of care; n=25 per arm). Investigators will assess changes in PrEP outcomes (primary outcomes of uptake and adherence) and key implementation measures (e.g., secondary outcomes of acceptability, feasibility, adoption by the interventionist).

Official Title
-----------------
Optimizing Bio-behavioral HIV Prevention Approaches for People Who Inject Drugs

Conditions
-----------------
Intravenous Drug Abuse

Intervention / Treatment
-----------------
* Behavioral: PrEP uptake/adherence intervention
* Behavioral: Harm reduction standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
For all phases: Inclusion Criteria: An adult PWID Self report of any high risk behaviors for HIV (past-month receptive syringe sharing, transactional sex, condomless sex with an HIV-infected or unknown status partner) Exclusion Criteria: Unable or unwilling to provide informed consent For Phase 3 (the RCT pilot): Inclusion Criteria: Clinically eligible for PrEP (confirmed HIV-uninfected status, adequate renal function [estimated creatinine clearance ≥60 ml/min], and documented hepatitis B virus [HBV] status)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP uptake/adherence intervention<br>A trained interventionist will deliver the manualized, single session PrEP uptake/adherence intervention in private counseling rooms at a community-based setting. | Behavioral: PrEP uptake/adherence intervention<br>* The interventionist will follow the manual to deliver informational and motivational strategies to participants to enhance their PrEP uptake (including completing clinical screening and obtaining/filling a PrEP prescription) and adherence (taking daily oral PrEP doses). The interventionist will assist participants in problem-solving around topics including limited transportation options, identifying local pharmacies, storing medications given complex living arrangements, coping with side effects, communicating with providers and pharmacists, and maintaining daily medication schedules with reminders and cues.<br>|
| Active Comparator: Harm reduction standard of care<br>Participants will be provided harm reduction supplies and health information and counseling according to routine practice at the community-based setting. | Behavioral: Harm reduction standard of care<br>* Participants will be provided with harm reduction supplies and health information and counseling according to routine practice at the community-based setting (harm reduction organization).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP uptake by self-report | measured using 1 item in a structured questionnaire | 1 month | 
| PrEP uptake by self-report | measured using 1 item in a structured questionnaire | 3 months | 
| PrEP uptake by pharmacy records | measured by accessing pharmacy records | 1 month | 
| PrEP uptake by pharmacy records | measured by accessing pharmacy records | 3 months | 
| PrEP adherence by self-report | measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed | 1 month | 
| PrEP adherence by self-report | measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed | 3 months | 
| PrEP adherence by dried blood spot | measured via detection of tenofovir and emtricitabine in dried blood spots (DBS) | 1 month | 
| PrEP adherence by dried blood spot | measured via detection of tenofovir and emtricitabine in dried blood spots (DBS) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction with intervention content | assessed via qualitative exit interviews exploring satisfaction with the intervention content (including an open-ended question on topics that were helpful and unhelpful) | 1 month | 
| Participant satisfaction with intervention delivery methods | assessed via qualitative exit interviews exploring satisfaction with the intervention delivery methods (including an open-ended question on how helpful or unhelpful the intervention delivery methods were) | 1 month | 
| Interventionist satisfaction with training materials | assessed via qualitative exit interviews exploring satisfaction with the training materials for interventionists (including an open-ended question on how helpful or unhelpful the training materials were) | 1 month | 
| Interventionist satisfaction with intervention manual | assessed via qualitative exit interviews exploring satisfaction with the intervention manual (including an open-ended question on how helpful or unhelpful the intervention manual was) | 1 month | 
| Interventionist satisfaction with intervention content | assessed via qualitative exit interviews exploring satisfaction with the intervention content (including an open-ended question on topics that were helpful and unhelpful) | 1 month | 
| Interventionist satisfaction with intervention delivery methods | assessed via qualitative exit interviews exploring satisfaction with the training materials, intervention manual, intervention content, intervention delivery methods (including an open-ended question on how helpful or unhelpful the intervention delivery methods were) | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiretroviral pre-exposure prophylaxis (PrEP), Syringe exchange program (SEP), HIV-related risk behaviors, Adherence intervention, People who inject drugs (PWID)