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

March 8, 2021 updated by: Boston University

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

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.

Study Overview

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).

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PrEP uptake/adherence intervention
A trained interventionist will deliver the manualized, single session PrEP uptake/adherence intervention in private counseling rooms at a community-based setting.
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.
Active Comparator: Harm reduction standard of care
Participants will be provided harm reduction supplies and health information and counseling according to routine practice at the community-based setting.
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Angela Bazzi, PhD, MPH, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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