Efficacy of a community-based PrEP uptake intervention for people who inject drugs in the US Northeast

PROJECT SUMMARY/ABSTRACT
Background: A persistent ~10% of new U.S. HIV infections occur among people who inject drugs (PWID).
Provision of sterile syringes (via syringe service programs [SSPs] and pharmacies) helps prevent injection-
related HIV transmission; however, syringe access is insufficient in many locations, and the majority of PWID
experience substantial overlapping sexual and injection-related HIV risks. As in several geographic regions of
the United States, in the Northeast, increasing injection of opioids, stimulants, and other drugs is causing
renewed concerns about HIV transmission, with CDC declaring HIV outbreaks connected to injection drug use.
Despite the proven efficacy of pre-exposure prophylaxis (PrEP) and U.S. Preventive Services Task Force
recommendation that PrEP be offered to PWID at risk for HIV acquisition, uptake in this socially marginalized
population remains severely limited. Overview of Proposal: The current proposal is a culmination of extensive
preliminary research, including (a) in-depth qualitative research with PWID across Northeastern communities
affected by opioid use and HIV that documented high HIV risk and low PrEP knowledge but high interest, (b)
key informant interviews with PrEP providers, SSP staff, and other key stakeholders who provided specific
suggestions for PrEP intervention content and delivery strategies, and (c) two pilot randomized controlled trials
(RCTs) of PrEP Navigator-delivered behavioral interventions with high risk populations including people who
use drugs and PWID that demonstrated the feasibility, acceptability, and preliminary efficacy of our proposed
approach. This extensive research has led to the development of the “PrEP for Health” intervention.
Conceptual Model: “PrEP for Health” is a brief, multi-component behavioral intervention delivered to PWID by
highly trained PrEP Navigators embedded within SSPs that seeks to improve PrEP uptake (primary outcome)
and PrEP adherence and persistence (secondary outcomes) among PWID by increasing HIV and PrEP
knowledge, improving HIV risk perceptions and PrEP interest and motivation, cultivating PrEP use self-efficacy
and behavioral skills, and reducing structural barriers to PrEP use. Overview of Study Design: We propose
testing efficacy of “PrEP for Health” in two SSPs in Lawrence and Boston/Cambridge, Massachusetts, areas
heavily affected by injection-related HIV transmission. We will equally randomize 200 PWID to receive either
(a) the “PrEP for Health” intervention, which includes Navigator-delivered, theory-informed HIV and PrEP
education, motivational interviewing, problem-solving and planning, and ongoing PrEP navigation (n=100), or
(b) standard of care (information and referrals; n=100). We will evaluate successful PrEP uptake (via
medical/pharmacy records), adherence (via drug levels in hair), and persistence (via medical/ pharmacy
records) over 12 months. We will also examine the degree to which intervention efficacy occurs through
specific conceptual mediators (e.g., PrEP knowledge, motivation, self-efficacy) and differs according to
hypothesized moderators (e.g., age, gender, sexual risk).

Grant Number: 5R01DA051849-05
NIH Institute/Center: NIH
Principal Investigator: Katie Biello