Packaging PrEP to Prevent HIV Among WWID

Pre-exposure prophylaxis (PrEP) is a promising bio-medical HIV prevention strategy that
involves the use of single daily dose of emtricitabine/tenofovir disoproxil fumarate
(FTC/TDF) by HIV-negative individuals to reduce risk of acquiring HIV. Evidence suggests
women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence
continues unchecked, 1 in 23 WWID in the United States will acquire HIV. One concern
regarding PrEP implementation for WWID is that they will face a number of challenges to
engaging in PrEP care. To reduce barriers and thereby increase the individual and public
health benefits of PrEP, alternative approaches based outside of traditional clinical
settings are needed. The proposed research is significant, because PrEP could reduce HIV
acquisition among WWID. However, at present, there is little knowledge to help address PrEP
implementation challenges for this understudied group. The proposed research is highly
innovative, because it will address this knowledge gap by evaluating a novel approach for the
delivery of PrEP care: pairing PrEP with community-based syringe exchange program (SEP)
services. This approach may represent a paradigm shift that enables and encourages women in
this highly vulnerable population to engage in effective biomedical HIV prevention
strategies. The rationale is that (1) SEPs may currently provide prescription medications and
long-term monitoring for other conditions such as buprenorphine for opioid dependence, so
providing PrEP care is a natural extension of what is already being done successfully; (2)
SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible
for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings
already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP.
To evaluate this approach, a prospective mixed methods study will be initiated within the
largest SEP in the mid-Atlantic region. Through semi-structured and in-depth interviews based
on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for FTC/TDF
adherence, the following specific aims will be addressed: (1) Describe WWID's engagement in
the PrEP care continuum (focusing on critical moments when women could disengage or need
additional support to remain in care). (2) Identify factors from the BVMP that are associated
with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are
associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP
and SEP services has yet to be tested. This is exploratory study will provide preliminary
data to generate hypotheses for future intervention studies. The long-term outcome of this
research program will be a reduction in HIV among WWID through the delivery of HIV prevention
interventions that include PrEP. The reproducibility of this approach, resulting from
utilization of an already functional service delivery system, significantly increases the
potential for translation to other settings and PWID populations, including men who inject
drugs, in domestic and global contexts.