Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection
Status:
Enrolling by invitation
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Background: Several major studies have demonstrated the success of Truvada as pre-exposure
prophylaxis (PrEP) in preventing HIV infection.The CDC guidelines recommend PrEP for people
who are at elevated risk of HIV including men who have sex with men (MSM) and people who use
injection drugs. People who are incarcerated bear a disproportionate of disease burden,
including HIV. Furthermore, men who have been involved with the criminal justice system are
more likely to engage in risky behaviors following their release, including condomless sex
with partners of unknown serostatus, and injection drug use.
The incarceration setting provides a place to engage men who may be at risk of HIV after they
are released.
Following release, community clinics, including the STD clinic at The Miriam Hospital (TMH)
Immunology Center, that perform routine testing for HIV and other sexually transmitted
diseases (STDs) may be ideal settings to engage vulnerable populations in care, including
PrEP.
Despite the demonstrated clinical efficacy of PrEP in reducing HIV transmissions, few
clinical programs have piloted the use of PrEP in real-world settings, particularly criminal
justice settings. Furthermore, studies demonstrate numerous challenges to PrEP uptake and
adherence, including a lack of access or discontinuing care. Engaging at risk men in PrEP
care before they leave prison and potentially lost to care during the transition may increase
uptake, adherence, and retention.
Objective: This study protocol will evaluate a clinical program that aims to prevent new HIV
infections among recently-incarcerated men using a once daily dosing of
tenofovir/emtricitabine (Truvada) as pre-exposure prophylaxis (PrEP). This protocol presents
an overview of the clinical program, which uses standard-of-care clinical practices and
Centers for Disease Control and Prevention (CDC) guidelines for prescribing and monitoring
PrEP.
Male inmates at the Rhode Island Department of Corrections (RIDOC) will be screened for HIV
risk and, if eligible and interested, will be prescribed and given a one-month supply of PrEP
shortly before their release, and receive follow up care at The Miriam Hospital (TMH)
Immunology Center following their release.