Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection

Sponsor

The Miriam Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04240509

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Sexually Transmitted Diseases	Drug: Emtricitabine / Tenofovir	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Number retained in PrEP care [6 months]
The primary outcome of the proposed study will be the number of individuals retained in PrEP care at 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Current men committed at the RIDOC (aged 18 and above); HIV negative; meet CDC indications for PrEP use (based on risk criteria before they were sentenced); interested in taking PrEP; and are able to voluntarily consent to be treated will be included

Exclusion Criteria:

Individuals who are younger than 18 years old; are HIV positive, Hepatitis B Virus positive or have a CrCl<60; or unable to provide voluntary consent will be excluded.