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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04240509
• Other study ID #: PrEP Care-Gilead
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection
• Sexually Transmitted Diseases

Intervention

Drug:
• Emtricitabine / Tenofovir
Incarcerated men identified at high risk for HIV transmission will be given a 30-day supply of the study drug and will be provided with patient navigation to follow up care upon release.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number retained in PrEP care	The primary outcome of the proposed study will be the number of individuals retained in PrEP care at 6 months	6 months