Clinical Trials

MainTitle

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

This study has been enrolling by invitation
Sponsor
The Miriam Hospital


Information provided by (Responsible Party)
The Miriam Hospital
ClinicalTrials.gov Identifier
NCT04240509

First received: January 16, 2020
Last updated: January 21, 2020
Last Verified: January 2020
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections
Sexually Transmitted Diseases

Drug : Emtricitabine / Tenofovir
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures

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

Estimated Enrollment: 100
Study Start Date: November 1, 2019
Estimated Study Completion Date: February 27, 2021
Estimated Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04240509

Locations

United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

The Miriam Hospital
More Information

More Information


Responsible Party: The Miriam Hospital  
ClinicalTrials.gov Identifier: NCT04240509   History of Changes  
Other Study ID Numbers: PrEP Care-Gilead  
Study First Received: January 16, 2020  
Last Updated: January 21, 2020  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Additional relevant MeSH terms:
Infection
Communicable Diseases
Sexually Transmitted Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Tenofovir
Emtricitabine

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.