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临床试验/NCT04240509
NCT04240509Unknown4 期

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

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Number retained in PrEP care

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

结局指标

主要结局

Number retained in PrEP care

时间窗: 6 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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