Connecting Resources for Urban Sexual Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
研究概览
简要总结
The overall goal of the CRUSH project is to enhance and extend a response to the local HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions across the continuum of HIV prevention and care, targeting individuals and communities most vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key community-based organizations, are engaging in a participatory partnership to enhance and implement HIV services which target the East Bay's highest risk population- young men who have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a combination of program approaches to address the sexual health care needs of young gay men of color and their sexual partners by enhancing the current program activities of the Downtown Youth Clinic (DYC).
We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC services structure in two ways. We intend to expand HIV testing, and linkage to and retention in care for youth who test HIV positive, providing them with intensive risk-reduction counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further HIV transmission. And we intend for the first time to offer a comprehensive combination package of preventive services to HIV-negative youth, including routine accesses to HIV/STI screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).
The CRUSH Project will also have a substudy that will enroll HIV-negative participants who are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual acquisition of HIV-1 in Y/MSM of color.
详细描述
The CRUSH Project (Connecting Resources for Urban Sexual Health) is a demonstration project at Alta Bates Summit Medical Center's East Bay AIDS Center (EBAC) and Downtown Youth Clinic (DYC) offering interventions aimed at reducing HIV-1 incidence among young MSM of color in the East Bay region. CRUSH has two major components:
- Providing enhanced testing and linkage to care (TLC+) for HIV positives, aimed at increasing the proportion of HIV positive Y/MSM who are in care, virologically suppressed, and receiving intensive risk reduction counseling.
- Providing comprehensive sexual health services to high risk HIV-negatives, including but not limited to the provision of PrEP and PEP when clinically appropriate.
In addition, the CRUSH Project will offer a substudy of CRUSH, and will enroll HIV negative CRUSH participants who are eligible to receive PEP. Stribild® is a single-tablet, four-drug, once-daily complete regimen that is FDA-approved for the treatment of HIV-1 infection in treatment-naïve HIV-infected adults with estimated glomerular filtration rate ≥70ml/min/1.73m2. Because of limited data, no antiretroviral drug or combination of drugs has been approved for PEP. Current PEP guidelines generally call for using a 28-day course of a 3-drug regimen that has been approved for the treatment of HIV-1 infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men between the ages of 18-29 who are ever sexually active with men;
- •Transgender females (M2F) between the ages of 18-29 who are sexually active with men; Transgender males (F2M) between the ages of 18-29 who are sexually active with men; and
- •Any HIV-negative person aged 18-29, male or female, who has at least one known HIV positive (i.e. serodiscordant) sexual partner.
排除标准
- •For the PEP substudy the inclusion criterion is at least one episode in the 72 hours prior to presentation of unprotected receptive anal intercourse with a partner known or suspected to be HIV positive and the following are the substudy exclusion criteria:
- •Known kidney disease
- •Dipstick proteinuria >1+
- •eGFR < 70 ml/min/1.73m2
- •Known metabolic bone disease
- •Signs or symptoms of acute HIV infection
- •Concomitant use of nephrotoxic drug or medication contraindicated with Stribild®
研究组 & 干预措施
Study intervention
干预措施: Testing and linkage to care for Y/MSM (Other)
Study intervention
干预措施: Engagement and retention for HIV-positive Y/MSM in care (Behavioral)
Study intervention
干预措施: Engagement and retention for HIV-negative Y/MSM in sexual health services (Other)
Study intervention
干预措施: Stribild PEP Substudy (Drug)
结局指标
主要结局
The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
时间窗: 1 year
Expanding the investigators currently successful HIV testing strategy-collaborations and systems of referral of new cases of HIV from existing partners-so that referrals are also received for high risk negatives to receive sexual health services. Implementing two new strategies: social network testing and a youth outreach corps working with partner agencies; it is hypothesized that social network testing will increase the proportion of positive test results.
The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care
时间窗: 1 year
Optimizing current HIV care and treatment services at DYC by adding three new components: a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.
The Proportion of HIV-uninfected YMSM Participants Who Are Retained, Receive Sexually Transmitted Infection (STI) Testing, and Receive Non-occupational Post-exposure-prophylaxis (nPEP) and/or PrEP
时间窗: 1 year
Integrating sexual health services for HIV-uninfected young MSM of color into an HIV care setting, including PrEP, warm-hand offs for high risk negatives, nPEP, risk reduction counseling, frequent HIV and STI testing, and youth-focused programming.
Substudy Primary Outcome: The Tolerability and Acceptability of a 28 Day Course of Stribild® Given as Post-exposure Prophylaxis (PEP) to Prevent Sexual Acquisition of HIV-1
时间窗: 4 Weeks
Regimen completion at 28 days.
次要结局
- Substudy Secondary Outcome: The Renal Safety of Stribild® PEP(1 Week and 4 Weeks)
- Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR(1 Week and 4 Weeks)
- Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP(4 Weeks)
- Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP(4 Weeks)
- Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP(4 Weeks)