Connecting Resources for Urban Sexual Health
Condition: HIV; Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. 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.

        2. 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
    

Intervention name(s): Testing and linkage to care for Y/MSM; Engagement and retention for HIV-positive Y/MSM in care; Engagement and retention for HIV-negative Y/MSM in sexual health services; Stribild PEP Substudy
Intervention type(s): Other; Behavioral; Other; Drug
Intervention description(s): Implementation of strategies to enhance testing and linkage to care of Y/MSM, including social network testing and a youth outreach corps working with existing and new community partner agencies.; Optimizing current HIV care and treatment services at DYC by implementing a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.; Offering a highly effective combination HIV prevention strategy, including PrEP; warm-hand offs for high-risk negatives, nPEP; risk reduction counseling; frequent HIV and STI testing, including testing a highly sensitive method of detecting early HIV infection; and youth-focused programming.; A substudy of 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP).
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other