Connecting Resources for Urban Sexual Health (CRUSH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02183909
First received: May 6, 2014
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
HIV
Sexually Transmitted Infections
Other: Testing and linkage to care for Y/MSM
Behavioral: Engagement and retention for HIV-positive Y/MSM in care
Other: Engagement and retention for HIV-negative Y/MSM in sexual health services

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Connecting Resources for Urban Sexual Health

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • The proportion of young men who have sex with men (YMSM) of color who test positive for HIV at partner agencies and the proportion of positive and negative YMSM who are tested for HIV and linked to care on a quarterly and annual basis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 670
Study Start Date: May 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Testing and linkage to care for Y/MSM
    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.
    Behavioral: Engagement and retention for HIV-positive Y/MSM in care
    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.
    Other: Engagement and retention for HIV-negative Y/MSM in sexual health services
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None.
  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: NCT02183909

Contacts
Contact: Jeff Burack, MD (510) 869-8400 BurackJ@sutterhealth.org
Contact: Ife Udoh, PhD (510) 869-8400 iudoh@pgaf.org

Locations
United States, California
Downtown Youth Clinic Recruiting
Oakland, California, United States, 94609
Contact: Ife Udoh, PhD    510-869-8400    iudoh@pgaf.org   
Contact: Michael D'Arata, FNP, B.Ed    510-869-8486    DarataM@sutterhealth.org   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jeff Burack, MD East Bay AIDS Center (EBAC)
Principal Investigator: Robert Grant, MD, MPH Gladstone Institutes
Principal Investigator: Janet Myers, PhD UCSF Center for AIDS Prevention
  More Information

Additional Information:
Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02183909     History of Changes
Other Study ID Numbers: EI12-EBACA-003
Study First Received: May 6, 2014
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 11, 2014