Connecting Resources for Urban Sexual Health (CRUSH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 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: January 23, 2015
Last verified: January 2015
  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).

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.


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
Drug: Stribild PEP Substudy

Study Type: Interventional
Study Design: 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.

  • Substudy Primary Outcome: To 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Regimen completion at 28 days.


Secondary Outcome Measures:
  • Substudy Secondary Outcome: To assess the renal safety of Stribild® PEP. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Change from baseline in serum creatinine and eGFR.

  • Substudy Secondary Outcome: To assess the renal safety of Stribild® PEP. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Markers of proximal tubulopathy (glycosuria, proteinuria > 1+).

  • Substudy Secondary Outcome: To document any HIV-1 seroconversions occurring while on Stribild® PEP. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    HIV-1 seroconversion.

  • Substudy Secondary Outcome: To document the side effect profile of Stribild® given as PEP [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Frequency of adverse events.

  • Substudy Secondary Outcome: To assess adherence to Stribild® PEP. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Self-reported adherence and reasons for non-adherence.

  • Substudy Secondary Outcome: To assess adherence to Stribild® PEP. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Changes from baseline in quality of life.

  • Substudy Secondary Outcome: To assess adherence to Stribild® PEP. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Early cessation of regimen.


Estimated Enrollment: 670
Study Start Date: May 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study intervention 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.
Drug: Stribild PEP Substudy
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).

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

  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.

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®
  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: January 23, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2015