Connecting Resources for Urban Sexual Health (CRUSH)

November 15, 2024 updated by: University of California, San Francisco

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
378

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
        • Downtown Youth Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
Time Frame: 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.
1 year
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
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.
1 year
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
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.
1 year
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
Time Frame: 4 Weeks
Regimen completion at 28 days.
4 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Substudy Secondary Outcome: The Renal Safety of Stribild® PEP
Time Frame: 1 Week and 4 Weeks
Change from week 1 to week 4 in serum creatinine.
1 Week and 4 Weeks
Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR
Time Frame: 1 Week and 4 Weeks
To Assess the Renal Safety of Stribild® PEP. Change from 1 Week to 4 Weeks in estimated glomerular filtration rate (eGFR), which measures how well the kidneys are filtering waste and toxins from the blood.
1 Week and 4 Weeks
Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP
Time Frame: 4 Weeks
Markers of proximal tubulopathy (glycosuria, proteinuria > 1+).
4 Weeks
Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP
Time Frame: 4 Weeks
HIV-1 seroconversion.
4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time Frame: 4 Weeks
Self-reported adherence.
4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time Frame: 4 Weeks
Reported reasons for non-adherence
4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time Frame: 4 Weeks
Changes from baseline in quality of life.
4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time Frame: 4 Weeks
Early cessation of regimen.
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EI12-EBACA-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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