Clinical trial NCT02183909: Connecting Resources for Urban Sexual Health
Official title: Connecting Resources for Urban Sexual Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Infections
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 378
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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

Eligibility 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®

Primary outcomes:
measure: The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
timeFrame: 1 year
measure: The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 4 Weeks
Secondary outcomes:
measure: Substudy Secondary Outcome: The Renal Safety of Stribild® PEP
timeFrame: 1 Week and 4 Weeks
measure: Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR
timeFrame: 1 Week and 4 Weeks
measure: Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP
timeFrame: 4 Weeks
measure: Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP
timeFrame: 4 Weeks
measure: Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
timeFrame: 4 Weeks
measure: Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
timeFrame: 4 Weeks
measure: Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
timeFrame: 4 Weeks
measure: Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Downtown Youth Clinic
state: California
Study officials:
affiliation: East Bay AIDS Center (EBAC)
name: Jeff Burack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gladstone Institutes
name: Robert Grant, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Center for AIDS Prevention
name: Janet Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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