Connecting Resources for Urban Sexual Health
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 29 |
| Updated: | 11/23/2017 |
| Start Date: | May 2013 |
| End Date: | August 2017 |
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.
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.
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
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
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:
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®
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