HIV, Sexually Transmitted Infections
Conditions
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
Interventions
OTHERTesting 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.
BEHAVIORALEngagement 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.
OTHEREngagement 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.
DRUGStribild 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).
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment | 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. |
| The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care | 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. |
| 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 | 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. |
| 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 | 4 Weeks | Regimen completion at 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substudy Secondary Outcome: The Renal Safety of Stribild® PEP | 1 Week and 4 Weeks | Change from week 1 to week 4 in serum creatinine. |
| Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | 4 Weeks | Self-reported adherence. |
| Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR | 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. |
| Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP | 4 Weeks | Markers of proximal tubulopathy (glycosuria, proteinuria \> 1+). |
| Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP | 4 Weeks | HIV-1 seroconversion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV Negative YMSM Testing and linkage to care for YMSM: Implementation of strategies to enhance testing and linkage to care of YMSM, including social network testing and a youth outreach corps working with existing and new community partner agencies. Engagement and retention for HIV-negative YMSM 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. Stribild PEP Substudy: 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP). | 257 |
| Total | 257 |
Baseline characteristics
| Characteristic | HIV Negative YMSM |
|---|---|
| Age, Continuous | 24.2 years STANDARD_DEVIATION 2.86 |
| Exposure to gun violence (ever) | 38 Participants |
| Health insurance in the past Multiple Types reported | 27 Participants |
| Health insurance in the past None | 13 Participants |
| Health insurance in the past Other Coverage | 69 Participants |
| Health insurance in the past Private Insurance | 110 Participants |
| Health insurance in the past Public Insurance | 38 Participants |
| Highest level of education High school or less | 65 Participants |
| Highest level of education Missing | 4 Participants |
| Highest level of education Some education post-high school | 188 Participants |
| Household is receiving public assistance No | 222 Participants |
| Household is receiving public assistance No Response/missing | 6 Participants |
| Household is receiving public assistance Yes | 29 Participants |
| Mental health (BSI screen symptomatic) Missing data | 1 Participants |
| Mental health (BSI screen symptomatic) No | 254 Participants |
| Mental health (BSI screen symptomatic) Yes | 2 Participants |
| No. of sex partners Mean in past 3 mo | 7.65 Sex partners STANDARD_DEVIATION 8.1 |
| No. of survival-related needs | 0.55 Number of competing needs reported STANDARD_DEVIATION 0.98 |
| Race/Ethnicity, Customized African American | 40 Participants |
| Race/Ethnicity, Customized Asian | 33 Participants |
| Race/Ethnicity, Customized Latino | 84 Participants |
| Race/Ethnicity, Customized Mixed | 17 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Refused/no response | 17 Participants |
| Race/Ethnicity, Customized White | 64 Participants |
| Received PEP at baseline visit No | 227 Participants |
| Received PEP at baseline visit Yes | 30 Participants |
| Region of Enrollment United States | 257 Participants |
| Self-reported sexual orientation Bisexual | 217 Participants |
| Self-reported sexual orientation Gay | 29 Participants |
| Self-reported sexual orientation Other | 7 Participants |
| Self-reported sexual orientation Refused to answer | 1 Participants |
| Self-reported sexual orientation Straight | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 257 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 378 |
| other Total, other adverse events | 0 / 378 |
| serious Total, serious adverse events | 0 / 378 |
Outcome results
Primary
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
Regimen completion at 28 days.
Time frame: 4 Weeks
Population: 100 participants enrolled in the Stribild® sub study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Intervention | 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 | 69 Participants |
Primary
The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care
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.
Time frame: 1 year
Population: HIV positive individuals in the CRUSH study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Intervention | The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care | Retained at 1 year | 81 Participants |
| Study Intervention | The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care | On Therapy at 1 year | 52 Participants |
| Study Intervention | The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care | Viral suppression | 47 Participants |
Primary
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
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.
Time frame: 1 year
Population: All HIV negative YMSM who enrolled in the CRUSH study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Intervention | 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 | Retained | Yes | 243 Participants |
| Study Intervention | 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 | Retained | No | 14 Participants |
| Study Intervention | 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 | Received STI testing | Yes | 188 Participants |
| Study Intervention | 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 | Received STI testing | No | 69 Participants |
| Study Intervention | 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 | Received PrEP | Yes | 239 Participants |
| Study Intervention | 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 | Received PrEP | No | 18 Participants |
| Study Intervention | 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 | Received PEP | Yes | 30 Participants |
| Study Intervention | 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 | Received PEP | No | 227 Participants |
Primary
The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
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.
Time frame: 1 year
Population: The analysis population is all individuals who completed an enrollment process.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Intervention | The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment | Previously in care | 70 Participants |
| Study Intervention | The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment | Newly in care at CRUSH | 28 Participants |
| Study Intervention | The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment | HIV negative | 280 Participants |
Secondary
Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR
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.
Time frame: 1 Week and 4 Weeks
Population: The number of participants with data available for this measure at four weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Intervention | Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR | -1.4286 mL/min/1.73m2 | Standard Deviation 10.86424 |
Secondary
Substudy Secondary Outcome: The Renal Safety of Stribild® PEP
Change from week 1 to week 4 in serum creatinine.
Time frame: 1 Week and 4 Weeks
Population: The number of participants with data available for this measure at four weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Intervention | Substudy Secondary Outcome: The Renal Safety of Stribild® PEP | .0380 mg/dl | Standard Deviation 0.10855 |
Secondary
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Early cessation of regimen.
Time frame: 4 Weeks
Population: 100 participants enrolled in the Stribild® sub study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | 11 Participants |
Secondary
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Changes from baseline in quality of life.
Time frame: 4 Weeks
Population: Data were not collected for the quality of life measure.
Secondary
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Reported reasons for non-adherence
Time frame: 4 Weeks
Population: 69 substudy participants provided responses regarding reasons for adherence.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Reasons for any non-adherence | 69 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Didn't have pills with me | 36 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Forgot to take my pills | 53 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Didn't feel like taking it | 2 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Schedule changes | 42 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Wanted to take it privately | 9 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Side-effects or feeling ill | 13 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Planned to drink/get high | 7 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | I was drunk/high | 4 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Felt too emotional (sad, angry, anxious) | 7 Participants |
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | Was saving them for later | 1 Participants |
Secondary
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Self-reported adherence.
Time frame: 4 Weeks
Population: 100 participants enrolled in the Stribild® sub study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Intervention | Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP | 69 Participants |
Secondary
Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP
Markers of proximal tubulopathy (glycosuria, proteinuria \> 1+).
Time frame: 4 Weeks
Population: 100 participants enrolled in the Stribild® sub study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Intervention | Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP | 0 Participants |
Secondary
Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP
HIV-1 seroconversion.
Time frame: 4 Weeks
Population: 23 participants did not return for the week 4 visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Intervention | Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP | 0 Participants |