Trial Outcomes & Findings for Connecting Resources for Urban Sexual Health (NCT NCT02183909)
NCT ID: NCT02183909
Last Updated: 2024-12-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
378 participants
Primary outcome timeframe
1 year
Results posted on
2024-12-12
Participant Flow
Participant milestones
| Measure |
Study Intervention
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-positive YMSM 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. 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).
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|---|---|
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Overall Study
STARTED
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378
|
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Overall Study
COMPLETED
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324
|
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Overall Study
NOT COMPLETED
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54
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Connecting Resources for Urban Sexual Health
Baseline characteristics by cohort
| Measure |
HIV Negative YMSM
n=257 Participants
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).
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|---|---|
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Received PEP at baseline visit
Yes
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30 Participants
n=5 Participants
|
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Mental health (BSI screen symptomatic)
No
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254 Participants
n=5 Participants
|
|
Mental health (BSI screen symptomatic)
Yes
|
2 Participants
n=5 Participants
|
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Mental health (BSI screen symptomatic)
Missing data
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1 Participants
n=5 Participants
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No. of sex partners Mean in past 3 mo
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7.65 Sex partners
STANDARD_DEVIATION 8.1 • n=5 Participants
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No. of survival-related needs
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0.55 Number of competing needs reported
STANDARD_DEVIATION 0.98 • n=5 Participants
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Exposure to gun violence (ever)
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38 Participants
n=5 Participants
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Age, Continuous
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24.2 years
STANDARD_DEVIATION 2.86 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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257 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
African American
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40 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Latino
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84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
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64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
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33 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Other
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2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
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17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Refused/no response
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17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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257 Participants
n=5 Participants
|
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Self-reported sexual orientation
Straight
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3 Participants
n=5 Participants
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Self-reported sexual orientation
Gay
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29 Participants
n=5 Participants
|
|
Self-reported sexual orientation
Bisexual
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217 Participants
n=5 Participants
|
|
Self-reported sexual orientation
Other
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7 Participants
n=5 Participants
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|
Self-reported sexual orientation
Refused to answer
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1 Participants
n=5 Participants
|
|
Highest level of education
High school or less
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65 Participants
n=5 Participants
|
|
Highest level of education
Some education post-high school
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188 Participants
n=5 Participants
|
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Highest level of education
Missing
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4 Participants
n=5 Participants
|
|
Household is receiving public assistance
No Response/missing
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6 Participants
n=5 Participants
|
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Household is receiving public assistance
No
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222 Participants
n=5 Participants
|
|
Household is receiving public assistance
Yes
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29 Participants
n=5 Participants
|
|
Health insurance in the past
None
|
13 Participants
n=5 Participants
|
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Health insurance in the past
Public Insurance
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38 Participants
n=5 Participants
|
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Health insurance in the past
Private Insurance
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110 Participants
n=5 Participants
|
|
Health insurance in the past
Other Coverage
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69 Participants
n=5 Participants
|
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Health insurance in the past
Multiple Types reported
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27 Participants
n=5 Participants
|
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Received PEP at baseline visit
No
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227 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 yearPopulation: The analysis population is all individuals who completed an enrollment process.
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.
Outcome measures
| Measure |
Study Intervention
n=378 Participants
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. 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.
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.
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-ex
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|---|---|
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The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
Previously in care
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70 Participants
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The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
Newly in care at CRUSH
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28 Participants
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The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
HIV negative
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280 Participants
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PRIMARY outcome
Timeframe: 1 yearPopulation: HIV positive individuals in the CRUSH study.
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.
Outcome measures
| Measure |
Study Intervention
n=98 Participants
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. 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.
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.
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-ex
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|---|---|
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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
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81 Participants
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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
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52 Participants
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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
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47 Participants
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PRIMARY outcome
Timeframe: 1 yearPopulation: All HIV negative YMSM who enrolled in the CRUSH study.
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.
Outcome measures
| Measure |
Study Intervention
n=257 Participants
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. 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.
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.
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-ex
|
|---|---|
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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
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243 Participants
|
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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
|
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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
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188 Participants
|
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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
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69 Participants
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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
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239 Participants
|
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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
|
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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
|
|
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
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227 Participants
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PRIMARY outcome
Timeframe: 4 WeeksPopulation: 100 participants enrolled in the Stribild® sub study.
Regimen completion at 28 days.
Outcome measures
| Measure |
Study Intervention
n=100 Participants
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. 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.
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.
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-ex
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|---|---|
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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
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69 Participants
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SECONDARY outcome
Timeframe: 1 Week and 4 WeeksPopulation: The number of participants with data available for this measure at four weeks.
Change from week 1 to week 4 in serum creatinine.
Outcome measures
| Measure |
Study Intervention
n=30 Participants
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. 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.
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.
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-ex
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|---|---|
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Substudy Secondary Outcome: The Renal Safety of Stribild® PEP
|
.0380 mg/dl
Standard Deviation .10855
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SECONDARY outcome
Timeframe: 1 Week and 4 WeeksPopulation: The number of participants with data available for this measure at four 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.
Outcome measures
| Measure |
Study Intervention
n=28 Participants
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. 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.
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.
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-ex
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|---|---|
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Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR
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-1.4286 mL/min/1.73m2
Standard Deviation 10.86424
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SECONDARY outcome
Timeframe: 4 WeeksPopulation: 100 participants enrolled in the Stribild® sub study.
Markers of proximal tubulopathy (glycosuria, proteinuria \> 1+).
Outcome measures
| Measure |
Study Intervention
n=100 Participants
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. 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.
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.
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-ex
|
|---|---|
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Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP
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0 Participants
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SECONDARY outcome
Timeframe: 4 WeeksPopulation: 23 participants did not return for the week 4 visit.
HIV-1 seroconversion.
Outcome measures
| Measure |
Study Intervention
n=77 Participants
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. 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.
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.
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-ex
|
|---|---|
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Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: 100 participants enrolled in the Stribild® sub study.
Self-reported adherence.
Outcome measures
| Measure |
Study Intervention
n=100 Participants
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. 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.
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.
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-ex
|
|---|---|
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Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
|
69 Participants
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SECONDARY outcome
Timeframe: 4 WeeksPopulation: 69 substudy participants provided responses regarding reasons for adherence.
Reported reasons for non-adherence
Outcome measures
| Measure |
Study Intervention
n=69 Participants
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. 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.
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.
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-ex
|
|---|---|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Reasons for any non-adherence
|
69 Participants
|
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Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Didn't have pills with me
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36 Participants
|
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Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Forgot to take my pills
|
53 Participants
|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Didn't feel like taking it
|
2 Participants
|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Schedule changes
|
42 Participants
|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Wanted to take it privately
|
9 Participants
|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Planned to drink/get high
|
7 Participants
|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
I was drunk/high
|
4 Participants
|
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Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Felt too emotional (sad, angry, anxious)
|
7 Participants
|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Was saving them for later
|
1 Participants
|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Side-effects or feeling ill
|
13 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Data were not collected for the quality of life measure.
Changes from baseline in quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 WeeksPopulation: 100 participants enrolled in the Stribild® sub study.
Early cessation of regimen.
Outcome measures
| Measure |
Study Intervention
n=100 Participants
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. 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.
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.
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-ex
|
|---|---|
|
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
|
11 Participants
|
Adverse Events
Study Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janet Myers, PhD, MPH, MA
University of California, San Francisco
Phone: 415-502-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place