- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03194477
Providing Unique Support for Health (PUSH) Study
Identifying and Engaging Urban HIV Infected and Uninfected YBMSM in Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Project Summary The U.S. National HIV/AIDS Strategy 2020 calls for increasing access to care and improving outcomes of people living with HIV and targeting biomedical prevention efforts (including access to pre-exposure prophylaxis [PrEP]) where HIV is most heavily concentrated. Baltimore, MD; Washington, DC; Philadelphia, PA (BWP); and Tampa and St. Petersburg, FL. are disproportionately burdened by high rates of new cases of HIV infection, with disproportionate rates in young Black and/or Latinx men who have sex with men (YBLMSM) and transgender women (YBLTW) aged 15-24. High incidence underscores the need for increased identification, linkage and initiation in HIV and preventive care for YBLMSM. Grants focused on high rates directly address NIH research priorities to reduce health disparities in the incidence of HIV, in antiretroviral therapy (ART) outcomes or in high HIV prevalent or high-risk areas.
This innovative proposal seeks to test, treat and retain YBLMSM/TW living in BWP along the prevention and treatment continuum using the following aims:
Aim 1. Identify and recruit young (ages 15-24) Black and/or Latinx men who have sex with men (YBLMSM) in 3 urban cities who are (1) HIV-infected, not virally suppressed; and (2) high-risk HIV-uninfected YBLMSM, including gender variant and questioning men, using respondent driven sampling (RDS) with targeted seed identification. Assigned female sex at birth participants may be eligible to screen and participate in this aim to assist in recruiting YBLMSM/TW; Aim 2. Compare the efficacy of two study arms (mobile-enhanced engagement intervention (MEI) vs. standard of care (SOC)) to achieve sustained retention (measured by ≥ 4 follow up visits per 18-months) and engagement in HIV care (measured by durable viral suppression (HIV VL < 20 copies/ml) and substance treatment among 240 HIV-infected YBLMSM who are not virally suppressed and recruited from RDS; and Aim 3. Modify and implement mobile-enhanced intervention for 225 high-risk HIV-uninfected YBLMSM, recruited from RDS to promote linkage, retention and engagement of pre-exposure prophylaxis (PrEP) and substance treatment uptake over 18-months, comparing younger (15-19) and older (20-24) participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Center for Adolescent and Young Adult Health at Johns Hopkins Harriet Lane
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Natal Male Inclusion Criteria:
- Assigned male at birth
- 15-24 years old
- English speaking
- Black/African American
- Hispanic/Latino ethnicity
- HIV positive, viral load of 20 or greater
- HIV negative, at high risk of HIV acquisition
- Sex with another male within last 12-months
- No plans to move outside of the research catchment area in next 18-months
- Able and willing to provide informed consent
- Not currently taking pre-exposure prophylaxis (PrEP)
- Not currently enrolled or planning to enrolled in an HIV vaccine trial
- Not currently enrolled or planning to enroll in an HIV adherence intervention
Natal Male Exclusion Criteria:
- Birth-identified female
- under age 15
- Over age 24
- Non-English speaking
- No sex with another male in prior 12-months
- Not Black/African American or Hispanic identified
- HIV-positive, virally suppressed
- HIV-negative, not at high risk of HIV acquisition
- Unable or unwilling to provide consent for study participation
- Unable or unwilling to return for study visits
- Unwilling to provide an oral, blood or urine specimen for testing
- Currently taking pre-exposure prophylaxis (PrEP)
- Active or previous participation in an HIV vaccine trial
- Current participation in an adherence intervention (unless proof in the non-intervention arm)
- plan to relocate out of Baltimore, Washington DC, or Philadelphia in next 18- months
Natal Female Inclusion Criteria:
- Assigned female sex at birth
- English speaking
- 15-24 years old
- Have friends who are gay or bisexual males or transgender females
Natal Female Exclusion Criteria:
- Assigned male sex at birth
- Non-English speaking
- Under age 15
- Over age 24
- No report of friends who are gay or bisexual males or transgender females
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile-enhanced Engagement Intervention
Mobile-enhanced engagement intervention (MEI) to support HIV-positive and high risk HIV-negative participants achieve sustained engagement and sustained retention in HIV treatment or HIV prevention (PrEP) and substance use services at 18-months.
|
Mobile phone based enhanced case management intervention for HIV positive & HIV negative young Black men who have sex with men.
|
No Intervention: Control - SOC Case Management
Standard of care (SOC) case management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Viral Suppression
Time Frame: 18-months
|
Durable viral suppression (VL < 20 copies/ml)
|
18-months
|
PrEP Uptake
Time Frame: 18-months
|
Engagement in HIV pre-exposure prophylaxis (PrEP) services
|
18-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement in substance abuse treatment services
Time Frame: 6-months
|
Defined as at least two substance abuse treatment visits
|
6-months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Celentano, ScD, MHS, Johns Hopkins Bloomberg School of Public Health
- Principal Investigator: Renata Sanders, MD, ScM, MPH, Johns Hopkins Bloomberg School of Public Health and JHU School of Medicine
Publications and helpful links
General Publications
- Shorrock F, Alvarenga A, Hailey-Fair K, Vickroy W, Cos T, Kwait J, Trexler C, Wirtz AL, Galai N, Beyrer C, Celentano D, Arrington-Sanders R. Dismantling Barriers and Transforming the Future of Pre-Exposure Prophylaxis Uptake in Young Black and Latinx Sexual Minority Men and Transgender Women. AIDS Patient Care STDS. 2022 May;36(5):194-203. doi: 10.1089/apc.2021.0222.
- Arrington-Sanders R, Alvarenga A, Galai N, Arscott J, Wirtz A, Carr R, Lopez A, Beyrer C, Nessen R, Celentano D. Social Determinants of Transactional Sex in a Sample of Young Black and Latinx Sexual Minority Cisgender Men and Transgender Women. J Adolesc Health. 2022 Feb;70(2):275-281. doi: 10.1016/j.jadohealth.2021.08.002. Epub 2021 Sep 24.
- Arrington-Sanders R, Hailey-Fair K, Wirtz A, Cos T, Galai N, Brooks D, Castillo M, Dowshen N, Trexler C, D'Angelo LJ, Kwait J, Beyrer C, Morgan A, Celentano D; PUSH Study. Providing Unique Support for Health Study Among Young Black and Latinx Men Who Have Sex With Men and Young Black and Latinx Transgender Women Living in 3 Urban Cities in the United States: Protocol for a Coach-Based Mobile-Enhanced Randomized Control Trial. JMIR Res Protoc. 2020 Sep 16;9(9):e17269. doi: 10.2196/17269.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R01DA04308901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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