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Providing Unique Support for Health (PUSH) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03194477
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : March 31, 2022
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
Project Narrative This 5-city proposal seeks to address HIV disparities among young (ages 15-24) Black and/or Latinx men who have sex with men (YBLMSM) and transgender women (YBLTW) in a multilevel intervention to identify, engage and retain, high-risk HIV-uninfected and HIV-infected urban YBMSM/TW in the HIV prevention and treatment cascade. The mobile-enhanced engagement intervention (MEI) is driven by the expressed and self-determined needs of each HIV infected and uninfected participant and includes care navigation, engagement, treatment and adherence. MEI also includes a supplemental Screening, Brief Intervention, and Referral for Treatment (SBIRT), to support YBLMSM/TW who face barriers accessing substance use treatment. By building upon existing case management services and flexibility to be adapted across ages and maturity and for prevention services, this intervention has the ability to transform networks, HIV and prevention care in YBLMSM/TW in cities with very high primary and secondary HIV transmission.

Condition or disease Intervention/treatment Phase
HIV-1-infection Behavioral: Mobile-enhanced Engagement Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mobile-enhanced engagement interventions (MEI) to support 1) HIV viral suppression among HIV-positive, not virally suppressed participants; 2) HIV-PrEP uptake among high-risk HIV-negative participants; and 3) engagement in substance abuse treatment for HIV-positive and HIV-negative participants.
Masking: Single (Care Provider)
Masking Description: Care providers and investigators will not know which patients are randomized to intervention or control.
Primary Purpose: Health Services Research
Official Title: Identifying and Engaging Urban HIV Infected and Uninfected YBMSM in Care
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
Behavioral: Mobile-enhanced Engagement Intervention
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.

Primary Outcome Measures :
  1. HIV Viral Suppression [ Time Frame: 18-months ]
    Durable viral suppression (VL < 20 copies/ml)

  2. PrEP Uptake [ Time Frame: 18-months ]
    Engagement in HIV pre-exposure prophylaxis (PrEP) services

Secondary Outcome Measures :
  1. Engagement in substance abuse treatment services [ Time Frame: 6-months ]
    Defined as at least two substance abuse treatment visits

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03194477

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United States, Maryland
Center for Adolescent and Young Adult Health at Johns Hopkins Harriet Lane
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute on Drug Abuse (NIDA)
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johns Hopkins Bloomberg School of Public Health Identifier: NCT03194477    
Other Study ID Numbers: 1R01DA04308901
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV young Black men who have sex with men substance use