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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03194477|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Behavioral: Mobile-enhanced Engagement Intervention||Not Applicable|
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; and Philadelphia, PA (BWP) are disproportionately burdened by high rates of new cases of HIV infection, with disproportionate rates in young Black men who have sex with men (YBMSM) aged 15-24. High incidence underscores the need for increased identification, linkage and initiation in HIV and preventive care for YBMSM. 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 YBMSM living in BWP along the prevention and treatment continuum using the following aims:
Aim 1. Identify and recruit young (ages 15-24) Black men who have sex with men (YBMSM) in 3 urban cities who are (1) HIV-infected, not virally suppressed; and (2) high-risk HIV-uninfected YBMSM, including gender variant and questioning men, using respondent driven sampling (RDS) with targeted seed identification; 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 < 200 copies/ml) and substance treatment among 240 HIV-infected YBMSM who are not virally suppressed and recruited from RDS; and Aim 3. Modify and implement mobile-enhanced intervention for 225 high-risk HIV-uninfected YBMSM, recruited from RDS to promote linkage, retention and engagement of pre-exposure prophylaxis (PrEP) and substance treatment uptake over 12-months, comparing younger (15-19) and older (20-24) participants.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||465 participants|
|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, 2020|
|Estimated Study Completion Date :||June 30, 2021|
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 and 12-months respectively.
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.
- HIV Viral Suppression [ Time Frame: 12-months ]Durable viral suppression (VL < 200 copies/ml)
- PrEP Uptake [ Time Frame: 12-months ]Engagement in HIV pre-exposure prophylaxis (PrEP) services
- Engagement in substance abuse treatment services [ Time Frame: 6-months ]Defined as at least two substance abuse treatment visits
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 ClinicalTrials.gov identifier (NCT number): NCT03194477
|Contact: Anthony R Morganfirstname.lastname@example.org|
|Contact: Renata Sanders, MD, MPH, SCMemail@example.com|
|United States, Maryland|
|Center for Adolescent and Young Adult Health at Johns Hopkins Harriet Lane||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Anthony Morgan, BS 443-287-4993 firstname.lastname@example.org|
|Contact: Renata Arrington-Sanders, MD, ScM, MPH 410-502-8166 email@example.com|
|Principal Investigator: Renata Arrington-Sanders, MD, ScM, MPH|
|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|