NCT03194477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

June 19, 2017

Last Update Submit

March 30, 2023

Conditions

HIV-1-infection

Keywords

HIV young Black men who have sex with men substance use

Outcome Measures

Primary Outcomes (2)

  • HIV Viral Suppression

    Durable viral suppression (VL \< 20 copies/ml)

    18-months

  • PrEP Uptake

    Engagement in HIV pre-exposure prophylaxis (PrEP) services

    18-months

Secondary Outcomes (1)

  • Engagement in substance abuse treatment services

    6-months

Study Arms (2)

Mobile-enhanced Engagement Intervention

EXPERIMENTAL

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

Control - SOC Case Management

NO INTERVENTION

Standard of care (SOC) case management.

Interventions

Mobile-enhanced Engagement InterventionBEHAVIORAL

Mobile phone based enhanced case management intervention for HIV positive \& HIV negative young Black men who have sex with men.

Mobile-enhanced Engagement Intervention

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Assigned male at birth
  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Adolescent and Young Adult Health at Johns Hopkins Harriet Lane

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

  • Arrington-Sanders R, Galai N, Falade-Nwulia O, Hammond C, Wirtz A, Beyrer C, Arteaga A, Celentano D. Patterns of Polysubstance Use in Young Black and Latinx Sexual Minority Men and Transgender Women and Its Association with Sexual Partnership Factors: The PUSH Study. Subst Use Misuse. 2024;59(3):317-328. doi: 10.1080/10826084.2023.2267655. Epub 2024 Jan 25.

    PMID: 38146133DERIVED

  • 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.

    PMID: 35507322DERIVED

  • 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.

    PMID: 34580030DERIVED

  • 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.

    PMID: 32935662DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Care providers and investigators will not know which patients are randomized to intervention or control.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

August 1, 2017

Primary Completion

May 28, 2021

Study Completion

September 6, 2022

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations

US(1)