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HIV-1-infectionNCT03194477

Providing Unique Support for Health (PUSH) Study

A study testing Mobile-enhanced Engagement Intervention in people with HIV-1-infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 24 yearsHealthy volunteers can take part
Conditions the study is for
HIV-1-infection
What is being tested?
Mobile-enhanced Engagement Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
631 participants
Where
1 siteUnited States
Study dates
1 Aug 2017to 6 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Identifying and Engaging Urban HIV Infected and Uninfected YBMSM in Care

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.

Read the 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.

Conditions
HIV-1-infection
Being tested
Mobile-enhanced Engagement Intervention
Keywords
HIV young Black men who have sex with men substance use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile-enhanced Engagement InterventionBehavioural

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

Study groups in NCT03194477
Study groupRoleWhat they receive
Mobile-enhanced Engagement InterventionExperimentalMobile-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.
Receives: Behavioral: Mobile-enhanced Engagement Intervention
Control - SOC Case ManagementNo interventionStandard of care (SOC) case management.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV Viral Suppression

    Durable viral suppression (VL < 20 copies/ml)

    Measured: 18-months

  2. PrEP Uptake

    Engagement in HIV pre-exposure prophylaxis (PrEP) services

    Measured: 18-months

Secondary outcomes (1)

  1. Engagement in substance abuse treatment services

    Defined as at least two substance abuse treatment visits

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2017
  2. Study start1 Aug 2017
  3. Primary completion28 May 2021
  4. Study completion6 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Care provider
Enrolment
631 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03194477
Sponsor's protocol ID
1R01DA04308901
Status last verified
Mar 2023
First submitted
19 Jun 2017
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers.

Publications

  • 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.

    PubMed 38146133

  • 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.

    PubMed 35507322

  • 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.

    PubMed 34580030

  • 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.

    PubMed 32935662

Questions about this trial

What is this clinical trial studying?

A study testing Mobile-enhanced Engagement Intervention in people with HIV-1-infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV Viral Suppression (time frame: 18-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194477, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.

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Providing Unique Support for Health (PUSH) Study | AzTrials