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Trial record 1 of 1 for:    NCT03132415
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Get Connected Efficacy Trial

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ClinicalTrials.gov Identifier: NCT03132415
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
University of North Carolina
University of Michigan
University of Minnesota - Clinical and Translational Science Institute
Emory University
Children's Hospital of Philadelphia
Texas Children's Hospital
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
Get Connected (GC) is an online brief intervention that employs individual and systems-level tailoring technology to reduce barriers to HIV prevention care (e.g., HIV/STI testing, PrEP) for YMSM. The deployment of GC through a mobile-friendly WebApp seeks to optimize online interventions' acceptability, accessibility, availability, long-term affordability among youth. The investigators will enroll 480 self-reported HIV-negative or sero-status unaware, sexually active YMSM (ages 15-24) across three cities and randomize them into the GC intervention condition or to an attention-control condition. Assessments will be collected at 30 days and at 3, 6, 9 and 12 month follow-up.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Get Connected Behavioral: AIDSVu Not Applicable

Detailed Description:

The number of HIV infections among men who have sex with men aged 15-24 (YMSM) has grown significantly in the past decade. For YMSM to successfully engage in HIV prevention and care services requires that they navigate a series of multilevel barriers operating at the individual (e.g., risk awareness, self-efficacy to get tested), systems (e.g., costs, medical mistrust, lack of culturally competent care), and structural (e.g., homelessness, costs, stigma) levels.

The investigators developed Get Connected (GC) as an online brief intervention that employs individual and systems-level tailoring technology to reduce barriers to linkage to competent prevention care (e.g., HIV/STI testing, PrEP) for YMSM (ages 15-24). After a formative phase comprised of assessing HIV testing sites' performance via a mystery shopping procedure, the investigators will test the efficacy of GC for increasing YMSM's successful engagement in locally appropriate HIV prevention and care using a two-arm randomized controlled trial.

The trial will compare GC (N=240) to an existing online HIV test locator (N=240). Participants will be recruited from three cities (Houston, Philadelphia and Atlanta) characterized by high HIV incidence, and followed over 12 months. Assessments will be collected at 30 days and at 3, 6, 9 and 12 month follow-up.

Specific Aims include:

Aim 1: Examine the quality of HIV test counseling and PrEP-related referrals to YMSM within local HIV/STI testing sites in 3 cities (Houston, Philadelphia & Atlanta).

Aim 2: Test the efficacy of GC for increasing HIV-negative or HIV-unknown YMSM's successful uptake of HIV prevention services (e.g., routine HIV/STI testing) and PrEP awareness and willingness, as compared to the attention-control condition over a 12-month period.

Aim 3: Qualitatively assess sites' satisfaction with performance assessments and their improvements in service delivery when working with YMSM across the three regions.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Get Connected
Get Connected is a brief intervention focused on resolving ambivalence about HIV prevention behaviors, increasing self-efficacy for change, and enhancing motivation moving toward action.
Behavioral: Get Connected
The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics, HIV/STI testing history and testing motivations, and recent sexual behaviors.

Active Comparator: Non-tailored HIV Test Locator
Participants randomized to the control condition will be directed to a website that includes information on the AIDSVU.org testing site locator. Given the availability of search engines to locate HIV/STI testing sites, the test locator condition may be considered usual care.
Behavioral: AIDSVu
The investigators will use AIDSVu's available HIV/STI testing locator as the attention-control condition. The AIDSVu test locator provides a list of HIV testing sites in a city or zipcode.




Primary Outcome Measures :
  1. Change in HIV Testing Behavior [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
    The investigators will estimate the proportion of participants who test for HIV by intervention group and by time on study.


Secondary Outcome Measures :
  1. Changes in PrEP Uptake [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
    The investigators will test the proportion of the sample that begins PrEP during the 12-month follow-ups.

  2. Changes in motivations to engage in HIV prevention behaviors [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
    The investigators will measure the change in HIV prevention attitudes, norms, and self-efficacy by intervention group and by time on study.

  3. Change in PrEP motivations [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
    The investigators will measure the change in PrEP awareness and willingness over time.

  4. Change in STI Testing Behavior [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
    The investigators will estimate the proportion of participants who test for STIs at least once over the trial period.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Assigned male sex at birth and currently identifies as male
  • Aged 15 to 24 years (inclusive) at time of screening
  • Self-report as HIV-negative or sero-status unaware
  • Speak and read English
  • Not be on PrEP at time of enrollment
  • Report having consensual anal sex with a male partner in the prior 6 months
  • Reside in Philadelphia, Houston, or Atlanta
  • Access to internet

Exclusion Criteria:

  • Assigned female sex at birth
  • Assigned male sex at birth but identifies as transgender or gender non-conforming
  • Aged 14 years or younger or 25 years or older at time of screening
  • HIV-positive
  • Does not speak or read English
  • Currently taking PrEP
  • Did not have consensual anal sex with a male partner in the prior 6 months
  • Does not reside in Philadelphia, Houston, or Atlanta
  • Currently incarcerated
  • Planning to move out of the region in next 12 months

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 ClinicalTrials.gov identifier (NCT number): NCT03132415


Contacts
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Contact: Jose A Bauermeister, PhD 2158989993 bjose@upenn.edu
Contact: Rob B Stephenson, PhD 7346470151 rbsteph@umich.edu

Locations
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United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Mondie Tharp, MPH    404-712-2224    Mondie.b.tharp@emory.edu   
Principal Investigator: Patrick S Sullivan, PhD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nadia Dowshen, MD    215-590-3749    dowshenn@email.chop.edu   
Contact: Anna Schlupp, BS    215-370-6446    schluppa@email.chop.edu   
Sub-Investigator: Marne Castillo, PhD         
United States, Texas
Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Dalisa Santiago    832-824-1143    dxsantia@texaschildrens.org   
Principal Investigator: Mary E Paul, MD         
Sponsors and Collaborators
University of Pennsylvania
University of North Carolina
University of Michigan
University of Minnesota - Clinical and Translational Science Institute
Emory University
Children's Hospital of Philadelphia
Texas Children's Hospital
Investigators
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Study Chair: Lisa Hightow-Weidman, MD University of North Carolina
Principal Investigator: Jose A Bauermeister, PhD University of Pennsylvania
Principal Investigator: Rob B Stephenson, PhD University of Michigan
Study Chair: Patrick S Sullivan, PhD Emory University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03132415     History of Changes
Other Study ID Numbers: 1U19HD089881 (SubProject 8780)
1U19HD089881 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.

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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 University of Pennsylvania:
Prevention & Control
Internet
Adolescents
Young adults

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases