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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 : September 16, 2020
Sponsor:
Collaborators:
University of North Carolina
University of Michigan
University of Minnesota
Emory University
Children's Hospital of Philadelphia
Baylor College of Medicine
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE April 24, 2017
First Posted Date  ICMJE April 27, 2017
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
Percent of Participants reporting changes in their HIV Testing Behavior using self-report questionnaires [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • 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 two or more times over the trial period.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Percent of participants reporting changes in PrEP uptake using self-report questionnaires [ 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.
  • Mean Change in motivations to engage in HIV prevention behaviors using self-report questionnaires [ 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 using the NIH Adolescent Trials Network's Harmonized Questionnaire by intervention group and by time on study.
  • Mean Change in PrEP motivations using self-report questionnaires [ 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 using the NIH Adolescent Trials Network's Harmonized Questionnaire.
  • Percent of Participants reporting changes in their STI Testing Behavior using self-report questionnaires [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Change in Number of Risky Sexual Partnerships [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
    The investigators will estimate the change in total number of sexual partners of known HIV positive or unknown HIV serostatus with whom participants had anal intercourse without condoms and/or PrEP during the follow-up period.
  • 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.
  • 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 over time.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Get Connected Efficacy Trial
Official Title  ICMJE Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Get Connected
  • 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.
    Intervention: Behavioral: AIDSVu
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jose A Bauermeister, PhD 2158989993 bjose@upenn.edu
Contact: Rob B Stephenson, PhD 7346470151 rbsteph@umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03132415
Other Study ID Numbers  ICMJE 1U19HD089881 (SubProject 8780)
1U19HD089881 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • University of North Carolina
  • University of Michigan
  • University of Minnesota
  • Emory University
  • Children's Hospital of Philadelphia
  • Baylor College of Medicine
Investigators  ICMJE
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
PRS Account University of Pennsylvania
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP