Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care (mP2P)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01941108
First received: September 4, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

The purpose of the mPeer2Peer Study (mP2P) is to see if we can use a smartphone and a Peer Navigator (PN) to improve medical care for HIV-positive people who have been out of HIV care for over one year.


Condition Intervention
HIV
Drug Use
Behavioral: Peer Navigation Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care: The mPeer2Peer Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • antiretroviral treatment (primary) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    patient initiated ART 6 months after randomization


Secondary Outcome Measures:
  • viral suppression [ Time Frame: 6 months & 9 months ] [ Designated as safety issue: No ]
    undetectable viral load 6 months and 9 months after randomization

  • antiretroviral treatment (secondary) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    patient initiated ART 9 months after randomization

  • frequency of HIV care visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    >3 HIV care visits within 1 year of randomization


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard HIV Care Arm
Patients in the standard HIV care arm will be escorted to their first HIV care appointment at the Moore Clinic at Johns Hopkins University Hospital. They will not receive any additional intervention regarding their care after that. Participants in this arm will be followed up by the study coordinator every 3 months for 9 months.
Experimental: Peer Navigation Arm
Patients in the peer navigation arm will be escorted to their first HIV care appointment at the Moore Clinic at Johns Hopkins University Hospital. They will be assigned to a peer navigator who can assist them in overcoming obstacles to their HIV care. They will be given a smartphone with specialized software to help with their navigation. Participants in this arm will be followed up by the study coordinator every 3 months for 9 months and interact with their navigator when necessary.
Behavioral: Peer Navigation Arm
Patients randomized to this arm receive regular contact with a peer navigator and a smartphone running eMOCHA software to aid in navigation.
Other Names:
  • eMOCHA
  • smartphone
  • PN

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of current or former injection drug use
  • No clinic visits with an HIV provider in the preceding 12 months
  • Not taking ART
  • HIV RNA level of greater than 1,000 copies/mL
  • Agree to attend at least one HIV care visit at the Johns Hopkins Moore clinic

Exclusion Criteria:

  • Any medical or psychiatric condition that would interfere with the participant's ability to comply with study procedures or make participation unsafe
  • Current enrollment in another HIV retention-in-care study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941108

Contacts
Contact: Andrew Genz, MPH 4105029640 agenz@jhsph.edu
Contact: Laira Lucas, BS 4432875181 llucas@jhsph.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Andrew Genz, MPH    410-502-9640    agenz@jhsph.edu   
Contact: Laira Lucas, BS    4432875181    llucas@jhsph.edu   
Principal Investigator: Gregory Kirk, MD, PhD, MPH         
Sub-Investigator: Ryan Westergaard, MD, PhD, MPH         
Sub-Investigator: Keruly Jeanne, CRNP         
Sub-Investigator: Larry Chang, MD, MPH         
Sub-Investigator: Robert Bollinger, MD, MPH         
Sub-Investigator: Heidi Hutton, PhD         
Sub-Investigator: Pamela Surkan, PhD, ScD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
University of Wisconsin, Madison
Investigators
Principal Investigator: Gregory Kirk, MD, PhD, MPH Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01941108     History of Changes
Other Study ID Numbers: IRB00004654, R34DA033181-01A1
Study First Received: September 4, 2013
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
AIDS
peer navigation
ecological momentary assessment
eMOCHA
Baltimore
IDU

ClinicalTrials.gov processed this record on October 20, 2014