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

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ClinicalTrials.gov Identifier: NCT01941108
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : June 2, 2016
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Drug Use Behavioral: Peer Navigation Arm Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care: The mPeer2Peer Study
Study Start Date : September 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. antiretroviral treatment (primary) [ Time Frame: 6 months ]
    patient initiated ART 6 months after randomization


Secondary Outcome Measures :
  1. viral suppression [ Time Frame: 6 months & 9 months ]
    undetectable viral load 6 months and 9 months after randomization

  2. antiretroviral treatment (secondary) [ Time Frame: 9 months ]
    patient initiated ART 9 months after randomization

  3. frequency of HIV care visits [ Time Frame: 1 year ]
    >3 HIV care visits within 1 year of randomization



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01941108


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Investigators
Principal Investigator: Gregory Kirk, MD, PhD, MPH Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01941108     History of Changes
Other Study ID Numbers: IRB00004654
R34DA033181-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: April 2015

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