NCT01941108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 6, 2022

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

September 4, 2013

Last Update Submit

October 3, 2022

Conditions

Keywords

AIDSpeer navigationecological momentary assessmenteMOCHABaltimoreIDU

Outcome Measures

Primary Outcomes (1)

  • antiretroviral treatment (primary)

    patient initiated ART 6 months after randomization

    6 months

Secondary Outcomes (3)

  • viral suppression

    6 months & 9 months

  • antiretroviral treatment (secondary)

    9 months

  • frequency of HIV care visits

    1 year

Study Arms (2)

Standard HIV Care Arm

NO INTERVENTION

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.

Peer Navigation Arm

EXPERIMENTAL

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

Interventions

Patients randomized to this arm receive regular contact with a peer navigator and a smartphone running eMOCHA software to aid in navigation.

Also known as: eMOCHA, smartphone, PN
Peer Navigation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • Westergaard RP, Genz A, Panico K, Surkan PJ, Keruly J, Hutton HE, Chang LW, Kirk GD. Acceptability of a mobile health intervention to enhance HIV care coordination for patients with substance use disorders. Addict Sci Clin Pract. 2017 Apr 26;12(1):11. doi: 10.1186/s13722-017-0076-y.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Gregory Kirk, MD, PhD, MPH

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 6, 2022

Record last verified: 2015-04

Data Sharing

IPD Sharing
Will not share

Locations