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A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression (HCV-TTP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772328
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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Brief Summary:
The purpose of this study is to test an intervention designed to train persons who inject drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1) promote new HCV treatment and care 2) risk reduction and 3) recruit their social network members for HIV and HCV testing and linkage to care.

Condition or disease Intervention/treatment Phase
Hepatitis C HIV Risk Reduction Behavior Behavioral: Peer Mentor Not Applicable

Detailed Description:
The investigators propose recruiting 300 HIV/HCV co-infected PWID (i.e. Index participants). Half will be randomly assigned to the experimental condition and half to the equal attention comparison. The experimental intervention will include 8 group sessions that focus on communication to social network members, medical adherence and risk reduction skills, 2 dyad sessions with network members, monthly booster sessions for 6 months, and mHealth cuing of behavior for 6 months. These Index participants will be followed for 24 months (3, 6, 12, 18, & 24 month assessments). Participants who test positive for HCV will be linked to the Johns Hopkins Viral Hepatitis clinic to assess liver function and HCV chronicity and if applicable offered HCV treatment. Additionally, 450 network members will be recruited and will be tested for HIV and HCV and followed longitudinally to examine the social diffusion and social network factors associated with adherence among the Index participants.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial of a Social-network Oriented Mobile Health Based Intervention to Increase Access and Adherence to Hepatitis C Treatment and HIV Viral Suppression
Actual Study Start Date : December 19, 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Peer Mentor
Individuals in this arm will be trained in communication skills to promote HIV and HCV testing to their social network members, linkage to care and risk reduction behaviors.
 Behavioral: Peer Mentor
comparison of communication training to equal attention control
No Intervention: Neighborhood Matters
Participants in this arm will view a 15-20 minute video on issues in neighborhoods such as crime and violence, restoring communities and incarceration and discuss their reactions and thoughts.


Outcome Measures
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Primary Outcome Measures :
  1. Continuity in HIV care scale [ Time Frame: 24 months ]
  2. Access to HCV care scale [ Time Frame: 24 months ]
    Initiation of HCV care at a viral hepatitis clinic


Secondary Outcome Measures :
  1. HIV medication adherence scale [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HCV antibody positive
  • HIV antibody positive
  • lifetime history of injection drug use
  • interrupted HIV care:>3 months since HIV care or detectable viral load
  • willingness to participate in group sessions and have conversations with social network members

Exclusion Criteria:

- participated in a behavioral intervention in prior 2 years

Contacts and Locations
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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): NCT02772328


Locations
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United States, Maryland
Lighhouse Studies @ Peer Point
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Carl A Latkin, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Karin E Tobin, PhD Johns Hopkins Bloomberg School of Public Health
More Information
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02772328    
Other Study ID Numbers: 1R01DA040488 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will work with NIH to determine sharing plan
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Testing
Access
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections