A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression (HCV-TTP)
Primary Purpose
Hepatitis C, HIV, Risk Reduction Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Mentor
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis C focused on measuring Testing, Access
Eligibility 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
Sites / Locations
- Lighhouse Studies @ Peer Point
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Peer Mentor
Neighborhood Matters
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Continuity in HIV care scale
Access to HCV care scale
Initiation of HCV care at a viral hepatitis clinic
Secondary Outcome Measures
HIV medication adherence scale
Full Information
NCT ID
NCT02772328
First Posted
May 10, 2016
Last Updated
January 19, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT02772328
Brief Title
A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression
Acronym
HCV-TTP
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2016 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HIV, Risk Reduction Behavior
Keywords
Testing, Access
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer Mentor
Arm Type
Experimental
Arm Description
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.
Arm Title
Neighborhood Matters
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Mentor
Intervention Description
comparison of communication training to equal attention control
Primary Outcome Measure Information:
Title
Continuity in HIV care scale
Time Frame
24 months
Title
Access to HCV care scale
Description
Initiation of HCV care at a viral hepatitis clinic
Time Frame
24 months
Secondary Outcome Measure Information:
Title
HIV medication adherence scale
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl A Latkin, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karin E Tobin, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lighhouse Studies @ Peer Point
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will work with NIH to determine sharing plan
Learn more about this trial
A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression
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