Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 11:59 AM
Study NCT ID:
NCT02772328
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCV-TTP
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: