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

Not Applicable

Completed

• Conditions: Risk Reduction Behavior; Hepatitis C; HIV
• Interventions: Behavioral: Peer Mentor

• Registration Number: NCT02772328
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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 Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Study Start: 2016-12-19
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Mentor	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.

Primary Outcome Measures

Name	Time	Method
Continuity in HIV care scale	24 months
Access to HCV care scale	24 months	Initiation of HCV care at a viral hepatitis clinic

Secondary Outcome Measures

Name	Time	Method
HIV medication adherence scale	24 months

Trial Locations

Locations (1)

Lighhouse Studies @ Peer Point; 🇺🇸 Baltimore, Maryland, United States