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

HIV Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772328
• Other study ID #: 1R01DA040488
• Status: Completed
• Phase: N/A
• Start date: December 19, 2016
• Est. completion date: May 30, 2021

Study information

• Verified date: January 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV
• Risk Reduction Behavior

Intervention

Behavioral:
• Peer Mentor
comparison of communication training to equal attention control

Locations

Country	Name	City	State
United States	Lighhouse Studies @ Peer Point	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuity in HIV care scale		24 months
Primary	Access to HCV care scale	Initiation of HCV care at a viral hepatitis clinic	24 months
Secondary	HIV medication adherence scale		24 months