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Completed

NCT Number: NCT02772328

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

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.

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Key information

Conditions

Hepatitis C Behavior Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections HIV Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Risk Reduction Behavior Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lighhouse Studies @ Peer Point

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Mentor

Behavioral

comparison of communication training to equal attention control

Primary outcomes

  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 outcomes

  1. HIV medication adherence scale

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study 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

Acronym: HCV-TTP

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 13, 2016
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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