Hepatitis CHCV-TTPNCT02772328
A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression
A study testing Peer Mentor in people with Hepatitis C and HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, HIV, Risk Reduction Behavior
- What is being tested?
- Peer Mentor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2016to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- participated in a behavioral intervention in prior 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Lighhouse Studies @ Peer Point
Baltimore, Maryland, 21205
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis C, HIV, Risk Reduction Behavior
- Being tested
- Peer Mentor
- Keywords
- Testing, Access
- Medical subject headings
- Hepatitis C, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer MentorBehavioural
comparison of communication training to equal attention control
| Study group | Role | What they receive |
|---|---|---|
| Peer Mentor | Experimental | 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. Receives: Behavioral: Peer Mentor |
| Neighborhood Matters | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuity in HIV care scale
Measured: 24 months
Access to HCV care scale
Initiation of HCV care at a viral hepatitis clinic
Measured: 24 months
Secondary outcomes (1)
HIV medication adherence scale
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start19 Dec 2016
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl A Latkin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthKarin E Tobin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772328
- Sponsor's protocol ID
- 1R01DA040488
- Acronym
- HCV-TTP
- Status last verified
- Jan 2022
- First submitted
- 10 May 2016
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Will work with NIH to determine sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02772328
- Acronym / sponsor ID
- HCV-TTP / 1R01DA040488
- Conditions
- Hepatitis C, HIV, Risk Reduction Behavior
- Keywords
- Testing, Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Mentor | Experimental | Behavioral: Peer MentorIndividuals 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. |
| Neighborhood Matters | No intervention | –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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- participated in a behavioral intervention in prior 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Mentorcomparison of communication training to equal attention control | Behavioural | Peer Mentor |
Primary outcome
Continuity in HIV care scale
Time frame: 24 months
Access to HCV care scale
Time frame: 24 months
Initiation of HCV care at a viral hepatitis clinic
1 secondary outcome
HIV medication adherence scale
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: Undecided. Will work with NIH to determine sharing plan
Related trials for Hepatitis C
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HCV Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl A Latkin, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Karin E Tobin, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Mentor in people with Hepatitis C and HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuity in HIV care scale (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.