HIV PreventionM2HepPrEPNCT03981445
Integrated HIV Prevention and HCV Care for PWID
A study testing ARTAS Adapted Patient Navigation and Adherence Counseling in people with HIV Prevention and HCV, run by Columbia University at 3 sites in 2 countries.
Trial summary
The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HCV, Opioid Use
- What is being tested?
- ARTAS Adapted Patient Navigation and Adherence Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Nov 2019to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals must meet the following criteria to be eligible to participate in the RCT:
- Be 18-64 years of age
- report injection drug use in the past 6-months
- be HIV negative
- provide informed consent
- complete a medical release form
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- report living in the vicinity and being able to return for follow-up over 18-months
- be willing to use a medically acceptable form of contraception throughout the study duration (for women of childbearing potential)
- be able to communicate in English or French (site dependent)
- be receiving services at an opioid agonist therapy clinic or a syringe access program
- Individuals must meet the following criteria to be eligible to participate in the qualitative interview:
- have completed the first 6 months of RCT follow up (RCT participant interviews);
- provide informed consent;
- have contributed to assessments/interviews, intervention and/or treatment follow-ups (staff interviews).
Who cannot join
- Individuals will be excluded from the RCT if they:
- have any disabling medical conditions as assessed by medical history, physical exam, vital signs, and/or laboratory assessments that in the opinion of the study physician preclude safe participation in the study or ability to provide fully informed consent.
- have any disabling mental conditions as assessed by medical history and clinical assessment that in the opinion of the study physician precludes safe participation in the study or ability to provide fully informed consent.
- have chronic renal failure
- have or have history of decompensated cirrhosis
- are HIV-positive or have symptoms of an acute HIV infection
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- are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding
- have an allergy or contraindication to one of the study medications
- have prior HCV treatment failure with direct-acting antiviral (DAA) regimens (Except those who were treated, cured the virus, but were re-infected with a new virus)
- are currently on PrEP and/or HCV treatment.
- are currently in prison, in any inpatient overnight facility as required by court of law or have a pending legal action, which may prevent an individual from completing the study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Miami
Miami, Florida, 33136
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: A Multi-site Multi-Setting Randomized Controlled Trial (RCT) of Integrated HIV Prevention and HCV Care for People Who Inject Drugs (PWID)
The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Participants will be randomized to one of two treatment arms: on-site integrated care or off-site referral to specialized care.
Read the detailed description
The first strategy, the on-site integrated care model, provides opioid agonist therapy (OAT) clinics and harm reduction sites/syringe access programs (SAP) with the tools to offer HIV prevention and HCV treatment on-site. The second strategy, the off-site referrals to specialized care model, connects people who are at risk for contracting HIV with patient navigators who help them access available HIV prevention care and, if necessary, HCV treatment.
- Conditions
- HIV Prevention, HCV, Opioid Use, Intravenous Drug Usage
- Being tested
- ARTAS Adapted Patient Navigation, Adherence Counseling
- Keywords
- PrEP, HCV Treatment, Injection Drug Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTAS Adapted Patient NavigationBehavioural
Patient navigation will provided by trained patient navigators to participants randomized to the off-site referral to specialized care arm. Patient Navigators will actively coordinate and link participants to available clinics and community resources by scheduling appointments, arranging transportation, and assisting the participant with completing any paperwork that a clinic or service agent may require. The intervention will include up to five, 30-45 minute face-to-face meetings between the patient navigator and participant. These meetings will be tailored around each participant's needs. Additionally, the patient navigator assists the participant in identifying and utilizing informal and formal sources of support to move along the PrEP and/or HCV care continuum.The patient navigator will help the participant inform off-site physicians of the trial and of the availability of PrEP and HCV medication, should the physician and patient decide to initiate one or both treatments.
Adherence CounselingBehavioural
Counseling for PrEP initiation and adherence and, if necessary, HCV treatment will be provided by the clinical counseling staff of the on-site integrated care arm. Adherence counseling will include, but not be limited to, the indications, advantages, and disadvantages (e.g. side effects) of PrEP and HCV treatment in order to help the participant with his/her decision. The counselor will provide any necessary information to the participants and help them to address health and social needs. If required, the counselor will help the patient and physician with insurance-related issues. Adherence counselling will be carried out in a motivational style. The intervention will include five 30-45 minute face-to-face meetings with the participant and the adherence counselor over 6 months.
| Study group | Role | What they receive |
|---|---|---|
| On-site Integrated Care with Adherence Counseling | Experimental | Participants randomized to the on-site integrated care with adherence counselling arm will be prescribed pre-exposure prophylaxis (PrEP) (Truvada®) and, if indicated, Hepatitis C (HCV) treatment (Epclusa®) at the OAT clinic or SAP from which they were recruited. In addition to PrEP and, if indicated, HCV care, participants in the on-site integrated care arm will receive any required health care services as per local standard of care. Addiction treatment, OAT, and mental health services will be provided, if necessary and available. Participants recruited at syringe access programs (SAP) will be offered addiction counseling and treatment, including OAT when in the integrated care arm in addition to site standard of care. Receives: Behavioral: Adherence Counseling |
| Off-site Referral to Specialized Care with Patient Navigation | Experimental | Participants randomized to the off-site referral to specialized care and patient navigation group will be linked to primary care for PrEP and, if necessary, HCV treatment by a patient navigator. Given the replicated success of the AntiRetroviral Treatment Access Study (ARTAS) intervention regarding linking HIV-infected individuals to HIV primary care, we adapted ARTAS to facilitate people who inject drugs linkage with PrEP and, if necessary, HCV treatment services. Participants in the off-site care arm will be prescribed PrEP and, if necessary, HCV treatment by their off-site physician. All necessary care will also be provided to participants by their off-site physician. Off-site physicians will be notified that if their patients are placed on a waiting list, unable to afford, or are otherwise unable to immediately access PrEP or HCV treatment, Truvada® and Epclusa® are available to participants of the M2HepPrEP study immediately and free of charge. Receives: Behavioral: ARTAS Adapted Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained PrEP adherence
Average proportion of Dried Blood Spots (DBS) with detectable levels of Tenofovir at 6 months
Measured: 6 months post randomization
HCV cure among HCV positive strata
HCV cure among the HCV positive strata will be compared between both treatment arms at 12 months post randomization. HCV cure is defined as initiating HCV treatment within six (6) months of being randomized and achieving sustained viral response 12 weeks (SVR-12) post-treatment completion. HCV treatment initiation will be measured using self-report and by assessing medical/drug dispensation records. SVR-12 will be measured by testing HCV-RNA negative 12 weeks after end of HCV treatment. If a participant initiates treatment within six (6) months of randomization but does not achieve SVR-12, they will not be counted as a success. Likewise, if a participant who is randomized as HCV positive achieves SVR-12 but did not initiate treatment within 6-months of randomization, they will not be counted as a success.
Measured: 6-months post treatment initiation
Secondary outcomes (5)
Long-term sustained PrEP Adherence
Proportion of participants who self-report PrEP use and achieve detectable levels of tenofovir as measured by DBS testing at 6 months and 12 months post randomization.
Measured: Up to 12 months
Behavioral disinhibition
Proportion of participants who increase sexual or injection risk behaviors as measured by self- report questionnaires administered at each research visit.
Measured: Up to 12 months
STI or HIV incidence
Sexually Transmitted Infections (STI) incidence will be defined as a positive test result for Neisseria gonorrhoeae, Chlamydia trachomatis, HIV or syphilis in participants who formerly tested negative for the STI(s).
Measured: Up to 12 months
HCV Incidence
HCV status will be determined by HCV-Ab testing, and if positive, HCV-RNA testing. New incidence of HCV will be defined as an HCV-Ab positive test results in participants who were HCV-Ab negative at a previous testing visit and HCV-Ab positive/HCV-RNA positive test results in participants who had previously tested HCV-Ab positive/HCV-RNA negative
Measured: Up to 12 months
PrEP Initiation/Uptake
Proportion of participants who initiate PrEP before 6 months post randomization and between 6 to 12 months post randomization. PrEP initiation will be defined as record of dispensation of the first dose of TDF/FTC to a participant.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start14 Nov 2019
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is an open-label, multi-site, multi-center, randomized, controlled,superiority trial with two parallel treatment arms. The study is a type-1 hybrid effectiveness implementation study. Participants will be randomized to the on-site integrated care with adherence counselling treatment or the off-site referral to specialized care group with patient navigation in a 1:1 ratio using a permuted-block randomization scheme.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, University of Miami, Weill Medical College of Cornell University, Université de Sherbrooke, Simon Fraser University, National Institute on Drug Abuse (NIDA), Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Principal investigator, Lisa Metsch, Columbia University
- Investigators
- Lisa R Metsch, Ph.D, Principal investigator, Columbia UniversityJulie Bruneau, M.D., Principal investigator, Université de MontréalDaniel Feaster, Ph.D, Principal investigator, University of MiamiValérie Martel-Laferrière, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981445
- Sponsor's protocol ID
- AAAR5478
- Other IDs
- R01DA045713
- Acronym
- M2HepPrEP
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martel-Laferriere V, Feaster DJ, Metsch LR, Schackman BR, Loignon C, Nosyk B, Tookes H, Behrends CN, Arruda N, Adigun O, Goyer ME, Kolber MA, Mary JF, Rodriguez AE, Yanez IG, Pan Y, Khemiri R, Gooden L, Sako A, Bruneau J. M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID. Trials. 2022 Apr 23;23(1):341. doi: 10.1186/s13063-022-06085-3.
PubMed 35461260
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Multi-Setting Randomized Controlled Trial (RCT) of Integrated HIV Prevention and HCV Care for People Who Inject Drugs (PWID)
- ClinicalTrials.gov ID
- NCT03981445
- Acronym / sponsor ID
- M2HepPrEP / AAAR5478
- Conditions
- HIV Prevention, HCV, Opioid Use, Intravenous Drug Usage
- Keywords
- PrEP, HCV Treatment, Injection Drug Use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Université de Montréal, University of Miami, Weill Medical College of Cornell University, Université de Sherbrooke, Simon Fraser University, National Institute on Drug Abuse (NIDA), Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Jun 2019 (actual)
- 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 objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Participants will be randomized to one of two treatment arms: on-site integrated care or off-site referral to specialized care.
Detailed description
The first strategy, the on-site integrated care model, provides opioid agonist therapy (OAT) clinics and harm reduction sites/syringe access programs (SAP) with the tools to offer HIV prevention and HCV treatment on-site. The second strategy, the off-site referrals to specialized care model, connects people who are at risk for contracting HIV with patient navigators who help them access available HIV prevention care and, if necessary, HCV treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is an open-label, multi-site, multi-center, randomized, controlled,superiority trial with two parallel treatment arms. The study is a type-1 hybrid effectiveness implementation study. Participants will be randomized to the on-site integrated care with adherence counselling treatment or the off-site referral to specialized care group with patient navigation in a 1:1 ratio using a permuted-block randomization scheme.
| Arm | Type | Receives |
|---|---|---|
| On-site Integrated Care with Adherence Counseling | Experimental | Behavioral: Adherence CounselingParticipants randomized to the on-site integrated care with adherence counselling arm will be prescribed pre-exposure prophylaxis (PrEP) (Truvada®) and, if indicated, Hepatitis C (HCV) treatment (Epclusa®) at the OAT clinic or SAP from which they were recruited. In addition to PrEP and, if indicated, HCV care, participants in the on-site integrated care arm will receive any required health care services as per local standard of care. Addiction treatment, OAT, and mental health services will be provided, if necessary and available. Participants recruited at syringe access programs (SAP) will be offered addiction counseling and treatment, including OAT when in the integrated care arm in addition to site standard of care. |
| Off-site Referral to Specialized Care with Patient Navigation | Experimental | Behavioral: ARTAS Adapted Patient NavigationParticipants randomized to the off-site referral to specialized care and patient navigation group will be linked to primary care for PrEP and, if necessary, HCV treatment by a patient navigator. Given the replicated success of the AntiRetroviral Treatment Access Study (ARTAS) intervention regarding linking HIV-infected individuals to HIV primary care, we adapted ARTAS to facilitate people who inject drugs linkage with PrEP and, if necessary, HCV treatment services. Participants in the off-site care arm will be prescribed PrEP and, if necessary, HCV treatment by their off-site physician. All necessary care will also be provided to participants by their off-site physician. Off-site physicians will be notified that if their patients are placed on a waiting list, unable to afford, or are otherwise unable to immediately access PrEP or HCV treatment, Truvada® and Epclusa® are available to participants of the M2HepPrEP study immediately and free of charge. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Be 18-64 years of age
- report injection drug use in the past 6-months
- be HIV negative
- provide informed consent
- complete a medical release form
Key exclusion criteria (11 listed)
- have any disabling medical conditions as assessed by medical history, physical exam, vital signs, and/or laboratory assessments that in the opinion of the study physician preclude safe participation in the study or ability to provide fully informed consent.
- have any disabling mental conditions as assessed by medical history and clinical assessment that in the opinion of the study physician precludes safe participation in the study or ability to provide fully informed consent.
- have chronic renal failure
- have or have history of decompensated cirrhosis
- are HIV-positive or have symptoms of an acute HIV infection
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 |
|---|---|---|
| ARTAS Adapted Patient NavigationPatient navigation will provided by trained patient navigators to participants randomized to the off-site referral to specialized care arm. Patient Navigators will actively coordinate and link participants to available clinics and community resources by scheduling appointments, arranging transportation, and assisting the participant with completing any paperwork that a clinic or service agent may require. The intervention will include up to five, 30-45 minute face-to-face meetings between the patient navigator and participant. These meetings will be tailored around each participant's needs. Additionally, the patient navigator assists the participant in identifying and utilizing informal and formal sources of support to move along the PrEP and/or HCV care continuum.The patient navigator will help the participant inform off-site physicians of the trial and of the availability of PrEP and HCV medication, should the physician and patient decide to initiate one or both treatments. | Behavioural | Off-site Referral to Specialized Care with Patient Navigation |
| Adherence CounselingCounseling for PrEP initiation and adherence and, if necessary, HCV treatment will be provided by the clinical counseling staff of the on-site integrated care arm. Adherence counseling will include, but not be limited to, the indications, advantages, and disadvantages (e.g. side effects) of PrEP and HCV treatment in order to help the participant with his/her decision. The counselor will provide any necessary information to the participants and help them to address health and social needs. If required, the counselor will help the patient and physician with insurance-related issues. Adherence counselling will be carried out in a motivational style. The intervention will include five 30-45 minute face-to-face meetings with the participant and the adherence counselor over 6 months. | Behavioural | On-site Integrated Care with Adherence Counseling |
Primary outcome
Sustained PrEP adherence
Time frame: 6 months post randomization
Average proportion of Dried Blood Spots (DBS) with detectable levels of Tenofovir at 6 months
HCV cure among HCV positive strata
Time frame: 6-months post treatment initiation
HCV cure among the HCV positive strata will be compared between both treatment arms at 12 months post randomization. HCV cure is defined as initiating HCV treatment within six (6) months of being randomized and achieving sustained viral response 12 weeks (SVR-12) post-treatment completion. HCV treatment initiation will be measured using self-report and by assessing medical/drug dispensation records. SVR-12 will be measured by testing HCV-RNA negative 12 weeks after end of HCV treatment. If a participant initiates treatment within six (6) months of randomization but does not achieve SVR-12, they will not be counted as a success. Likewise, if a participant who is randomized as HCV positive achieves SVR-12 but did not initiate treatment within 6-months of randomization, they will not be counted as a success.
5 secondary outcomes
Long-term sustained PrEP Adherence
Time frame: Up to 12 months
Behavioral disinhibition
Time frame: Up to 12 months
STI or HIV incidence
Time frame: Up to 12 months
HCV Incidence
Time frame: Up to 12 months
PrEP Initiation/Uptake
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 35461260Martel-Laferriere V, Feaster DJ, Metsch LR, Schackman BR, Loignon C, Nosyk B, Tookes H, Behrends CN, Arruda N, Adigun O, Goyer ME, Kolber MA, Mary JF, Rodriguez AE, Yanez IG, Pan Y, Khemiri R, Gooden L, Sako A, Bruneau J. M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID. Trials. 2022 Apr 23;23(1):341. doi: 10.1186/s13063-022-06085-3.
- Related InfoLink provided by the sponsor.
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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.
Lisa R Metsch, Ph.D principal investigator
Columbia University
Julie Bruneau, M.D. principal investigator
Université de Montréal
Daniel Feaster, Ph.D principal investigator
University of Miami
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTAS Adapted Patient Navigation and Adherence Counseling in people with HIV Prevention and HCV, run by Columbia University at 3 sites in 2 countries.
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 14 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sustained PrEP adherence (time frame: 6 months post randomization). 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?
On the ClinicalTrials.gov record for NCT03981445, which also lists 1 linked publication.
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 15 Jun 2026.