HIVNCT04193787
EPIC-P Intervention
A study testing EPIC-P in people with HIV, run by University of Connecticut at 1 site in United States.
Trial summary
This non-randomized, open-label study will address the following research aims in People who inject drugs (PWID): To assess the feasibility and acceptability of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk PWID. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- EPIC-P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 1 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residing in the Greater New Haven area;
- Confirmed HIV-negative;
- Reporting injection drug use (past 3 months) with substantial ongoing risk for HIV acquisition;
- Started on PrEP (within the last week).
Who cannot join
- Not on PrEP;
- Not available during the full duration of the study;
- Cannot speak English;
- Unable to provide consent;
- Anyone actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a consultant that is a licensed clinical psychologist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanding PrEP Implementation in Communities of People Who Inject Drugs and Their Risk Network Members
This non-randomized, open-label study will address the following research aims in People who inject drugs (PWID):
- To assess the feasibility and acceptability of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk PWID.
- To determine the preliminary efficacy of the EPIC-P intervention in terms of increasing adherence to PrEP and primary HIV prevention among high-risk PWID.
Read the detailed description
A non-randomized, open-label design will be utilized to test the feasibility, acceptability, and preliminary efficacy of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk people who inject drugs (PWID) with opioid dependence (N=100). Since the aim of this pilot study is to establish whether the EPIC-P intervention is feasible/acceptable among at-risk PWID in a community-based setting, proposed is a non-comparative design. With the hopes to target PWID who are not linked with existing harm reduction services, proposed is to recruit participants using respondent driven sampling (RDS), a chain referral method with demonstrated success in recruiting hard-to-reach populations. Initial RDS participants, called "seeds," will be carefully recruited from the community where the study team leadership have built a well-established relationship. Participants enrolled in the study will be assessed at baseline and will be followed for 9 months (with follow-up assessments at 3- and 6-months) by trained research assistants. Importantly, structured interviews will be conducted at follow-up visits to examine the barriers and facilitators and feedback about optimal implementation of the EPIC-P intervention.
- Conditions
- HIV
- Being tested
- EPIC-P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIC-POther
EPIC-P is a brief, bio-behavioral intervention based on the information-motivation-behavioral skills (IMB) model framework, which integrates i) a biomedical component (i.e., PrEP), ii) behavioral components (i.e., drug- and sex-related primary HIV prevention), and iii) mHealth technology (i.e., text messaging PrEP reminders).
| Study group | Role | What they receive |
|---|---|---|
| EPIC-P | Experimental | Participants will enroll in a bio-behavioral intervention aimed at preventing HIV transmission in people who inject drugs. Receives: Other: EPIC-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.
Measured: Up to 6 months
Secondary outcomes (5)
Acceptability
The acceptability will be assessed using a series of eight items acceptability rating profile. We will use a 5-point Likert scale (0= strongly disagree to 4= strongly agree) to rate the extend to which they agreed with each acceptability statement. A mean intervention acceptability score will be calculated with higher values indicating greater acceptability.
Measured: Up to 6 months
PrEP Adherence VAS
Adherence to PrEP will be assessed using a visual analog scale (VAS).
Measured: Up to 6 months
PrEP Adherence Pharmacy
Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants.
Measured: Up to 6 months
PrEP Adherence DBS
PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels.
Measured: Up to 6 months
HIV Incidence
HIV incidence will be tracked in participants through testing up to 6 months.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Sep 2020
- Primary completion1 Apr 2023
- Study completion1 Sep 2024
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 HIVStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Roman Shrestha, University of Connecticut
- Investigators
- Roman Shrestha, PhD, MPH, Principal investigator, Associate Research Scientist, Yale School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193787
- Sponsor's protocol ID
- E20-0594
- Status last verified
- Jan 2025
- First submitted
- 6 Dec 2019
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gautam K, Paudel K, Wickersham JA, Altice FL, Bellia G, Jadkarim L, Liew Z, Khati A, Copenhaver M, Shrestha R. Feasibility and acceptability of daily oral emtricitabine/tenofovir alafenamide fumarate (FTC/TAF) for HIV pre-exposure prophylaxis among people who inject drugs with opioid use disorder. Sex Transm Infect. 2026 Feb 10:sextrans-2025-056770. doi: 10.1136/sextrans-2025-056770. Online ahead of print.
PubMed 41667236
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding PrEP Implementation in Communities of People Who Inject Drugs and Their Risk Network Members
- ClinicalTrials.gov ID
- NCT04193787
- Acronym / sponsor ID
- E20-0594
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 10 Dec 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.
This non-randomized, open-label study will address the following research aims in People who inject drugs (PWID):
- To assess the feasibility and acceptability of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk PWID.
- To determine the preliminary efficacy of the EPIC-P intervention in terms of increasing adherence to PrEP and primary HIV prevention among high-risk PWID.
Detailed description
A non-randomized, open-label design will be utilized to test the feasibility, acceptability, and preliminary efficacy of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk people who inject drugs (PWID) with opioid dependence (N=100). Since the aim of this pilot study is to establish whether the EPIC-P intervention is feasible/acceptable among at-risk PWID in a community-based setting, proposed is a non-comparative design. With the hopes to target PWID who are not linked with existing harm reduction services, proposed is to recruit participants using respondent driven sampling (RDS), a chain referral method with demonstrated success in recruiting hard-to-reach populations. Initial RDS participants, called "seeds," will be carefully recruited from the community where the study team leadership have built a well-established relationship. Participants enrolled in the study will be assessed at baseline and will be followed for 9 months (with follow-up assessments at 3- and 6-months) by trained research assistants. Importantly, structured interviews will be conducted at follow-up visits to examine the barriers and facilitators and feedback about optimal implementation of the EPIC-P intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPIC-P | Experimental | Other: EPIC-PParticipants will enroll in a bio-behavioral intervention aimed at preventing HIV transmission in people who inject drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Residing in the Greater New Haven area;
- Confirmed HIV-negative;
- Reporting injection drug use (past 3 months) with substantial ongoing risk for HIV acquisition;
- Started on PrEP (within the last week).
Key exclusion criteria (5 listed)
- Not on PrEP;
- Not available during the full duration of the study;
- Cannot speak English;
- Unable to provide consent;
- Anyone actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a consultant that is a licensed clinical psychologist.
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 |
|---|---|---|
| EPIC-PEPIC-P is a brief, bio-behavioral intervention based on the information-motivation-behavioral skills (IMB) model framework, which integrates i) a biomedical component (i.e., PrEP), ii) behavioral components (i.e., drug- and sex-related primary HIV prevention), and iii) mHealth technology (i.e., text messaging PrEP reminders). | Other | EPIC-P |
Primary outcome
Retention Rate
Time frame: Up to 6 months
To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.
5 secondary outcomes
Acceptability
Time frame: Up to 6 months
PrEP Adherence VAS
Time frame: Up to 6 months
PrEP Adherence Pharmacy
Time frame: Up to 6 months
PrEP Adherence DBS
Time frame: Up to 6 months
HIV Incidence
Time frame: Up to 6 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 3 Feb 2025.
- Derived from this study: PubMed 41667236Gautam K, Paudel K, Wickersham JA, Altice FL, Bellia G, Jadkarim L, Liew Z, Khati A, Copenhaver M, Shrestha R. Feasibility and acceptability of daily oral emtricitabine/tenofovir alafenamide fumarate (FTC/TAF) for HIV pre-exposure prophylaxis among people who inject drugs with opioid use disorder. Sex Transm Infect. 2026 Feb 10:sextrans-2025-056770. doi: 10.1136/sextrans-2025-056770. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Roman Shrestha, PhD, MPH principal investigator
Associate Research Scientist, Yale School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPIC-P in people with HIV, run by University of Connecticut 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 4 inclusion and 5 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 3 Feb 2025. 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?
Retention Rate (time frame: Up to 6 months). 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 NCT04193787, 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 3 Feb 2025.