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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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This non-randomized, open-label study will address the following research aims in People who inject drugs (PWID):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPIC-P | Experimental | Participants will enroll in a bio-behavioral intervention aimed at preventing HIV transmission in people who inject drugs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPIC-P | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Shrestha, PhD, MPH | Associate Research Scientist, Yale School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Storefront | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41667236 | Derived | 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. |
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| PrEP Adherence VAS | Adherence to PrEP will be assessed using a visual analog scale (VAS). | Up to 6 months |
| PrEP Adherence Pharmacy | Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants. | Up to 6 months |
| PrEP Adherence DBS | PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels. | Up to 6 months |
| HIV Incidence | HIV incidence will be tracked in participants through testing up to 6 months. | Up to 6 months |