HIV
Conditions
Brief 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. * 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.
Interventions
OTHEREPIC-P
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).
Sponsors
Gilead Sciences
University of Connecticut
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | Up to 6 months | To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Up to 6 months | 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. |
| PrEP Adherence VAS | Up to 6 months | Adherence to PrEP will be assessed using a visual analog scale (VAS). |
| PrEP Adherence Pharmacy | Up to 6 months | Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants. |
| PrEP Adherence DBS | Up to 6 months | PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels. |
| HIV Incidence | Up to 6 months | HIV incidence will be tracked in participants through testing up to 6 months. |
Countries
United States
Outcome results
None listed