Pre-exposure Prophylaxis (PrEP) for Health

Study Overview
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Brief Summary
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This randomized controlled trial will test the efficacy of PrEP for Health, a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the PrEP for Health intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.

Detailed Description
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The overall goal of this proposal is to evaluate the efficacy of the PrEP for Health navigator delivered behavioral intervention in improving PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) among PWID in SSPs. Eligible PWID (n=200 total; 100 recruited from each study site) will be equally randomized to an active PrEP for Health intervention arm (n=100) or a Standard of Care control condition (n=100). Assessments will be conducted at baseline and 1, 3, 6, and 12 months after randomization. We hypothesize that brief, multi-component behavioral intervention sessions with ongoing support delivered by trained PrEP Navigators within Syringe Service Programs (SSPs) will improve PrEP uptake, adherence, and long-term adherence in PWID by increasing HIV and PrEP knowledge (including alleviating concerns about side effects), increasing HIV risk perceptions and PrEP interest and motivation, improving PrEP use self-efficacy and behavioral skills, and reducing structural barriers over time. Based on our formative research, we also hypothesize that the strength of intervention effects may differ by key individual characteristics (age, gender, baseline sexual risk, polysubstance, and stimulant use). This is a randomized control trial (RCT). Participants will be recruited via outreach specialist at SSP sites and during routine community outreach practices of the organizations. After eligibility confirmation and baseline assessments, participants will be randomized to one of two study arms: 1) Standard of Care (SOC) Control Condition: as routinely provided through the SSP study sites, participants will receive information and services according to routine practice and a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission; 2) PrEP for Health Intervention Condition: a trained PrEP Navigator will deliver a manualized PrEP uptake and adherence intervention in private counseling rooms at SSPs followed by 3 months of additional PrEP navigation support through in-person, phone, and text interactions as needed. Participants will complete a total of four follow-up visits over a 12-month period. Participants who initiate PrEP will have a hair sample collected at 3-, 6-, and 12-month visits. All participants will receive a rapid HIV screening test at 12-month follow-up.

Official Title
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Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast

Conditions
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Substance Dependence, HIV (Human Immunodeficiency Virus)

Intervention / Treatment
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* Other: HIV and PrEP education
* Behavioral: Motivational interviewing
* Behavioral: Problem-solving and planning
* Behavioral: Patient navigation
* Other: PrEP information
* Other: Referrals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-uninfected (verified by rapid/4th generation test) Reporting past-month injection of any drugs One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner) Not currently on and never taken PrEP Able to understand and speak English or Spanish Exclusion Criteria: Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment Living in Massachusetts (MA) for <3 months Planning to move out of MA within a year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP for health<br>Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation. | Other: HIV and PrEP education<br>* Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.<br>Behavioral: Motivational interviewing<br>* Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.<br>Behavioral: Problem-solving and planning<br>* Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.<br>Behavioral: Patient navigation<br>* Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites<br>Other: PrEP information<br>* A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.<br>|
| Active Comparator: Standard of care<br>Participants in the standard of care arm will receive PrEP information and referrals. | Other: PrEP information<br>* A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.<br>Other: Referrals<br>* Study staff will provide basic information about PrEP and referrals to PrEP clinicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP uptake | PrEP uptake will be assessed via medical/pharmacy records | 3 months | 
| Post-treatment PrEP adherence | PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longer-term PrEP adherence | Longer-term PrEP adherence will be assessed by drug levels in hair samples at 6 and 12-month post-baseline | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP (pre-exposure prophylaxis ), PWID (people who inject drugs), SSP (syringe service program), HIV education, Motivational interviewing, Self efficacy, Social cognitive theory