Pre-exposure Prophylaxis (PrEP) for Health (PrEP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Dependence; HIV (Human Immunodeficiency Virus)
• Intervention / Treatment: Other: HIV and PrEP education; Behavioral: Motivational interviewing; Behavioral: Problem-solving and planning; Behavioral: Patient navigation; Other: PrEP information; Other: Referrals

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Biello, PhD, MPH; Phone Number: 401-863-6551; Email: katie_biello@brown.edu
• Study Contact Backup: Name: Angela Bazzi, PhD; Email: abazzi@health.ucsd.edu

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Recruiting
      • AIDS Action
      • Contact: Cassidy Ockene; Phone Number: 617-927-6286; Email: cockene@fenwayhealth.org
      • Principal Investigator: Michelle Bordeu, MPH
    • Lawrence, Massachusetts, United States, 01841
      • Recruiting
      • Greater Lawrence Family Health Center
      • Contact: Christopher Bositis, MD; Phone Number: 978-689-6444; Email: cbositis@glfhc.org
      • Principal Investigator: Christopher Bositis, MD
      • Principal Investigator: Katrina Baumgartner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PrEP for health; 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; Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.; Behavioral: Motivational interviewing; Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.; Behavioral: Problem-solving and planning; Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.; Behavioral: Patient navigation; Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites; Other: PrEP information; 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.
Active Comparator: Standard of care; Participants in the standard of care arm will receive PrEP information and referrals.	Other: PrEP information; 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.; Other: Referrals; Study staff will provide basic information about PrEP and referrals to PrEP clinicians.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA); University of California, San Diego; Beth Israel Deaconess Medical Center; The Fenway Institute; AIDS Action Committee of Massachusetts; Greater Lawrence Family Health Center
• Investigators: Principal Investigator: Katie Biello, PhD, MPH, Brown University; Principal Investigator: Angela Bazzi, PhD, MPH, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Motivational interviewing; HIV education; Self efficacy; Social cognitive theory; PrEP (pre-exposure prophylaxis ); PWID (people who inject drugs); SSP (syringe service program)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; Substance-Related Disorders; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2011002841; R01DA051849-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: By request to the study investigators
• IPD Sharing Time Frame: Data will be available after the study has closed and after publication of the primary study findings.
• IPD Sharing Access Criteria: Requests will be reviewed by the principal investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No