Recruiting

PrEP

Sponsor:

Brown University

Code:

NCT04430257

Conditions

Substance Dependence

HIV (Human Immunodeficiency Virus)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HIV and PrEP education

Motivational interviewing

Problem-solving and planning

Patient navigation

PrEP information

Study Details

Brief summary:

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.

Conditions

Substance Dependence

HIV (Human Immunodeficiency Virus)

Study ID

NCT04430257

Start date

Sep 2, 2021

Status verified date

Apr, 2025

Completion date

May 15, 2026

Anticipated

Primary completion date

May 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

active comparator: Standard of care

Participants in the standard of care arm will receive PrEP information and referrals.

Interventions

HIV and PrEP education

Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.

Motivational interviewing

Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.

Problem-solving and planning

Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.

Patient navigation

Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites

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.

Referrals

Study staff will provide basic information about PrEP and referrals to PrEP clinicians.

Primary outcome measure

  • PrEP uptake [ Time Frame: 3 months ]
  • Post-treatment PrEP adherence [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Katie Biello, PhD, MPH

401-863-6551katie_biello@brown.edu

Angela Bazzi, PhD

abazzi@health.ucsd.edu

Locations

AIDS Action

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Cassidy Ockene

6179276286cockene@fenwayhealth.org

Principal Investigator:

Michelle Bordeu, MPH

Greater Lawrence Family Health Center

Recruiting

Lawrence, Massachusetts, United States, 01841

Contacts

Christopher Bositis, MD

978-689-6444cbositis@glfhc.org

Principal Investigator:

Christopher Bositis, MD

More Information

Sponsor

Brown University

Last update posted

May 4, 2025

Last verified

Apr, 2025

Keywords

  • PrEP (pre-exposure prophylaxis )
  • PWID (people who inject drugs)
  • SSP (syringe service program)
  • HIV education
  • Motivational interviewing
  • Self efficacy
  • Social cognitive theory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2025-05-04.