Pre-exposure Prophylaxis (PrEP) for Health

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)

Interventions

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.

OTHER

Referrals

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• The Fenway Institute

  collaborator OTHER

• AIDS Action Committee of Massachusetts

  collaborator OTHER

• Greater Lawrence Family Health Center

  collaborator UNKNOWN

• University of California, San Diego

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Brown University

  lead OTHER

Principal Investigators

• Katie Biello, PhD, MPH · Brown University

• Angela Bazzi, PhD, MPH · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-02

Primary Completion

2026-05-15

Completion

2026-05-15

Countries

• United States

Study Locations