Pre-exposure Prophylaxis (PrEP) for Health

NCT04430257 | Recruiting DMC

• 2 other identifiers: 2011002841R01DA051849-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Longer-term PrEP adherence

  6 and 12 months

Study Arms (2)

PrEP for health

EXPERIMENTAL

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; Behavioral: Motivational interviewing; Behavioral: Problem-solving and planning; Behavioral: Patient navigation; Other: PrEP information

Standard of care

ACTIVE COMPARATOR

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

Other: PrEP information; Other: Referrals

Interventions

HIV and PrEP education OTHER

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

PrEP for health

Motivational interviewing BEHAVIORAL

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

PrEP for health

Problem-solving and planning BEHAVIORAL

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

PrEP for health

Patient navigation BEHAVIORAL

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

PrEP for health

PrEP information OTHER

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.

PrEP for health; Standard of care

Referrals OTHER

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

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The Fenway Institute: collaborator
• AIDS Action Committee of Massachusetts: collaborator
• Greater Lawrence Family Health Center: collaborator
• University of California, San Diego: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

AIDS Action

Cambridge, Massachusetts, 02139, United States

RECRUITING

Greater Lawrence Family Health Center

Lawrence, Massachusetts, 01841, United States

RECRUITING

Related Publications (1)

• Bazzi AR, Bordeu M, Baumgartner K, Sproesser DM, Bositis CM, Krakower DS, Mimiaga MJ, Biello KB. Study protocol for an efficacy trial of the "PrEP for Health" intervention to increase HIV PrEP use among people who inject drugs. BMC Public Health. 2023 Mar 17;23(1):513. doi: 10.1186/s12889-023-15429-w.

  PMID: 36932369 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome

Interventions

Seroconversion; Motivational Interviewing; Patient Navigation; Referral and Consultation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Professional Practice; Organization and Administration

Study Officials

• Katie Biello, PhD, MPH

  Brown University

  PRINCIPAL INVESTIGATOR

• Angela Bazzi, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Biello, PhD, MPH

CONTACT

401-863-6551; katie_biello@brown.edu

Angela Bazzi, PhD

CONTACT

abazzi@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals collecting the primary outcome data will be blinded to intervention condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: September 2, 2021
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after the study has closed and after publication of the primary study findings.
• Access Criteria: Requests will be reviewed by the principal investigators.

Locations

US (2)