Pre-exposure Prophylaxis (PrEP) for Health

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Brown University
Study ID
NCT04430257
Status
Recruiting
Apply to this trial

Conditions

  • HIV (Human Immunodeficiency Virus)
  • Substance Dependence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HIV and PrEP education — OTHER
    Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.
  • Motivational interviewing — BEHAVIORAL
    Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.
  • Problem-solving and planning — BEHAVIORAL
    Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.
  • Patient navigation — BEHAVIORAL
    Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites
  • 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.
  • Referrals — OTHER
    Study staff will provide basic information about PrEP and referrals to PrEP clinicians.

Study Details

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.

Key Dates

Start date
Sep 2, 2021
Status verified
Apr 2025
Primary completion
May 15, 2026
Completion
May 15, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

PrEP uptake [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
AIDS ActionCambridgeMassachusetts02139
Cassidy Ockene
[email protected]
6179276286
Michelle Bordeu, MPH (PRINCIPAL_INVESTIGATOR)
Greater Lawrence Family Health CenterLawrenceMassachusetts01841
Christopher Bositis, MD
[email protected]
978-689-6444
Christopher Bositis, MD (PRINCIPAL_INVESTIGATOR)
Katrina Baumgartner, MD (PRINCIPAL_INVESTIGATOR)

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