Study protocol for an efficacy trial of the "PrEP for Health" intervention to increase HIV PrEP use among people who inject drugs.
Angela R Bazzi, Michelle Bordeu, Katrina Baumgartner...
https://pubmed.ncbi.nlm.nih.gov/36932369Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04430257
Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs in Massachusetts
Led by Brown University · Updated on 2025-05-04
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of the "PrEP for Health" behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among people who inject drugs (PWID) at risk of HIV infection. The trial involves 200 PWID recruited from two syringe service program (SSP) sites in Lawrence and Boston/Cambridge, Massachusetts. Researchers will compare this intervention with standard care to see if it increases PrEP uptake and adherence over time. Participants are randomly assigned to one of two groups: the "PrEP for Health" intervention group or the standard of care group. The intervention group receives theory-based HIV and PrEP education, motivational interviewing, problem-solving and planning support, and ongoing patient navigation for three months. The standard care group receives PrEP information via a brief video and referrals to PrEP clinicians. Assessments occur at baseline and at 1, 3, 6, and 12 months after randomization. Participants will complete four follow-up visits during the 12-month study period, including rapid HIV testing at 12 months. Those who start PrEP will provide hair samples at 3, 6, and 12 months to measure adherence through drug levels. Researchers will evaluate PrEP uptake at 3 months and adherence at 3, 6, and 12 months. The study also examines how intervention effects vary by participant characteristics and monitors participant engagement through counseling and navigation support.
CONDITIONS
Brief Title
Pre-exposure Prophylaxis (PrEP) for Health
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- HIV-uninfected as confirmed by rapid or 4th generation test
- Reported injection of any drugs in the past month
- Engaged in at least one HIV risk behavior in the past month (receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)
- Have never taken PrEP and are not currently on PrEP
- Able to understand and speak English or Spanish
You will not qualify if you...
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at enrollment
- Living in Massachusetts for less than 3 months
- Planning to move out of Massachusetts within one year
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive either the PrEP for Health behavioral intervention involving HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation support, or standard of care including PrEP information and referrals.
Baseline visit and 3-month follow-up visit
Follow-up
Duration - 9 months
Participants are assessed for longer-term PrEP adherence and receive rapid HIV screening at 12 months.
Visits at 6 and 12 months after randomization
Trial Site Locations
Total: 2 locations
1
AIDS Action
Cambridge, Massachusetts, United States, 02139
Actively Recruiting
2
Greater Lawrence Family Health Center
Lawrence, Massachusetts, United States, 01841
Actively Recruiting
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Research Team
K
Katie Biello, PhD, MPH
A
Angela Bazzi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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