Improving PrEP use among people who inject drugs
Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast
This study is testing a new program to see if giving more support and education about PrEP can help people who inject drugs use it more and reduce their risk of getting HIV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brown University Academic / other |
| Locations | 2 sites (Cambridge, Massachusetts and 1 other locations) |
| Trial ID | NCT04430257 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the 'PrEP for Health' intervention aimed at increasing the uptake and adherence of pre-exposure prophylaxis (PrEP) among at-risk individuals who inject drugs (PWID) in syringe service programs in Massachusetts. Participants will be randomly assigned to either the intervention group, which receives comprehensive education, motivational interviewing, and ongoing support, or a standard care group that receives basic PrEP information. The study will assess PrEP uptake and adherence through medical records and drug levels in hair at multiple time points over a year. The goal is to identify effective strategies to enhance PrEP use and ultimately reduce HIV transmission among PWID.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-uninfected individuals who inject drugs and exhibit one or more HIV risk behaviors.
Not a fit: Patients who are currently on PrEP or have previously taken PrEP will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly increase PrEP uptake and adherence among at-risk populations, leading to reduced HIV transmission rates.
How similar studies have performed: Previous studies have shown promising results with behavioral interventions aimed at increasing PrEP adherence among high-risk populations, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cambridge, Massachusetts and 1 other locations
- AIDS Action — Cambridge, Massachusetts, United States (Recruiting)
- Greater Lawrence Family Health Center — Lawrence, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Katie Biello, PhD, MPH — Brown University
- Study coordinator: Katie Biello, PhD, MPH
- Email: katie_biello@brown.edu
- Phone: 401-863-6551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.