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PrEP Behavioral Intervention for HIV/AIDS Prevention (PrEP Trial)

N/A

Recruiting

Led By Angela Bazzi, PhD, MPH

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently on and never taken PrEP

Able to understand and speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a behavioral intervention to improve the use of an HIV prevention medication among people who inject drugs.

Who is the study for?

This trial is for people who inject drugs, are at risk for HIV, have never taken PrEP (a medication to prevent HIV), and engage in behaviors like sharing needles or having unprotected sex. Participants must not be on PrEP currently, understand English or Spanish, and plan to stay in Massachusetts for at least a year.

What is being tested?

The study tests 'PrEP for Health,' which includes education about HIV/PrEP, motivational talks, planning help, and patient navigation versus just getting information and referrals. The goal is to see if the program helps participants start and stick with PrEP over time by checking drug levels in their hair.

What are the potential side effects?

Since this trial focuses on behavioral interventions rather than medications directly provided by researchers, side effects are minimal. However, standard side effects of taking PrEP may include nausea, headache, stomach pain, weight loss but these will depend on individual reactions once they begin the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have never taken PrEP.

Select...

I can understand and speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-treatment PrEP adherence

PrEP uptake

Secondary study objectives

Longer-term PrEP adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PrEP for healthExperimental Treatment5 Interventions

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.

Group II: Standard of careActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient navigation

2019

N/A

~1740

Motivational interviewing

2011