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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

PrEP Trial 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.Check my eligibility

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.See study design

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.

PrEP Trial 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.

PrEP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-treatment PrEP adherence

PrEP uptake

Secondary outcome measures

Longer-term PrEP adherence

PrEP 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

Completed Phase 3

~7250

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER

1,121 Previous Clinical Trials

1,520,724 Total Patients Enrolled

AIDS Action Committee of MassachusettsOTHER

1 Previous Clinical Trials

574 Total Patients Enrolled

Greater Lawrence Family Health CenterUNKNOWN

Media Library

PrEP for Health Clinical Trial Eligibility Overview. Trial Name: NCT04430257 — N/A

HIV/AIDS Research Study Groups: PrEP for health, Standard of care

HIV/AIDS Clinical Trial 2023: PrEP for Health Highlights & Side Effects. Trial Name: NCT04430257 — N/A

PrEP for Health 2023 Treatment Timeline for Medical Study. Trial Name: NCT04430257 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov data confirms that this medical examination is actively recruiting for participants, with an initial posting on September 2nd 2021 and a recent update on May 20th 2022. The trial requires 200 individuals to be recruited from two separate sites."

Answered by AI

Is enrollment open to new participants in this clinical trial?

"Verified by clinicaltrials.gov, this medical trial is still recruiting individuals to participate. Initially posted on September 2nd 2021 and recently edited on May 20th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-exposure Prophylaxis (PrEP) for Health

2021. "Pre-exposure Prophylaxis (PrEP) for Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430257.

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