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Integrated PrEP Interventions for HIV Prevention

N/A

Waitlist Available

Research Sponsored by Hilary L Surratt, PhD

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-baseline

Awards & highlights

Study Summary

This trial is testing an evidence-based strengths-based case management intervention for pre-exposure prophylaxis initiation, comparing it to the CDC-PrEP intervention.

Who is the study for?

This trial is for HIV-negative adults over 18 who use syringe service programs in rural Kentucky and have injected drugs in the past month. It's not open to individuals who are already HIV-positive.Check my eligibility

What is being tested?

The study is testing two different ways to help prevent HIV: one using a strengths-based case management approach (SBCM-PrEP) and another based on CDC guidelines (CDC-PrEP). Participants will be randomly assigned to one of these methods.See study design

What are the potential side effects?

While specific side effects are not detailed, PrEP medications can sometimes cause nausea, headaches, stomach pain, and weight loss. Side effects often decrease over time.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-baseline

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

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants initiating PrEP

Secondary outcome measures

Level of Intervention Engagement assessed by session checklist

Level of Intervention Satisfaction assessed by the IAQ

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SBCM-PrEPExperimental Treatment1 Intervention

Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting

Group II: CDC-PrEPActive Control1 Intervention

1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hilary L Surratt, PhDLead Sponsor

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,513 Total Patients Enrolled

Media Library

CDC-PrEP Clinical Trial Eligibility Overview. Trial Name: NCT05037513 — N/A

HIV Prevention Research Study Groups: CDC-PrEP, SBCM-PrEP

HIV Prevention Clinical Trial 2023: CDC-PrEP Highlights & Side Effects. Trial Name: NCT05037513 — N/A

CDC-PrEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05037513 — N/A

Frequently Asked Questions

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

Are there still vacancies for volunteers in this clinical trial?

"Per the information hosted on clinicaltrials.gov, this research initiative is not currently accepting candidates; it was posted initially in September 2021 and last updated in October 2022. Despite its closure to new enrolment, there are 24 other trials that still retain open enrollment opportunities."

Answered by AI

To whom is this research opportunity available?

"This clinical trial is recruiting 80 candidates that meet the following qualifications: HIV positive, within ages 18 to 99 years old, and have a history of prevention."

Answered by AI

Are elderly individuals included in the parameters of this experiment?

"This trial is open to any patient aged 18-99, but there are additional studies specifically for minors and individuals over the age of 65. Specifically, 5 trials cater to those under 18 years old while 16 research projects are tailored towards seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Hilary L Surratt, PhD 2021. "Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05037513.