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Antiretroviral

PrEP for HIV Prevention

N/A

Recruiting

Led By Corina Lelutiu-Weinberger, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

age ≥ 18;

male sex at birth and current male identity;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 3- and 6-month follow-ups

Awards & highlights

Study Summary

This trial aims to establish a program to introduce pre-exposure prophylaxis (PrEP) for HIV prevention in Romania. The program will be tailored to the cultural context and aim to empower gay and bisexual men to adopt and adhere to PrEP. Findings from the trial could inform similar programs in other countries in Central-Eastern Europe.

Who is the study for?

This trial is for gay and bisexual men in Central-Eastern Europe, at least 18 years old, who've had unprotected sex with an HIV-positive or unknown status partner or had a sexually transmitted infection recently. They must want to start PrEP, be HIV-negative, own a mobile device (with support for phone plans if needed), and identify as male both at birth and currently.Check my eligibility

What is being tested?

The study tests 'PrEP Romania', which combines in-person visits with mobile health technology to help these men start and stick to PrEP—a medication that prevents HIV. The program's success could guide similar efforts across Central-Eastern Europe.See study design

What are the potential side effects?

While the description doesn't specify side effects of PrEP directly, common ones include nausea, headaches, stomach pain, weight loss; however most are temporary and often resolve over time.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I was born male and currently identify as male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 3- and 6-month follow-ups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 3- and 6-month follow-ups

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 3- and 6-month follow-ups for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

PrEP Adherence via biological measures

Secondary outcome measures

Anxiety

Depression

HIV risk

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Participants will receive PrEP

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,114 Total Patients Enrolled

Fogarty International Center of the National Institute of HealthNIH

127 Previous Clinical Trials

162,673 Total Patients Enrolled

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,087 Total Patients Enrolled

Media Library

PrEP Romania (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT05323123 — N/A

HIV/AIDS Research Study Groups: Intervention

HIV/AIDS Clinical Trial 2023: PrEP Romania Highlights & Side Effects. Trial Name: NCT05323123 — N/A

PrEP Romania (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05323123 — N/A

Frequently Asked Questions

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

Are enrollees being accepted at this point in the clinical trial?

"According to the information on clinicaltrials.gov, this medical trial is not actively recruiting patients at present. Initially posted in November of 2021, with its most recent update occurring a few months ago in May 2022; while patient recruitment has concluded for now, there are still 83 other studies searching for participants right now."

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