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New program aims to boost HIV prevention pill use in eastern europe

NCT ID NCT05323123

Prevention Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a program to help gay and bisexual men in Romania begin and continue taking PrEP, a daily pill that prevents HIV. The program combined in-person counseling, an educational app, and support from doctors. Researchers wanted to see if this approach was practical and effective in a region where PrEP is not widely used.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PrEP (pre-exposure prophylaxis) medication
What this could lead to
If successful, this program could help more men in Central-Eastern Europe access and use PrEP, reducing new HIV infections in the region.
What could go wrong
This was a small, early feasibility study (120 participants) in one country, so results may not apply broadly. The program's success depends on real-world healthcare systems and individual adherence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Men will be eligible based on CDC criteria for GBM PrEP candidates, as European guidelines are yet to be formalized: * male sex at birth and current male identity; * age ≥ 18; * ≥1 acts of condomless anal sex with an HIV-positive or status-unknown male partner or diagnosis of bacterial sexually transmitted infection in past 6 months; * intentions to start a PrEP regimen; * confirmed to be HIV-negative upon study testing; and * own a mobile device (smartphone, tablet, laptop); this is highly feasible given the high prevalence of smartphone and internet use in Romania, but we will cover phone plans if needed. Exclusion Criteria: • those not meeting eligibility

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Conditions

The condition(s) this trial relates to.

AIDS Homosexuality HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human immunodeficiency virus

Contacts and locations

Locations

  • Columbia University School of Nursing

    New York, New York, 10032, United States

  • Romanian Association Against AIDS

    Bucharest, Romania

  • Romanian Association Against AIDS

    Cluj-Napoca, Romania

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