Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

NCT05323123 | Completed Results DMC

• 2 other identifiers: AAAU16735R33TW011752
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 3

Brief Summary

To stem increasing rates of HIV among gay and bisexual men in Central-Eastern Europe, the feasibility, acceptability, and early efficacy of a culturally adapted evidence-based program to introduce pre-exposure prophylaxis (PrEP) into Romania's healthcare practice will be established. PrEP Romania, a hybrid in-person + mHealth PrEP uptake and adherence program, aims to empower gay and bisexual men and their healthcare system to adopt PrEP and support adherence. Findings can inform evidence-based PrEP rollout in other Central-Eastern European countries with similar levels of unpreparedness for biomedical prevention.

Conditions

Human Immunodeficiency Virus

Keywords

pre-exposure prophylaxis; gay and bisexual men

Outcome Measures

Primary Outcomes (1)

• PrEP Adherence Via Biological Measures (Binary)

  A binary measure of blood plasma concentration of tenofovir diphosphate (TFVdp) from PrEP medication determined using via dried blood spot or DBS analysis. ≥4 doses per week, equivalent to ≥1,000 fmol TFVdp has been shown to be protective against HIV transmission. A measurement of ≥1,000 fmol TFVdp therefore demonstrates sufficient PrEP adherence (i.e., a better outcome).

  Measured at 3 months post-baseline and 6 months post-baseline

Secondary Outcomes (14)

• PrEP Adherence Via Biological Measures (Continuous)

  Measured at 3 months post-baseline and 6 months post-baseline

• PrEP Adherence Via Self-report Measures (Binary)

  Measured at 3 months post-baseline and 6 months post-baseline.

• PrEP Adherence Via Self-report Measures (Continuous)

  Measured at 3 months post-baseline and 6 months post-baseline.

• PrEP Motivation

  Measured at baseline, 3 months post-baseline, and 6 months post-baseline

• PrEP Knowledge

  Measured at baseline, 3 months post-baseline, and 6 months post-baseline

Study Arms (2)

PrEP Romania

EXPERIMENTAL

Participants will receive PrEP (as part of their standard of care), motivational counseling, and PrEP adherence support.

Behavioral: SPARK; Behavioral: HealthMpowerment

Control

ACTIVE COMPARATOR

Participants will receive PrEP (as part of their standard of care) and PrEP education during medical visits.

Behavioral: PrEP Education

Interventions

SPARK BEHAVIORAL

SPARK is delivered in a clinic setting by a counselor using motivational interviewing techniques (e.g., open-ended questions, affirmations).

Also known as: Sexual Health Counseling

PrEP Romania

HealthMpowerment BEHAVIORAL

PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling.

PrEP Romania

PrEP Education BEHAVIORAL

Educational information about PrEP provided by physician during medical visits.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• those not meeting eligibility

Sponsors & Collaborators

• Columbia University: lead
• Yale University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

Columbia University School of Nursing

New York, New York, 10032, United States

Location

Romanian Association Against AIDS

Bucharest, Romania

Location

Romanian Association Against AIDS

Cluj-Napoca, Romania

Location

Related Publications (1)

• Lelutiu-Weinberger C, Filimon ML, Zavodszky AM, Lixandru M, Hanu L, Fierbinteanu C, Patrascu R, Streinu-Cercel A, Luculescu S, Bora M, Filipescu I, Jianu C, Hightow-Weidman LB, Rochelle A, Yi B, Buckner N, Golub SA, van Dyk IS, Burger J, Li F, Pachankis JE. Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men. Trials. 2024 Jul 10;25(1):470. doi: 10.1186/s13063-024-08313-4.

  PMID: 38987812 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Homosexuality

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Results Point of Contact

• Title: Corina Lelutiu-Weinberger, PhD
• Organization: Columbia University

cl4265@cumc.columbia.edu

(212) 342-1502

Study Officials

• Corina Lelutiu-Weinberger, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Sciences Research (in Nursing)

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 12, 2022
• Study Start: October 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); RO (2)