Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05323123
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SPARK — BEHAVIORAL
    SPARK is delivered in a clinic setting by a counselor using motivational interviewing techniques (e.g., open-ended questions, affirmations).
  • 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 Education — BEHAVIORAL
    Educational information about PrEP provided by physician during medical visits.

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Oct 2025
Primary completion
Sep 30, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PrEP Romania
    Participants will receive PrEP (as part of their standard of care), motivational counseling, and PrEP adherence support.
  • Active Comparator: Control
    Participants will receive PrEP (as part of their standard of care) and PrEP education during medical visits.

Primary Outcome Measure

PrEP Adherence Via Biological Measures (Binary) [ Time Frame: Measured at 3 months post-baseline and 6 months post-baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University School of NursingNew YorkNew York10032-

Find similar trials in New York, NY

By condition
HIV
By specialty
Infectious disease
By research site
Columbia University School of Nursing· New York, NY

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