CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Comunică +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03912753
NCT03912753N/ACompleted

Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings

Columbia University·interventional·Posted Apr 11, 2019·Updated Sep 15, 2025

In Brief

A clinical study evaluating Comunică and Education Attention Control for Human Immunodeficiency Virus and 4 related conditions. Completed, enrolled 300 participants across 1 site.

Detailed Summary

The purpose of this research study is to provide help and support for mental health and human immunodeficiency virus (HIV) risk reduction among Romanian gay and bisexual men. GBM will participate in this study using mobile device (phones, tablets, or laptops) and will complete several confidential surveys and 8 confidential one-hour sessions, either with a trained counselor via chat or by reading about health information. This study also involves testing for HIV, syphilis, chlamydia, and gonorrhea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRomania

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 11, 2019
Enrollment StartMay 20, 2019
Primary CompletionJan 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.2 years ago

Interventions

Comunicăbehavioral

Comunică is based on the Information-Motivation-Behavioral Skills (IMB) model of health behavior change, which postulates that individuals must possess the requisite information for enacting sexual health, motivation to change their HIV risk and alcohol use, and behavioral skills necessary for reducing their risk. Therefore, Comunică includes MI to provide accurate information about HIV transmission, alcohol abuse, and local GBM-affirmative health resources and build motivation to improve behavioral skills (via CBST). CBST is a therapeutic approach used in the treatment of various behavioral problems, such as alcohol abuse and depression and more recently HIV risk. CBST can help modify cognitions driving unhealthy behaviors, promote awareness of contextual triggers and unhealthy behavioral patterns, and teach coping skills to improve health. Comunică also draws upon minority stress theory recognizing that stigmatizing societal contexts compromise health behavior.

Education Attention Controlother

The EAC condition consists of eight self-administered modularized topics, content-matched with the Comunică sessions, which we have generated based on our HIV-prevention education with GBM in the US and Romania.