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

NCT03912753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-15

Study results available
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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.

Conditions

  • Human Immunodeficiency Virus
  • Risk Reduction
  • Alcohol Abuse
  • Depression, Anxiety
  • Behavior, Sex

Interventions

BEHAVIORAL

Comunică

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.

OTHER

Education Attention Control

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.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Columbia University

    lead OTHER

Principal Investigators

  • Corina Lelutiu-Weinberger, PhD · Columbia University

  • John E. Pachankis, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Romania

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03912753 on ClinicalTrials.gov