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

NCT03912753 | Completed Results DMC

• 2 other identifiers: AAAU2518R01MH116829
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; Syphilis; Chlamydia; Gonorrhea

Outcome Measures

Primary Outcomes (2)

• Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days

  Timeline Followback for Online Use (TLFB), which assesses sexual behavior (condomless anal sex acts) in the past month. It collects retrospective day-level data and has been validated for online self-administration.

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

• Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days

  The Timeline Followback for Online Use (TLFB) tool will also ask participants to report occasions of heavy alcohol use (5 or more drinks) alone, and before/during sex, in the previous 30 days.

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

Secondary Outcomes (3)

• Score on Alcohol Use Disorders Identification Test (AUDIT-C)

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

• Score on Center for Epidemiologic Studies Depression Scale (CES-D)

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

• Score on Beck's Anxiety Inventory (BAI)

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

Other Outcomes (23)

• Score on HIV Knowledge Questionnaire

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

• Score on Alcohol Effects Questionnaire

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

• SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore

  Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline

Study Arms (2)

Comunică

EXPERIMENTAL

Comunică is delivered over eight 60-min live chat sessions, delivered by trained psychologists, on our mHealth study platform compatible with any mobile device (laptops, smartphones).

Behavioral: Comunică

Education Attention Control (EAC)

ACTIVE COMPARATOR

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.Topics include 1) GBM identity, 2) "HIV 101," 3) HIV/STI testing, 4) alcohol and the body, 5) the role of alcohol in HIV risk, 6) HIV-status disclosure and sexual health communication, 7) finding social supports, and 8) summary. EAC participants will receive five quiz questions after each module, with correct answers in a following screen.

Other: Education Attention Control

Interventions

Comunică BEHAVIORAL

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.

Comunică

Education Attention Control OTHER

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.

Education Attention Control (EAC)

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Biological males at birth who currently identify as male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gay and bisexual men (GMB) will be eligible if they report:
• Male sex at birth and current male identity;
• At least 16 years old;
• ≥ 1 act of condomless anal sex with an HIV-positive or status-unknown male partner in the prior month;
• ≥ 2 heavy drinking days in the prior month;
• Own a mobile device (smartphone, tablet, laptop); and
• Are confirmed to be HIV-negative upon testing at study baseline.

You may not qualify if:

• GMB will be excluded if they report past-year: a) psychiatric hospitalization; b) psychotic and manic symptoms; or c) current mood-stabilizing or anti-psychotic medication prescription
• Any condition that, in the principal investigators' judgment, interferes with safe study participation.

Sponsors & Collaborators

• Columbia University: lead
• Yale University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Romanian Association against AIDS (ARAS)

Bucharest, Ilfov, Romania

Location

Related Publications (2)

• Lelutiu-Weinberger C, Filimon ML, Hoover D, Lixandru M, Hanu L, Dogaru B, Kovacs T, Fierbinteanu C, Ionescu F, Manu M, Maris A, Pana E, Dorobantescu C, Streinu-Cercel A, Pachankis JE. An mHealth Intervention for Gay and Bisexual Men's Mental, Behavioral, and Sexual Health in a High-Stigma, Low-Resource Context (Project Comunica): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 6;13:e52853. doi: 10.2196/52853.

  PMID: 38709550 DERIVED

• Lelutiu-Weinberger C, Filimon M, Hoover D, Lixandru M, Hanu L, Dogaru B, Kovaks T, Fierbinteanu C, Ionescu F, Manu M, Maris A, Pana E, Dorobantescu C, Streinu-Cercel A, Pachankis J. A randomized controlled trial of an mHealth intervention for gay and bisexual men's mental, behavioral, and sexual health in a high-stigma, low-resource context: Project Comunica protocol. Res Sq [Preprint]. 2023 Jun 26:rs.3.rs-3008174. doi: 10.21203/rs.3.rs-3008174/v1.

  PMID: 37461458 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Risk Reduction Behavior; Alcoholism; Depression; Anxiety Disorders; Sexual Behavior; Syphilis; Chlamydia Infections; Gonorrhea

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; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections; Neisseriaceae Infections

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

• John E. Pachankis, PhD

  Yale 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)

Model Details: The investigators will recruit, screen, assess, and randomize gay and bisexual men at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163).

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 11, 2019
• Study Start: May 20, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Locations

RO (1)