Human Immunodeficiency VirusNCT03912753
Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
A study testing Comunică in people with Human Immunodeficiency Virus and Risk Reduction, run by Columbia University at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Risk Reduction, Alcohol Abuse
- What is being tested?
- Comunică
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteRomania
- Study dates
- 20 May 2019to 31 Jan 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This project is designed to remedy unaddressed and interlocking HIV-prevention and mental health needs among gay and bisexual men (GBM) in the Central Eastern European country of Romania, and their underpinning stigma-related mechanisms. Rampant stigma contributes to the increasing prevalence of HIV among Romanian GBM (from under 10% in 2009 to close to 20% in 2014, by best available estimates) and keeps GBM out-of-reach of HIV-prevention services. An mHealth pilot intervention (titled "Despre Mine. Despre Noi." (DMDN) translated as "About Me. About Us."), which reduced Romanian GBM's risk for HIV infection while also reducing depression and alcohol abuse in an initial pre-post trial, is now ready for testing in a randomized controlled trial with a large national sample in the current study, entitled Comunică (translation: Communicate).
The Comunică intervention entails eight 60-minute live chat sessions delivered by trained counselors on a mobile study platform using motivational interviewing (MI) and cognitive-behavioral skills training (CBST). First, during pre-trial (months 1-5), in collaboration with a community advisory board consisting of GBM community members, GBM-affirmative physical and mental health providers, and a technical developer, the investigators will fine-tune the Comunică intervention based on the investigators' pilot findings and evaluation interviews, and expand the original DMDN education materials for an education attention condition (EAC) that will serve as control. Second, during the intervention phase (mos 6-45), the investigators will recruit, screen, assess, and randomize GBM at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163). The conditions are content matched, and both are hosted on the study platform. While Comunică will consist of eight weekly mHealth live chat sessions, EAC will consist of eight self-administered educational modules. Third, during the follow-up phase (mos 8-55), the investigators will assess at 4, 8, and 12 months post-baseline, in a mobile fashion identical to the baseline, the primary outcome of condomless anal sex with male partners and secondary outcomes of alcohol abuse, depression, biologic HIV/STI infection, HIV/STI testing, and psychosocial mechanisms rooted in the Information-Motivation-Behavioral Skills (IMB) model (e.g., HIV/STI knowledge, condom use self-efficacy) and minority stress theory (e.g., identity concealment, internalized homophobia).
- Conditions
- Human Immunodeficiency Virus, Risk Reduction, Alcohol Abuse, Depression, Anxiety, Behavior, Sex
- Being tested
- Comunică, Education Attention Control
- Keywords
- HIV, Syphilis, Chlamydia, Gonorrhea
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Risk Reduction Behavior, Alcoholism, Depression, Anxiety Disorders, Sexual Behavior, Syphilis, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComunicăBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Education Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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)
The Alcohol Use Disorders Identification Test (AUDIT-C) is a 3-item screening tool use to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Participants will report on standard drinks. The total score range is 0 to 12 (each item is scored 0-4), where an overall score of 4 or more is considered to indicate hazardous or harmful alcohol use. Higher scores indicate more hazardous/harmful alcohol use (i.e., a worse outcome).
Measured: 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)
Center for Epidemiologic Studies Depression Scale (CES-D) is a self-report, standardized measure for depressive symptoms. It consists of 20 items in which respondents rate how frequently each item applied to them over the course of the past week. Ratings for each item are based on a 4-point Likert scale ranging from 0="rarely or none of the time (less than 1 day)" to 3="most or all of the time (5-7 days)". Item scores are summed to obtain an overall score from 0 to 60, where higher scores mean more depressive symptoms (i.e., a worse outcome).
Measured: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
Score on Beck's Anxiety Inventory (BAI)
Beck's Anxiety Inventory (BAI) is a brief self-report measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It consists of 21 items and respondents indicate how much they have been bothered by each symptom over the past week. Responses to each item are rated on a 4-point Likert scale and range from 0="not at all" to 3="severely". Item scores are summed to obtain an overall score from 0 to 63, where higher scores indicate more anxiety symptoms (i.e., worse outcome).
Measured: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start20 May 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Corina Lelutiu-Weinberger, Columbia University
- Investigators
- Corina Lelutiu-Weinberger, PhD, Principal investigator, Columbia UniversityJohn E. Pachankis, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912753
- Sponsor's protocol ID
- AAAU2518
- Other IDs
- R01MH116829
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2019
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lelutiu-Weinberger C, L Filimon M, Zavodszky AM, Hoover DR, Scheinmann R, Lixandru M, Hanu L, Dogaru B, Scheer JR, van Dyk IS, Dorobantescu C, Streinu-Cercel A, Pachankis JE. A Mobile Counseling Program for Gay and Bisexual Men's Mental, Behavioral, and Sexual Health in Eastern Europe: A Randomized Controlled Trial. AIDS Behav. 2026 Aug 14. doi: 10.1007/s10461-026-05274-4. Online ahead of print.
PubMed 42599370Lelutiu-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.
PubMed 38709550Lelutiu-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.
PubMed 37461458