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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mental Health Support for Transgender and Gender-expansive Individuals

NCT06229132

Transgender Depression Anxiety +2 more

COMPLETED NA

Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

NCT05323123

Human Immunodeficiency Virus

COMPLETED NA

HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

NCT00310973

HIV Infections

COMPLETED PHASE2/PHASE3

A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk

NCT02929069

HIV Acquired Immunodeficiency Syndrome

COMPLETED NA

International Social Network Intervention

NCT00838773

Behavior

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Comunică

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).

Group Type EXPERIMENTAL

Comunică

Intervention Type 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.

Education Attention Control (EAC)

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.

Group Type ACTIVE_COMPARATOR

Education Attention Control

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

* 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.

Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes