Trial results for a study investigating mobile HIV prevention and mental health support were posted on ClinicalTrials.gov on 2025-09-15, with 300 participants enrolled.
Background
Human Immunodeficiency Virus (HIV) prevention remains a critical public health challenge, particularly in low-resource settings and among key populations such as gay and bisexual men. Alongside HIV risk, mental health issues like depression and anxiety, and behaviors such as alcohol abuse and certain sexual behaviors, can significantly impact an individual's vulnerability and overall well-being. Innovative, accessible interventions are needed to address these interconnected factors. This study explored the use of mobile technology to deliver support for HIV risk reduction and mental health in such contexts.
Trial design
This completed study, designated as Phase NA, enrolled 300 participants from Romania. The trial focused on conditions including Human Immunodeficiency Virus, Risk Reduction, Alcohol Abuse, Depression, Anxiety, and Behavior, Sex. The research aimed to provide help and support for mental health and HIV risk reduction among Romanian gay and bisexual men using mobile devices. Participants engaged in confidential surveys and 8 confidential one-hour sessions, either with a trained counselor via chat (the "Comunică" group) or by reading health information (the "Education Attention Control (EAC)" group). The study also involved testing for HIV, syphilis, chlamydia, and gonorrhea.
Key results
The trial reported several key measurements related to self-reported condomless anal sex acts and heavy alcohol use:
- Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days:
- For the "Comunică" group, mean values were 5.03 (Standard Deviation 5.47), 3.14 (Standard Deviation 7.01), 3.35 (Standard Deviation 6.58), and 2.35 (Standard Deviation 4.65) condomless anal sex acts.
- For the "Education Attention Control (EAC)" group, mean values were 6.40 (Standard Deviation 8.33), 2.37 (Standard Deviation 5.02), 2.60 (Standard Deviation 6.72), and 3.15 (Standard Deviation 7.43) condomless anal sex acts.
- Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days:
- For the "Comunică" group, mean values were 5.74 (Standard Deviation 4.98) and 3.85 (Standard Deviation 3.84) days with heavy alcohol use.
- For the "Education Attention Control (EAC)" group, mean values were 5.32 (Standard Deviation 4.39) and 3.06 (Standard Deviation 4.01) days with heavy alcohol use.
What this means
The posted results provide detailed measurements on self-reported condomless anal sex acts and days with heavy alcohol use for participants in both the "Comunică" and "Education Attention Control (EAC)" groups. This study explored the feasibility and outcomes of mobile-based interventions for HIV prevention and mental health support among Romanian gay and bisexual men. While specific mean values and standard deviations are reported for these behavioral outcomes, the data as presented does not include comparative analyses or statistical significance between the groups. These measurements contribute to the understanding of behavioral patterns in this population and the potential impact of mobile support strategies, laying groundwork for further research and intervention development.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03912753, titled "Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings", were posted on 2025-09-15 on clinicaltrials.gov.