16 and older, male only, with Human Immunodeficiency Virus or Risk Reduction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 DaysPrimary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
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.
Baseline
Group
Value
95% CI
Comunică
5.03
± 5.47
Education Attention Control (EAC)
6.40
± 8.33
4 months
Group
Value
95% CI
Comunică
3.14
± 7.01
Education Attention Control (EAC)
2.37
± 5.02
8 months
Group
Value
95% CI
Comunică
3.35
± 6.58
Education Attention Control (EAC)
2.60
± 6.72
12 months
Group
Value
95% CI
Comunică
2.35
± 4.65
Education Attention Control (EAC)
3.15
± 7.43
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 DaysPrimary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
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.
Baseline
Group
Value
95% CI
Comunică
5.74
± 4.98
Education Attention Control (EAC)
5.32
± 4.39
4 months
Group
Value
95% CI
Comunică
3.85
± 3.84
Education Attention Control (EAC)
3.06
± 4.01
8 months
Group
Value
95% CI
Comunică
3.25
± 3.81
Education Attention Control (EAC)
2.80
± 4.23
12 months
Group
Value
95% CI
Comunică
2.78
± 3.68
Education Attention Control (EAC)
2.48
± 3.90
Score on Alcohol Use Disorders Identification Test (AUDIT-C)Secondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
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).
Baseline
Group
Value
95% CI
Comunică
5.14
± 2.07
Education Attention Control (EAC)
5.10
± 2.03
4 months
Group
Value
95% CI
Comunică
4.24
± 2.00
Education Attention Control (EAC)
4.20
± 2.14
8 months
Group
Value
95% CI
Comunică
4.05
± 2.03
Education Attention Control (EAC)
3.86
± 1.99
12 months
Group
Value
95% CI
Comunică
3.94
± 2.06
Education Attention Control (EAC)
3.75
± 1.88
Score on Center for Epidemiologic Studies Depression Scale (CES-D)Secondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
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).
Baseline
Group
Value
95% CI
Comunică
22.06
± 10.91
Education Attention Control (EAC)
21.44
± 13.83
4 months
Group
Value
95% CI
Comunică
17.30
± 10.32
Education Attention Control (EAC)
18.66
± 11.96
8 months
Group
Value
95% CI
Comunică
17.80
± 12.50
Education Attention Control (EAC)
17.90
± 12.25
12 months
Group
Value
95% CI
Comunică
16.82
± 12.02
Education Attention Control (EAC)
16.64
± 11.83
Score on Beck's Anxiety Inventory (BAI)Secondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
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).
Baseline
Group
Value
95% CI
Comunică
15.20
± 9.80
Education Attention Control (EAC)
15.64
± 10.04
4 months
Group
Value
95% CI
Comunică
10.73
± 8.93
Education Attention Control (EAC)
11.64
± 9.69
8 months
Group
Value
95% CI
Comunică
9.55
± 9.53
Education Attention Control (EAC)
11.02
± 10.51
12 months
Group
Value
95% CI
Comunică
9.98
± 9.91
Education Attention Control (EAC)
9.94
± 9.98
Score on HIV Knowledge QuestionnaireSecondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
The HIV Knowledge Questionnaire is a 13-item, brief self-report measure of HIV-related knowledge. Respondents read each statement about HIV and indicate whether they think the statement is true or false, or they indicate that they "don't know." Responses are scored 0 (incorrect or unsure) or 1 (correct), and results are summed to obtain the number of statements correctly identified as true or false. The total score ranges from 0 to 13, where a higher score indicates more correct responses (i.e., better outcome).
Baseline
Group
Value
95% CI
Comunică
10.34
± 1.96
Education Attention Control (EAC)
10.50
± 2.39
4 months
Group
Value
95% CI
Comunică
11.29
± 1.57
Education Attention Control (EAC)
11.83
± 1.58
8 months
Group
Value
95% CI
Comunică
11.47
± 1.87
Education Attention Control (EAC)
11.78
± 1.73
12 months
Group
Value
95% CI
Comunică
11.59
± 1.51
Education Attention Control (EAC)
12.06
± 1.24
Score on Alcohol Effects QuestionnaireSecondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
Alcohol-related knowledge was measured through an 8-item version of a questionnaire featuring 8 true/false statements about alcohol (e.g., "A person cannot become an alcoholic by just drinking beer"). Responses were scored as either 0 (incorrect answer or "I don't know") or 1 (correct answer) and summed to obtain a final score from 0 to 8, where a higher score indicates a more correct responses (i.e., a better outcome).
Baseline
Group
Value
95% CI
Comunică
5.60
± 1.40
Education Attention Control (EAC)
5.60
± 1.24
4 months
Group
Value
95% CI
Comunică
5.66
± 1.45
Education Attention Control (EAC)
6.05
± 1.28
8 months
Group
Value
95% CI
Comunică
5.62
± 1.58
Education Attention Control (EAC)
5.94
± 1.61
12 months
Group
Value
95% CI
Comunică
5.60
± 1.63
Education Attention Control (EAC)
6.37
± 1.39
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition SubscoreSecondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
The SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) is a 19-item, self-administered instrument designed to assess client motivation to change drinking-related behavior. It is made up of three subscales: Problem Recognition (score range 7 to 35), Ambivalence (score range is 4 to 20), and Taking Steps (score range is 8 to 40). Respondents rate their agreement with each item on a 5-point Likert-type scale (from 1=strongly disagree to 5=strongly agree), and items within each subscale are summed to obtain three subscores. A higher Problem Recognition subscore indicates a higher
Baseline
Group
Value
95% CI
Comunică
13.92
± 6.38
Education Attention Control (EAC)
13.93
± 5.90
4 months
Group
Value
95% CI
Comunică
12.72
± 6.31
Education Attention Control (EAC)
12.68
± 5.69
8 months
Group
Value
95% CI
Comunică
11.58
± 5.77
Education Attention Control (EAC)
12.07
± 6.10
12 months
Group
Value
95% CI
Comunică
11.40
± 6.17
Education Attention Control (EAC)
11.55
± 5.82
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence SubscoreSecondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
The SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) is a 19-item, self-administered instrument designed to assess client motivation to change drinking-related behavior. It is made up of three subscales: Problem Recognition (score range 7 to 35), Ambivalence (score range is 4 to 20), and Taking Steps (score range is 8 to 40). Respondents rate their agreement with each item on a 5-point Likert-type scale (from 1=strongly disagree to 5=strongly agree), and items within each subscale are summed to obtain three subscores. A higher Ambivalence subscore indicates a higher degree o
Baseline
Group
Value
95% CI
Comunică
8.85
± 4.26
Education Attention Control (EAC)
8.91
± 4.05
4 months
Group
Value
95% CI
Comunică
7.88
± 3.99
Education Attention Control (EAC)
7.92
± 4.01
8 months
Group
Value
95% CI
Comunică
7.02
± 3.73
Education Attention Control (EAC)
7.16
± 3.91
12 months
Group
Value
95% CI
Comunică
6.94
± 4.00
Education Attention Control (EAC)
7.25
± 3.94
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps SubscoreSecondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
The SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) is a 19-item, self-administered instrument designed to assess client motivation to change drinking-related behavior. It is made up of three subscales: Problem Recognition (score range 7 to 35), Ambivalence (score range is 4 to 20), and Taking Steps (score range is 8 to 40). Respondents rate their agreement with each item on a 5-point Likert-type scale (from 1=strongly disagree to 5=strongly agree), and items within each subscale are summed to obtain three subscores. A higher Taking Steps subscore indicates the individual i
Baseline
Group
Value
95% CI
Comunică
16.74
± 7.29
Education Attention Control (EAC)
17.57
± 6.90
4 months
Group
Value
95% CI
Comunică
17.96
± 9.20
Education Attention Control (EAC)
18.02
± 8.27
8 months
Group
Value
95% CI
Comunică
16.09
± 8.56
Education Attention Control (EAC)
15.79
± 7.84
12 months
Group
Value
95% CI
Comunică
16.51
± 9.40
Education Attention Control (EAC)
16.34
± 8.63
Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without CondomsSecondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline.
The Decisional Balance Scale assesses perceived benefits of sex with and without condoms. Responses to the 18-item scale assessed the benefits (e.g., "Sex without a condom is more spontaneous") and costs (e.g., "I feel guilty after having sex without a condom") of lack of condom use, yielding two subscales. Each participant was asked to rate how important each benefit and cost statement would be when deciding whether to use a condom for anal sex from 1="not at all important" to 5="extremely important"). Responses for each subscore ("Importance of statements for sex without condoms" and "Import
Baseline
Group
Value
95% CI
Comunică
2.99
± 0.77
Education Attention Control (EAC)
3.00
± 0.67
4 months
Group
Value
95% CI
Comunică
2.49
± 0.82
Education Attention Control (EAC)
2.69
± 0.78
8 months
Group
Value
95% CI
Comunică
2.46
± 0.87
Education Attention Control (EAC)
2.61
± 0.82
12 months
Group
Value
95% CI
Comunică
2.42
± 0.85
Education Attention Control (EAC)
2.59
± 0.80
Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without CondomsSecondary· Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
The Decisional Balance Scale assesses perceived benefits of sex with and without condoms. Responses to the 18-item scale assessed the benefits (e.g., "Sex without a condom is more spontaneous") and costs (e.g., "I feel guilty after having sex without a condom") of lack of condom use, yielding two subscales. Each participant was asked to rate how important each benefit and cost statement would be when deciding whether to use a condom for anal sex from 1="not at all important" to 5="extremely important"). Responses for each subscore ("Importance of statements for sex without condoms" and "Import
Baseline
Group
Value
95% CI
Comunică
3.20
± 0.74
Education Attention Control (EAC)
3.15
± 0.81
4 months
Group
Value
95% CI
Comunică
3.26
± 0.78
Education Attention Control (EAC)
3.27
± 0.75
8 months
Group
Value
95% CI
Comunică
3.23
± 0.80
Education Attention Control (EAC)
3.27
± 0.80
12 months
Group
Value
95% CI
Comunică
3.16
± 0.79
Education Attention Control (EAC)
3.17
± 0.79
Adverse events — posted to ClinicalTrials.gov
Time frame: During an assessment or counseling session, from baseline survey to 12-months post randomization.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03912753.