Trial Outcomes & Findings for Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings (NCT NCT03912753)
NCT ID: NCT03912753
Last Updated: 2025-09-15
Results Overview
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.
COMPLETED
NA
300 participants
Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
2025-09-15
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
151
|
|
Overall Study
COMPLETED
|
149
|
151
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Baseline characteristics by cohort
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.93 years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
25.87 years
STANDARD_DEVIATION 7.38 • n=7 Participants
|
25.40 years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Romanian
|
137 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hungarian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Roma
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
149 participants
n=5 Participants
|
151 participants
n=7 Participants
|
300 participants
n=5 Participants
|
|
Sexual orientation
Gay
|
97 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sexual orientation
Bisexual
|
49 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sexual orientation
Heterosexual
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual orientation
Queer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexual orientation
Pansexual
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexual orientation
Asexual
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual orientation
Demisexual
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual orientation
Uncertain / don't know for sure
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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.
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days
12 months
|
2.35 condomless anal sex acts
Standard Deviation 4.65
|
3.15 condomless anal sex acts
Standard Deviation 7.43
|
|
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days
Baseline
|
5.03 condomless anal sex acts
Standard Deviation 5.47
|
6.40 condomless anal sex acts
Standard Deviation 8.33
|
|
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days
4 months
|
3.14 condomless anal sex acts
Standard Deviation 7.01
|
2.37 condomless anal sex acts
Standard Deviation 5.02
|
|
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days
8 months
|
3.35 condomless anal sex acts
Standard Deviation 6.58
|
2.60 condomless anal sex acts
Standard Deviation 6.72
|
PRIMARY outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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.
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days
Baseline
|
5.74 days with heavy alcohol use
Standard Deviation 4.98
|
5.32 days with heavy alcohol use
Standard Deviation 4.39
|
|
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days
4 months
|
3.85 days with heavy alcohol use
Standard Deviation 3.84
|
3.06 days with heavy alcohol use
Standard Deviation 4.01
|
|
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days
8 months
|
3.25 days with heavy alcohol use
Standard Deviation 3.81
|
2.80 days with heavy alcohol use
Standard Deviation 4.23
|
|
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days
12 months
|
2.78 days with heavy alcohol use
Standard Deviation 3.68
|
2.48 days with heavy alcohol use
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on Alcohol Use Disorders Identification Test (AUDIT-C)
Baseline
|
5.14 score on a scale
Standard Deviation 2.07
|
5.10 score on a scale
Standard Deviation 2.03
|
|
Score on Alcohol Use Disorders Identification Test (AUDIT-C)
4 months
|
4.24 score on a scale
Standard Deviation 2.00
|
4.20 score on a scale
Standard Deviation 2.14
|
|
Score on Alcohol Use Disorders Identification Test (AUDIT-C)
8 months
|
4.05 score on a scale
Standard Deviation 2.03
|
3.86 score on a scale
Standard Deviation 1.99
|
|
Score on Alcohol Use Disorders Identification Test (AUDIT-C)
12 months
|
3.94 score on a scale
Standard Deviation 2.06
|
3.75 score on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on Center for Epidemiologic Studies Depression Scale (CES-D)
4 months
|
17.30 score on a scale
Standard Deviation 10.32
|
18.66 score on a scale
Standard Deviation 11.96
|
|
Score on Center for Epidemiologic Studies Depression Scale (CES-D)
Baseline
|
22.06 score on a scale
Standard Deviation 10.91
|
21.44 score on a scale
Standard Deviation 13.83
|
|
Score on Center for Epidemiologic Studies Depression Scale (CES-D)
8 months
|
17.80 score on a scale
Standard Deviation 12.50
|
17.90 score on a scale
Standard Deviation 12.25
|
|
Score on Center for Epidemiologic Studies Depression Scale (CES-D)
12 months
|
16.82 score on a scale
Standard Deviation 12.02
|
16.64 score on a scale
Standard Deviation 11.83
|
SECONDARY outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on Beck's Anxiety Inventory (BAI)
12 months
|
9.98 score on a scale
Standard Deviation 9.91
|
9.94 score on a scale
Standard Deviation 9.98
|
|
Score on Beck's Anxiety Inventory (BAI)
Baseline
|
15.20 score on a scale
Standard Deviation 9.80
|
15.64 score on a scale
Standard Deviation 10.04
|
|
Score on Beck's Anxiety Inventory (BAI)
4 months
|
10.73 score on a scale
Standard Deviation 8.93
|
11.64 score on a scale
Standard Deviation 9.69
|
|
Score on Beck's Anxiety Inventory (BAI)
8 months
|
9.55 score on a scale
Standard Deviation 9.53
|
11.02 score on a scale
Standard Deviation 10.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on HIV Knowledge Questionnaire
Baseline
|
10.34 score on a scale
Standard Deviation 1.96
|
10.50 score on a scale
Standard Deviation 2.39
|
|
Score on HIV Knowledge Questionnaire
4 months
|
11.29 score on a scale
Standard Deviation 1.57
|
11.83 score on a scale
Standard Deviation 1.58
|
|
Score on HIV Knowledge Questionnaire
8 months
|
11.47 score on a scale
Standard Deviation 1.87
|
11.78 score on a scale
Standard Deviation 1.73
|
|
Score on HIV Knowledge Questionnaire
12 months
|
11.59 score on a scale
Standard Deviation 1.51
|
12.06 score on a scale
Standard Deviation 1.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on Alcohol Effects Questionnaire
Baseline
|
5.60 score on a scale
Standard Deviation 1.40
|
5.60 score on a scale
Standard Deviation 1.24
|
|
Score on Alcohol Effects Questionnaire
4 months
|
5.66 score on a scale
Standard Deviation 1.45
|
6.05 score on a scale
Standard Deviation 1.28
|
|
Score on Alcohol Effects Questionnaire
8 months
|
5.62 score on a scale
Standard Deviation 1.58
|
5.94 score on a scale
Standard Deviation 1.61
|
|
Score on Alcohol Effects Questionnaire
12 months
|
5.60 score on a scale
Standard Deviation 1.63
|
6.37 score on a scale
Standard Deviation 1.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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 degree of recognition of one's problems related to their drinking (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore
Baseline
|
13.92 score on a scale
Standard Deviation 6.38
|
13.93 score on a scale
Standard Deviation 5.90
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore
4 months
|
12.72 score on a scale
Standard Deviation 6.31
|
12.68 score on a scale
Standard Deviation 5.69
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore
8 months
|
11.58 score on a scale
Standard Deviation 5.77
|
12.07 score on a scale
Standard Deviation 6.10
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore
12 months
|
11.40 score on a scale
Standard Deviation 6.17
|
11.55 score on a scale
Standard Deviation 5.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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 of ambivalence (e.g., openness to reflection) related to their drinking (as opposed to unawareness) (i.e., higher scores mean a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore
Baseline
|
8.85 score on a scale
Standard Deviation 4.26
|
8.91 score on a scale
Standard Deviation 4.05
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore
4 months
|
7.88 score on a scale
Standard Deviation 3.99
|
7.92 score on a scale
Standard Deviation 4.01
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore
8 months
|
7.02 score on a scale
Standard Deviation 3.73
|
7.16 score on a scale
Standard Deviation 3.91
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore
12 months
|
6.94 score on a scale
Standard Deviation 4.00
|
7.25 score on a scale
Standard Deviation 3.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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 is making attempts to change their drinking (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore
Baseline
|
16.74 score on a scale
Standard Deviation 7.29
|
17.57 score on a scale
Standard Deviation 6.90
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore
4 months
|
17.96 score on a scale
Standard Deviation 9.20
|
18.02 score on a scale
Standard Deviation 8.27
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore
8 months
|
16.09 score on a scale
Standard Deviation 8.56
|
15.79 score on a scale
Standard Deviation 7.84
|
|
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore
12 months
|
16.51 score on a scale
Standard Deviation 9.40
|
16.34 score on a scale
Standard Deviation 8.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline.Population: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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 "Importance of statements against sex without condoms") are averaged to obtain two final subscores that range from 1 to 5. A higher "Importance of statements for sex without condoms" subscore indicates greater importance assigned to benefits of condomless anal sex (i.e., a worse outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms
Baseline
|
2.99 score on a scale
Standard Deviation 0.77
|
3.00 score on a scale
Standard Deviation 0.67
|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms
4 months
|
2.49 score on a scale
Standard Deviation 0.82
|
2.69 score on a scale
Standard Deviation 0.78
|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms
8 months
|
2.46 score on a scale
Standard Deviation 0.87
|
2.61 score on a scale
Standard Deviation 0.82
|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms
12 months
|
2.42 score on a scale
Standard Deviation 0.85
|
2.59 score on a scale
Standard Deviation 0.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
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 "Importance of statements against sex without condoms") are averaged to obtain two final subscores that range from 1 to 5. A higher "Importance of statements against sex without condoms" subscore indicates greater importance assigned to costs of condomless anal sex (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms
Baseline
|
3.20 score on a scale
Standard Deviation 0.74
|
3.15 score on a scale
Standard Deviation 0.81
|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms
4 months
|
3.26 score on a scale
Standard Deviation 0.78
|
3.27 score on a scale
Standard Deviation 0.75
|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms
8 months
|
3.23 score on a scale
Standard Deviation 0.80
|
3.27 score on a scale
Standard Deviation 0.80
|
|
Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms
12 months
|
3.16 score on a scale
Standard Deviation 0.79
|
3.17 score on a scale
Standard Deviation 0.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Self-Efficacy for Safer Sex Questionnaire is a 13-item scale that measures behavioral self-efficacy skills to increase condom use. Response options for each item range from 1="not at all confident" to 5="extremely confident" in regards to participants' confidence in avoiding condomless sex and/or negotiating condom use. Item scores are summed to obtain an overall score from 1 to 65, where a higher score indicates greater confidence in avoiding condomless sex (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Self-Efficacy for Safer Sex Questionnaire
4 months
|
44.95 score on a scale
Standard Deviation 12.29
|
42.86 score on a scale
Standard Deviation 12.55
|
|
Self-Efficacy for Safer Sex Questionnaire
Baseline
|
37.38 score on a scale
Standard Deviation 9.47
|
37.03 score on a scale
Standard Deviation 10.80
|
|
Self-Efficacy for Safer Sex Questionnaire
8 months
|
45.13 score on a scale
Standard Deviation 12.90
|
43.84 score on a scale
Standard Deviation 12.10
|
|
Self-Efficacy for Safer Sex Questionnaire
12 months
|
46.01 score on a scale
Standard Deviation 13.62
|
43.05 score on a scale
Standard Deviation 12.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 month post-baseline.Population: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Drug-Taking Confidence Questionnaire is a 50-item scale that measures behavioral self-efficacy skills to reduce alcohol use. An abbreviated 15-item version was used, which consists of the following three subscales from the original questionnaire: Urges/Temptations to Use (score range is 5 to 30), Social Pressure to Use (score range is 5 to 30), and Pleasant Times with Others (score range is 5 to 30). Responses to each item are rated from 1="not at all" to 6="completely", representing the level of confidence participants have in resisting alcohol use in each situation. Item scores within each subscale are summed to obtain the three subscores ranging from 5-30. A higher Urges/Temptations To Use subscore reflects greater confidence in resisting alcohol use when experiencing urges/temptations to use it (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore
Baseline
|
19.09 score on a scale
Standard Deviation 7.39
|
18.50 score on a scale
Standard Deviation 7.26
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore
4 months
|
22.08 score on a scale
Standard Deviation 6.68
|
20.64 score on a scale
Standard Deviation 7.23
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore
8 months
|
24.73 score on a scale
Standard Deviation 6.29
|
25.74 score on a scale
Standard Deviation 4.71
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore
12 months
|
25.69 score on a scale
Standard Deviation 5.43
|
25.48 score on a scale
Standard Deviation 4.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8-months post-baseline, and 12 months post-baseline.Population: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Drug-Taking Confidence Questionnaire is a 50-item scale that measures behavioral self-efficacy skills to reduce alcohol use. An abbreviated 15-item version was used, which consists of the following three subscales from the original questionnaire: Urges/Temptations to Use (score range is 5 to 30), Social Pressure to Use (score range is 5 to 30), and Pleasant Times with Others (score range is 5 to 30). Responses to each item are rated from 1="not at all" to 6="completely", representing the level of confidence participants have in resisting alcohol use in each situation. Item scores within each subscale are summed to obtain the three subscores ranging from 5-30. A higher Social Pressure to Use subscore reflects greater confidence in resisting alcohol use when under social pressure to use it (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore
Baseline
|
16.13 score on a scale
Standard Deviation 7.51
|
16.10 score on a scale
Standard Deviation 7.24
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore
4 months
|
18.83 score on a scale
Standard Deviation 6.84
|
18.98 score on a scale
Standard Deviation 7.67
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore
8 months
|
23.17 score on a scale
Standard Deviation 7.49
|
24.13 score on a scale
Standard Deviation 6.42
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore
12 months
|
23.83 score on a scale
Standard Deviation 6.34
|
24.11 score on a scale
Standard Deviation 5.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Drug-Taking Confidence Questionnaire is a 50-item scale that measures behavioral self-efficacy skills to reduce alcohol use. An abbreviated 15-item version was used, which consists of the following three subscales from the original questionnaire: Urges/Temptations to Use (score range is 5 to 30), Social Pressure to Use (score range is 5 to 30), and Pleasant Times with Others (score range is 5 to 30). Responses to each item are rated from 1="not at all" to 6="completely", representing the level of confidence participants have in resisting alcohol use in each situation. Item scores within each subscale are summed to obtain the three subscores ranging from 5-30. A higher Pleasant Times With Others subscore reflects greater confidence in resisting alcohol use in situations of experiencing pleasant times with others (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore
Baseline
|
16.31 score on a scale
Standard Deviation 7.15
|
15.18 score on a scale
Standard Deviation 7.03
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore
4 months
|
17.92 score on a scale
Standard Deviation 6.74
|
18.47 score on a scale
Standard Deviation 7.76
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore
8 months
|
23.19 score on a scale
Standard Deviation 6.93
|
24.33 score on a scale
Standard Deviation 5.67
|
|
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore
12 months
|
23.67 score on a scale
Standard Deviation 6.44
|
23.68 score on a scale
Standard Deviation 6.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Gay-Related Rejection Sensitivity Scale is used to measure rejection sensitivity around one's sexuality. The scale consists of 14 interpersonal situations in which such rejection may be perceived (e.g., "You bring a male partner to a family reunion. Two of your old-fashioned aunts don't come talk to you even though they see you"), each followed by a question of anxiety (e.g., "How concerned or anxious would you be that they don't talk to you because of your sexual orientation?") and likelihood (e.g., "How likely is it that they didn't talk to you because of your sexual orientation?") of gay-related rejection occurring in this case, each scored from 1="very unconcerned/unlikely" to 6="very concerned/likely". The product of the likelihood and anxiety subscales for each of the 14 items were then averaged together to achieve an overall score. The overall score ranges from 1 to 36, where a higher score indicates greater gay-related rejection sensitivity (i.e., a worse outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on Gay-Related Rejection Sensitivity Scale
8 months
|
9.57 score on a scale
Standard Deviation 7.65
|
9.83 score on a scale
Standard Deviation 7.40
|
|
Score on Gay-Related Rejection Sensitivity Scale
Baseline
|
13.44 score on a scale
Standard Deviation 7.30
|
13.64 score on a scale
Standard Deviation 7.58
|
|
Score on Gay-Related Rejection Sensitivity Scale
4 months
|
10.58 score on a scale
Standard Deviation 6.94
|
11.44 score on a scale
Standard Deviation 7.88
|
|
Score on Gay-Related Rejection Sensitivity Scale
12 months
|
8.81 score on a scale
Standard Deviation 7.44
|
8.92 score on a scale
Standard Deviation 7.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Rathus Assertiveness Schedule is a 30-item self-report which measure assertive behaviors. The items include statements like "Most people seem to be more aggressive and assertive than I am", "When I am asked to do something, I insist upon knowing why" etc. The responses ranges from -3="very uncharacteristic of me" to 3="very characteristic of me". Items 1, 2, 4, 5, 9, 11-17, 19, 23, 24, 26, and 30 are reverse-coded and the resulting 30 items are summed to attain a continuous score from -90 to 90, where a higher score indicates greater assertiveness (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on Rathus Assertiveness Schedule
8 months
|
11.02 score on a scale
Standard Deviation 22.85
|
10.05 score on a scale
Standard Deviation 25.84
|
|
Score on Rathus Assertiveness Schedule
Baseline
|
6.71 score on a scale
Standard Deviation 24.38
|
7.57 score on a scale
Standard Deviation 24.25
|
|
Score on Rathus Assertiveness Schedule
4 months
|
11.49 score on a scale
Standard Deviation 24.19
|
9.45 score on a scale
Standard Deviation 24.03
|
|
Score on Rathus Assertiveness Schedule
12 months
|
10.93 score on a scale
Standard Deviation 23.17
|
11.79 score on a scale
Standard Deviation 24.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-intervention, 8 months post-intervention, and 12 months post-intervention.Population: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The concealment motivation subscore ranges from 1-6 with higher scores indicating a greater degree of motivation to conceal one's sexual minority identity.
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore
Baseline
|
4.36 score on a scale
Standard Deviation 1.22
|
4.36 score on a scale
Standard Deviation 1.29
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore
4 months
|
4.25 score on a scale
Standard Deviation 1.28
|
4.22 score on a scale
Standard Deviation 1.21
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore
8 months
|
4.19 score on a scale
Standard Deviation 1.24
|
4.29 score on a scale
Standard Deviation 1.34
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore
12 months
|
4.23 score on a scale
Standard Deviation 1.28
|
4.17 score on a scale
Standard Deviation 1.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The internalized homonegative subscore ranges from 1-6 with higher scores indicating greater internalized homonegativity (i.e., a worse outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore
Baseline
|
2.40 score on a scale
Standard Deviation 1.30
|
2.26 score on a scale
Standard Deviation 1.24
|
|
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore
4 months
|
2.26 score on a scale
Standard Deviation 1.22
|
2.18 score on a scale
Standard Deviation 1.22
|
|
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore
8 months
|
2.34 score on a scale
Standard Deviation 1.41
|
2.20 score on a scale
Standard Deviation 1.32
|
|
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore
12 months
|
2.25 score on a scale
Standard Deviation 1.27
|
2.19 score on a scale
Standard Deviation 1.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The acceptance concerns subscore ranges from 1-6 with higher scores indicating more acceptance concerns (i.e., a worse outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore
Baseline
|
3.69 score on a scale
Standard Deviation 1.30
|
3.47 score on a scale
Standard Deviation 1.25
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore
4 months
|
3.46 score on a scale
Standard Deviation 1.21
|
3.26 score on a scale
Standard Deviation 1.35
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore
8 months
|
3.35 score on a scale
Standard Deviation 1.27
|
3.20 score on a scale
Standard Deviation 1.38
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore
12 months
|
3.31 score on a scale
Standard Deviation 1.31
|
3.02 score on a scale
Standard Deviation 1.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The identity uncertainty subscore ranges from 1-6 with higher scores indicating a greater degree of uncertainty about one's sexual minority identity.
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore
8 months
|
1.93 score on a scale
Standard Deviation 1.15
|
2.06 score on a scale
Standard Deviation 1.25
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore
Baseline
|
2.09 score on a scale
Standard Deviation 1.13
|
2.05 score on a scale
Standard Deviation 1.19
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore
4 months
|
2.01 score on a scale
Standard Deviation 1.15
|
2.09 score on a scale
Standard Deviation 1.21
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore
12 months
|
1.90 score on a scale
Standard Deviation 1.08
|
1.93 score on a scale
Standard Deviation 1.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The difficult process subscore ranges from 1-6 with higher scores indicating the participant has been having a more difficult time accepting their sexual minority identity.
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore
Baseline
|
3.66 score on a scale
Standard Deviation 1.40
|
3.42 score on a scale
Standard Deviation 1.41
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore
4 months
|
3.39 score on a scale
Standard Deviation 1.34
|
3.31 score on a scale
Standard Deviation 1.38
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore
8 months
|
3.45 score on a scale
Standard Deviation 1.35
|
3.29 score on a scale
Standard Deviation 1.39
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore
12 months
|
3.49 score on a scale
Standard Deviation 1.36
|
3.24 score on a scale
Standard Deviation 1.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The identity superiority subscore ranges from 1-6 with higher scores indicating the participant views people with a sexual minority identity as superior to heterosexual people.
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore
Baseline
|
2.21 score on a scale
Standard Deviation 1.05
|
2.32 score on a scale
Standard Deviation 1.03
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore
4 months
|
2.18 score on a scale
Standard Deviation 1.12
|
2.33 score on a scale
Standard Deviation 1.07
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore
8 months
|
2.24 score on a scale
Standard Deviation 1.14
|
2.31 score on a scale
Standard Deviation 1.11
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore
12 months
|
2.23 score on a scale
Standard Deviation 1.12
|
2.37 score on a scale
Standard Deviation 1.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The identity affirmation subscore ranges from 1-6 with higher scores indicating greater pride in one's sexual minority identity (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore
Baseline
|
4.27 score on a scale
Standard Deviation 1.30
|
4.32 score on a scale
Standard Deviation 1.21
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore
4 months
|
4.31 score on a scale
Standard Deviation 1.30
|
4.30 score on a scale
Standard Deviation 1.24
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore
8 months
|
4.13 score on a scale
Standard Deviation 1.39
|
4.46 score on a scale
Standard Deviation 1.26
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore
12 months
|
4.21 score on a scale
Standard Deviation 1.41
|
4.37 score on a scale
Standard Deviation 1.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) is a 27-item, self-reported measure that assesses an individual's sexual minority identity across eight dimensions/subscales: acceptance concerns, concealment motivation, identity uncertainty, internalized homonegativity, difficulty with the identity development process, identity superiority, identity affirmation, and identity centrality. Responses to items were scored from 1="disagree strongly" to 6="agree strongly", with items 11 and 23 being reverse-coded. Items within each subscale averaged to obtain eight final subscores. The identity centrality subscore ranges from 1-6 with higher scores indicating that one's sexual orientation is more central to one's personal identity.
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore
4 months
|
3.63 score on a scale
Standard Deviation 1.05
|
3.76 score on a scale
Standard Deviation 1.16
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore
Baseline
|
3.65 score on a scale
Standard Deviation 1.02
|
3.79 score on a scale
Standard Deviation 1.18
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore
8 months
|
3.62 score on a scale
Standard Deviation 1.16
|
3.83 score on a scale
Standard Deviation 1.17
|
|
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore
12 months
|
3.61 score on a scale
Standard Deviation 1.18
|
3.88 score on a scale
Standard Deviation 1.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The 10-item version of the LGBT Victimization Scale measures that assesses the frequency of experiences of victimization in the previous 3 months "because you are, or were thought to be, gay, lesbian, bisexual, or transgender." Items address verbal threats and insults, being chased, having property damaged, and being physically or sexually assaulted. Responses to each item/situation are scored from 0="never" to 3="3 or more times" and summed to obtain an overall score, which ranges from 0 to 30, where a higher score indicates higher frequency of victimization experiences (i.e., a worse outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on LGBT Victimization Scale
Baseline
|
2.13 score on a scale
Standard Deviation 3.24
|
2.30 score on a scale
Standard Deviation 4.50
|
|
Score on LGBT Victimization Scale
4 months
|
1.43 score on a scale
Standard Deviation 3.25
|
1.57 score on a scale
Standard Deviation 3.35
|
|
Score on LGBT Victimization Scale
8 months
|
1.08 score on a scale
Standard Deviation 3.23
|
1.37 score on a scale
Standard Deviation 4.42
|
|
Score on LGBT Victimization Scale
12 months
|
0.86 score on a scale
Standard Deviation 2.40
|
0.87 score on a scale
Standard Deviation 2.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselinePopulation: Some participants were lost to follow-up, and in some cases participants did not provide data for certain outcomes on the self-administered surveys. Therefore, at some timepoints, "Number Analyzed" may be less that 149 for Comunica arm and 151 for Education Attention Control arm.
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-reported questionnaire designed to measure perceived social support from three sources: family, friends, and a significant other. Responses are scored from 1="very strongly disagree" to 7="very strongly agree" and averaged to obtain a final score that ranges from 1 to 7, where a higher score indicates higher perceived social support (i.e., a better outcome).
Outcome measures
| Measure |
Comunică
n=149 Participants
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).
|
Education Attention Control (EAC)
n=151 Participants
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.
|
|---|---|---|
|
Score on Multidimensional Scale of Perceived Social Support (MSPSS)
12 months
|
5.03 score on a scale
Standard Deviation 1.40
|
5.10 score on a scale
Standard Deviation 1.50
|
|
Score on Multidimensional Scale of Perceived Social Support (MSPSS)
Baseline
|
4.98 score on a scale
Standard Deviation 1.27
|
4.81 score on a scale
Standard Deviation 1.35
|
|
Score on Multidimensional Scale of Perceived Social Support (MSPSS)
4 months
|
5.21 score on a scale
Standard Deviation 1.16
|
4.95 score on a scale
Standard Deviation 1.42
|
|
Score on Multidimensional Scale of Perceived Social Support (MSPSS)
8 months
|
4.94 score on a scale
Standard Deviation 1.43
|
5.01 score on a scale
Standard Deviation 1.50
|
Adverse Events
Comunică
Education Attention Control (EAC)
Serious adverse events
| Measure |
Comunică
n=149 participants at risk
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).
|
Education Attention Control (EAC)
n=151 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
1.3%
2/149 • During an assessment or counseling session, from baseline survey to 12-months post randomization
Participants were assessed as soon as a trigger was sent to the team by a score in a survey, or an event was discovered during a counseling session.
|
0.00%
0/151 • During an assessment or counseling session, from baseline survey to 12-months post randomization
Participants were assessed as soon as a trigger was sent to the team by a score in a survey, or an event was discovered during a counseling session.
|
Other adverse events
| Measure |
Comunică
n=149 participants at risk
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).
|
Education Attention Control (EAC)
n=151 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
9.4%
14/149 • During an assessment or counseling session, from baseline survey to 12-months post randomization
Participants were assessed as soon as a trigger was sent to the team by a score in a survey, or an event was discovered during a counseling session.
|
10.6%
16/151 • During an assessment or counseling session, from baseline survey to 12-months post randomization
Participants were assessed as soon as a trigger was sent to the team by a score in a survey, or an event was discovered during a counseling session.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place