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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03912753
Enrollment
300
Registered
2019-04-11
Start date
2019-05-20
Completion date
2024-01-31
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HIV, Syphilis, Chlamydia, Gonorrhea

Brief summary

The purpose of this research study is to provide help and support for mental health and human immunodeficiency virus (HIV) risk reduction among Romanian gay and bisexual men. GBM will participate in this study using mobile device (phones, tablets, or laptops) and will complete several confidential surveys and 8 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.

Detailed description

This project is designed to remedy unaddressed and interlocking HIV-prevention and mental health needs among gay and bisexual men (GBM) in the Central Eastern European country of Romania, and their underpinning stigma-related mechanisms. Rampant stigma contributes to the increasing prevalence of HIV among Romanian GBM (from under 10% in 2009 to close to 20% in 2014, by best available estimates) and keeps GBM out-of-reach of HIV-prevention services. An mHealth pilot intervention (titled Despre Mine. Despre Noi. (DMDN) translated as About Me. About Us.), which reduced Romanian GBM's risk for HIV infection while also reducing depression and alcohol abuse in an initial pre-post trial, is now ready for testing in a randomized controlled trial with a large national sample in the current study, entitled Comunică (translation: Communicate). The Comunică intervention entails eight 60-minute live chat sessions delivered by trained counselors on a mobile study platform using motivational interviewing (MI) and cognitive-behavioral skills training (CBST). First, during pre-trial (months 1-5), in collaboration with a community advisory board consisting of GBM community members, GBM-affirmative physical and mental health providers, and a technical developer, the investigators will fine-tune the Comunică intervention based on the investigators' pilot findings and evaluation interviews, and expand the original DMDN education materials for an education attention condition (EAC) that will serve as control. Second, during the intervention phase (mos 6-45), the investigators will recruit, screen, assess, and randomize GBM at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163). The conditions are content matched, and both are hosted on the study platform. While Comunică will consist of eight weekly mHealth live chat sessions, EAC will consist of eight self-administered educational modules. Third, during the follow-up phase (mos 8-55), the investigators will assess at 4, 8, and 12 months post-baseline, in a mobile fashion identical to the baseline, the primary outcome of condomless anal sex with male partners and secondary outcomes of alcohol abuse, depression, biologic HIV/STI infection, HIV/STI testing, and psychosocial mechanisms rooted in the Information-Motivation-Behavioral Skills (IMB) model (e.g., HIV/STI knowledge, condom use self-efficacy) and minority stress theory (e.g., identity concealment, internalized homophobia).

Interventions

BEHAVIORALComunică

Comunică is based on the Information-Motivation-Behavioral Skills (IMB) model of health behavior change, which postulates that individuals must possess the requisite information for enacting sexual health, motivation to change their HIV risk and alcohol use, and behavioral skills necessary for reducing their risk. Therefore, Comunică includes MI to provide accurate information about HIV transmission, alcohol abuse, and local GBM-affirmative health resources and build motivation to improve behavioral skills (via CBST). CBST is a therapeutic approach used in the treatment of various behavioral problems, such as alcohol abuse and depression and more recently HIV risk. CBST can help modify cognitions driving unhealthy behaviors, promote awareness of contextual triggers and unhealthy behavioral patterns, and teach coping skills to improve health. Comunică also draws upon minority stress theory recognizing that stigmatizing societal contexts compromise health behavior.

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.

Sponsors

Yale University
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The investigators will recruit, screen, assess, and randomize gay and bisexual men at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163).

Eligibility

Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Gay and bisexual men (GMB) will be eligible if they report: * Male sex at birth and current male identity; * At least 16 years old; * ≥ 1 act of condomless anal sex with an HIV-positive or status-unknown male partner in the prior month; * ≥ 2 heavy drinking days in the prior month; * Own a mobile device (smartphone, tablet, laptop); and * Are confirmed to be HIV-negative upon testing at study baseline.

Exclusion criteria

* GMB will be excluded if they report past-year: a) psychiatric hospitalization; b) psychotic and manic symptoms; or c) current mood-stabilizing or anti-psychotic medication prescription * Any condition that, in the principal investigators' judgment, interferes with safe study participation.

Design outcomes

Primary

MeasureTime frameDescription
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 DaysMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineTimeline 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.
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 DaysMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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.

Secondary

MeasureTime frameDescription
Score on Alcohol Use Disorders Identification Test (AUDIT-C)Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Score on Center for Epidemiologic Studies Depression Scale (CES-D)Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineCenter 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).
Score on Beck's Anxiety Inventory (BAI)Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineBeck'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).

Other

MeasureTime frameDescription
Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without CondomsMeasured 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 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).
Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without CondomsMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Self-Efficacy for Safer Sex QuestionnaireMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use SubsoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 month post-baseline.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).
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use SubscoreMeasured at baseline, 4 months post-baseline, 8-months post-baseline, and 12 months post-baseline.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).
Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Score on Gay-Related Rejection Sensitivity ScaleMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Score on Rathus Assertiveness ScheduleMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation SubscoreMeasured at baseline, 4 months post-intervention, 8 months post-intervention, and 12 months post-intervention.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.
Score on HIV Knowledge QuestionnaireMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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.
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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.
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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.
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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.
Score on LGBT Victimization ScaleMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Score on Multidimensional Scale of Perceived Social Support (MSPSS)Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
Score on Alcohol Effects QuestionnaireMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineAlcohol-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).
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).
SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps SubscoreMeasured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baselineThe 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).

Countries

Romania

Participant flow

Participants by arm

ArmCount
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).
149
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.
151
Total300

Baseline characteristics

CharacteristicComunicăEducation Attention Control (EAC)Total
Age, Continuous24.93 years
STANDARD_DEVIATION 6.55
25.87 years
STANDARD_DEVIATION 7.38
25.40 years
STANDARD_DEVIATION 6.98
Race/Ethnicity, Customized
Hungarian
10 Participants10 Participants20 Participants
Race/Ethnicity, Customized
Other
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Roma
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Romanian
137 Participants137 Participants274 Participants
Region of Enrollment
Romania
149 participants151 participants300 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
149 Participants151 Participants300 Participants
Sexual orientation
Asexual
0 Participants0 Participants0 Participants
Sexual orientation
Bisexual
49 Participants41 Participants90 Participants
Sexual orientation
Demisexual
0 Participants0 Participants0 Participants
Sexual orientation
Gay
97 Participants105 Participants202 Participants
Sexual orientation
Heterosexual
0 Participants0 Participants0 Participants
Sexual orientation
Pansexual
1 Participants1 Participants2 Participants
Sexual orientation
Queer
1 Participants1 Participants2 Participants
Sexual orientation
Uncertain / don't know for sure
1 Participants3 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1490 / 151
other
Total, other adverse events
14 / 14916 / 151
serious
Total, serious adverse events
2 / 1490 / 151

Outcome results

Primary

Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days

Timeline Followback for Online Use (TLFB), which assesses sexual behavior (condomless anal sex acts) in the past month. It collects retrospective day-level data and has been validated for online self-administration.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăNumber of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 DaysBaseline5.03 condomless anal sex actsStandard Deviation 5.47
ComunicăNumber of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days4 months3.14 condomless anal sex actsStandard Deviation 7.01
ComunicăNumber of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days8 months3.35 condomless anal sex actsStandard Deviation 6.58
ComunicăNumber of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days12 months2.35 condomless anal sex actsStandard Deviation 4.65
Education Attention Control (EAC)Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days12 months3.15 condomless anal sex actsStandard Deviation 7.43
Education Attention Control (EAC)Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 DaysBaseline6.40 condomless anal sex actsStandard Deviation 8.33
Education Attention Control (EAC)Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days8 months2.60 condomless anal sex actsStandard Deviation 6.72
Education Attention Control (EAC)Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days4 months2.37 condomless anal sex actsStandard Deviation 5.02
Primary

Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days

The Timeline Followback for Online Use (TLFB) tool will also ask participants to report occasions of heavy alcohol use (5 or more drinks) alone, and before/during sex, in the previous 30 days.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăNumber of Self-reported Days With Heavy Alcohol Use in the Last 30 DaysBaseline5.74 days with heavy alcohol useStandard Deviation 4.98
ComunicăNumber of Self-reported Days With Heavy Alcohol Use in the Last 30 Days4 months3.85 days with heavy alcohol useStandard Deviation 3.84
ComunicăNumber of Self-reported Days With Heavy Alcohol Use in the Last 30 Days8 months3.25 days with heavy alcohol useStandard Deviation 3.81
ComunicăNumber of Self-reported Days With Heavy Alcohol Use in the Last 30 Days12 months2.78 days with heavy alcohol useStandard Deviation 3.68
Education Attention Control (EAC)Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days12 months2.48 days with heavy alcohol useStandard Deviation 3.9
Education Attention Control (EAC)Number of Self-reported Days With Heavy Alcohol Use in the Last 30 DaysBaseline5.32 days with heavy alcohol useStandard Deviation 4.39
Education Attention Control (EAC)Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days8 months2.80 days with heavy alcohol useStandard Deviation 4.23
Education Attention Control (EAC)Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days4 months3.06 days with heavy alcohol useStandard Deviation 4.01
Secondary

Score on Alcohol Use Disorders Identification Test (AUDIT-C)

The Alcohol Use Disorders Identification Test (AUDIT-C) is a 3-item screening tool use to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Participants will report on standard drinks. The total score range is 0 to 12 (each item is scored 0-4), where an overall score of 4 or more is considered to indicate hazardous or harmful alcohol use. Higher scores indicate more hazardous/harmful alcohol use (i.e., a worse outcome).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on Alcohol Use Disorders Identification Test (AUDIT-C)Baseline5.14 score on a scaleStandard Deviation 2.07
ComunicăScore on Alcohol Use Disorders Identification Test (AUDIT-C)4 months4.24 score on a scaleStandard Deviation 2
ComunicăScore on Alcohol Use Disorders Identification Test (AUDIT-C)8 months4.05 score on a scaleStandard Deviation 2.03
ComunicăScore on Alcohol Use Disorders Identification Test (AUDIT-C)12 months3.94 score on a scaleStandard Deviation 2.06
Education Attention Control (EAC)Score on Alcohol Use Disorders Identification Test (AUDIT-C)12 months3.75 score on a scaleStandard Deviation 1.88
Education Attention Control (EAC)Score on Alcohol Use Disorders Identification Test (AUDIT-C)Baseline5.10 score on a scaleStandard Deviation 2.03
Education Attention Control (EAC)Score on Alcohol Use Disorders Identification Test (AUDIT-C)8 months3.86 score on a scaleStandard Deviation 1.99
Education Attention Control (EAC)Score on Alcohol Use Disorders Identification Test (AUDIT-C)4 months4.20 score on a scaleStandard Deviation 2.14
Secondary

Score on Beck's Anxiety Inventory (BAI)

Beck's Anxiety Inventory (BAI) is a brief self-report measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It consists of 21 items and respondents indicate how much they have been bothered by each symptom over the past week. Responses to each item are rated on a 4-point Likert scale and range from 0=not at all to 3=severely. Item scores are summed to obtain an overall score from 0 to 63, where higher scores indicate more anxiety symptoms (i.e., worse outcome).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on Beck's Anxiety Inventory (BAI)Baseline15.20 score on a scaleStandard Deviation 9.8
ComunicăScore on Beck's Anxiety Inventory (BAI)4 months10.73 score on a scaleStandard Deviation 8.93
ComunicăScore on Beck's Anxiety Inventory (BAI)8 months9.55 score on a scaleStandard Deviation 9.53
ComunicăScore on Beck's Anxiety Inventory (BAI)12 months9.98 score on a scaleStandard Deviation 9.91
Education Attention Control (EAC)Score on Beck's Anxiety Inventory (BAI)12 months9.94 score on a scaleStandard Deviation 9.98
Education Attention Control (EAC)Score on Beck's Anxiety Inventory (BAI)Baseline15.64 score on a scaleStandard Deviation 10.04
Education Attention Control (EAC)Score on Beck's Anxiety Inventory (BAI)8 months11.02 score on a scaleStandard Deviation 10.51
Education Attention Control (EAC)Score on Beck's Anxiety Inventory (BAI)4 months11.64 score on a scaleStandard Deviation 9.69
Secondary

Score on Center for Epidemiologic Studies Depression Scale (CES-D)

Center for Epidemiologic Studies Depression Scale (CES-D) is a self-report, standardized measure for depressive symptoms. It consists of 20 items in which respondents rate how frequently each item applied to them over the course of the past week. Ratings for each item are based on a 4-point Likert scale ranging from 0=rarely or none of the time (less than 1 day) to 3=most or all of the time (5-7 days). Item scores are summed to obtain an overall score from 0 to 60, where higher scores mean more depressive symptoms (i.e., a worse outcome).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on Center for Epidemiologic Studies Depression Scale (CES-D)Baseline22.06 score on a scaleStandard Deviation 10.91
ComunicăScore on Center for Epidemiologic Studies Depression Scale (CES-D)8 months17.80 score on a scaleStandard Deviation 12.5
ComunicăScore on Center for Epidemiologic Studies Depression Scale (CES-D)4 months17.30 score on a scaleStandard Deviation 10.32
ComunicăScore on Center for Epidemiologic Studies Depression Scale (CES-D)12 months16.82 score on a scaleStandard Deviation 12.02
Education Attention Control (EAC)Score on Center for Epidemiologic Studies Depression Scale (CES-D)12 months16.64 score on a scaleStandard Deviation 11.83
Education Attention Control (EAC)Score on Center for Epidemiologic Studies Depression Scale (CES-D)Baseline21.44 score on a scaleStandard Deviation 13.83
Education Attention Control (EAC)Score on Center for Epidemiologic Studies Depression Scale (CES-D)4 months18.66 score on a scaleStandard Deviation 11.96
Education Attention Control (EAC)Score on Center for Epidemiologic Studies Depression Scale (CES-D)8 months17.90 score on a scaleStandard Deviation 12.25
Other Pre-specified

Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others SubscoreBaseline16.31 score on a scaleStandard Deviation 7.15
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore4 months17.92 score on a scaleStandard Deviation 6.74
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore8 months23.19 score on a scaleStandard Deviation 6.93
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore12 months23.67 score on a scaleStandard Deviation 6.44
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore12 months23.68 score on a scaleStandard Deviation 6.22
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others SubscoreBaseline15.18 score on a scaleStandard Deviation 7.03
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore8 months24.33 score on a scaleStandard Deviation 5.67
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Pleasant Times With Others Subscore4 months18.47 score on a scaleStandard Deviation 7.76
Other Pre-specified

Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore8 months23.17 score on a scaleStandard Deviation 7.49
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore12 months23.83 score on a scaleStandard Deviation 6.34
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use SubscoreBaseline16.13 score on a scaleStandard Deviation 7.51
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore4 months18.83 score on a scaleStandard Deviation 6.84
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore4 months18.98 score on a scaleStandard Deviation 7.67
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore8 months24.13 score on a scaleStandard Deviation 6.42
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use SubscoreBaseline16.10 score on a scaleStandard Deviation 7.24
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Social Pressure To Use Subscore12 months24.11 score on a scaleStandard Deviation 5.96
Other Pre-specified

Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore8 months24.73 score on a scaleStandard Deviation 6.29
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use SubsoreBaseline19.09 score on a scaleStandard Deviation 7.39
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore12 months25.69 score on a scaleStandard Deviation 5.43
ComunicăConfidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore4 months22.08 score on a scaleStandard Deviation 6.68
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore12 months25.48 score on a scaleStandard Deviation 4.98
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use SubsoreBaseline18.50 score on a scaleStandard Deviation 7.26
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore8 months25.74 score on a scaleStandard Deviation 4.71
Education Attention Control (EAC)Confidence in Reducing Alcohol Use (Drug-Taking Confidence Questionnaire) - Urges/Temptations To Use Subsore4 months20.64 score on a scaleStandard Deviation 7.23
Other Pre-specified

Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms4 months3.26 score on a scaleStandard Deviation 0.78
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms8 months3.23 score on a scaleStandard Deviation 0.8
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without CondomsBaseline3.20 score on a scaleStandard Deviation 0.74
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms12 months3.16 score on a scaleStandard Deviation 0.79
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms4 months3.27 score on a scaleStandard Deviation 0.75
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without CondomsBaseline3.15 score on a scaleStandard Deviation 0.81
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms12 months3.17 score on a scaleStandard Deviation 0.79
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements Against Sex Without Condoms8 months3.27 score on a scaleStandard Deviation 0.8
Other Pre-specified

Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without CondomsBaseline2.99 score on a scaleStandard Deviation 0.77
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms8 months2.46 score on a scaleStandard Deviation 0.87
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms4 months2.49 score on a scaleStandard Deviation 0.82
ComunicăDecisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms12 months2.42 score on a scaleStandard Deviation 0.85
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms4 months2.69 score on a scaleStandard Deviation 0.78
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without CondomsBaseline3.00 score on a scaleStandard Deviation 0.67
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms12 months2.59 score on a scaleStandard Deviation 0.8
Education Attention Control (EAC)Decisional Balance (Motivation to Use Condoms): Importance of Statements for Sex Without Condoms8 months2.61 score on a scaleStandard Deviation 0.82
Other Pre-specified

Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns SubscoreBaseline3.69 score on a scaleStandard Deviation 1.3
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore4 months3.46 score on a scaleStandard Deviation 1.21
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore8 months3.35 score on a scaleStandard Deviation 1.27
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore12 months3.31 score on a scaleStandard Deviation 1.31
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore12 months3.02 score on a scaleStandard Deviation 1.26
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns SubscoreBaseline3.47 score on a scaleStandard Deviation 1.25
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore8 months3.20 score on a scaleStandard Deviation 1.38
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Acceptance Concerns Subscore4 months3.26 score on a scaleStandard Deviation 1.35
Other Pre-specified

Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation SubscoreBaseline4.36 score on a scaleStandard Deviation 1.22
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore4 months4.25 score on a scaleStandard Deviation 1.28
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore8 months4.19 score on a scaleStandard Deviation 1.24
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore12 months4.23 score on a scaleStandard Deviation 1.28
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore12 months4.17 score on a scaleStandard Deviation 1.27
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation SubscoreBaseline4.36 score on a scaleStandard Deviation 1.29
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore8 months4.29 score on a scaleStandard Deviation 1.34
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Concealment Motivation Subscore4 months4.22 score on a scaleStandard Deviation 1.21
Other Pre-specified

Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process SubscoreBaseline3.66 score on a scaleStandard Deviation 1.4
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore4 months3.39 score on a scaleStandard Deviation 1.34
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore8 months3.45 score on a scaleStandard Deviation 1.35
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore12 months3.49 score on a scaleStandard Deviation 1.36
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore12 months3.24 score on a scaleStandard Deviation 1.28
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process SubscoreBaseline3.42 score on a scaleStandard Deviation 1.41
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore8 months3.29 score on a scaleStandard Deviation 1.39
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Difficult Process Subscore4 months3.31 score on a scaleStandard Deviation 1.38
Other Pre-specified

Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore4 months4.31 score on a scaleStandard Deviation 1.3
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation SubscoreBaseline4.27 score on a scaleStandard Deviation 1.3
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore8 months4.13 score on a scaleStandard Deviation 1.39
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore12 months4.21 score on a scaleStandard Deviation 1.41
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore12 months4.37 score on a scaleStandard Deviation 1.36
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore8 months4.46 score on a scaleStandard Deviation 1.26
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation SubscoreBaseline4.32 score on a scaleStandard Deviation 1.21
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Affirmation Subscore4 months4.30 score on a scaleStandard Deviation 1.24
Other Pre-specified

Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality SubscoreBaseline3.65 score on a scaleStandard Deviation 1.02
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore8 months3.62 score on a scaleStandard Deviation 1.16
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore12 months3.61 score on a scaleStandard Deviation 1.18
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore4 months3.63 score on a scaleStandard Deviation 1.05
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore12 months3.88 score on a scaleStandard Deviation 1.18
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality SubscoreBaseline3.79 score on a scaleStandard Deviation 1.18
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore4 months3.76 score on a scaleStandard Deviation 1.16
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Centrality Subscore8 months3.83 score on a scaleStandard Deviation 1.17
Other Pre-specified

Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority SubscoreBaseline2.21 score on a scaleStandard Deviation 1.05
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore4 months2.18 score on a scaleStandard Deviation 1.12
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore8 months2.24 score on a scaleStandard Deviation 1.14
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore12 months2.23 score on a scaleStandard Deviation 1.12
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore12 months2.37 score on a scaleStandard Deviation 1.19
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority SubscoreBaseline2.32 score on a scaleStandard Deviation 1.03
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore8 months2.31 score on a scaleStandard Deviation 1.11
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Superiority Subscore4 months2.33 score on a scaleStandard Deviation 1.07
Other Pre-specified

Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty SubscoreBaseline2.09 score on a scaleStandard Deviation 1.13
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore4 months2.01 score on a scaleStandard Deviation 1.15
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore8 months1.93 score on a scaleStandard Deviation 1.15
ComunicăLesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore12 months1.90 score on a scaleStandard Deviation 1.08
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore12 months1.93 score on a scaleStandard Deviation 1.2
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty SubscoreBaseline2.05 score on a scaleStandard Deviation 1.19
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore8 months2.06 score on a scaleStandard Deviation 1.25
Education Attention Control (EAC)Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Identity Uncertainty Subscore4 months2.09 score on a scaleStandard Deviation 1.21
Other Pre-specified

Score on Alcohol Effects Questionnaire

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on Alcohol Effects QuestionnaireBaseline5.60 score on a scaleStandard Deviation 1.4
ComunicăScore on Alcohol Effects Questionnaire4 months5.66 score on a scaleStandard Deviation 1.45
ComunicăScore on Alcohol Effects Questionnaire8 months5.62 score on a scaleStandard Deviation 1.58
ComunicăScore on Alcohol Effects Questionnaire12 months5.60 score on a scaleStandard Deviation 1.63
Education Attention Control (EAC)Score on Alcohol Effects Questionnaire12 months6.37 score on a scaleStandard Deviation 1.39
Education Attention Control (EAC)Score on Alcohol Effects QuestionnaireBaseline5.60 score on a scaleStandard Deviation 1.24
Education Attention Control (EAC)Score on Alcohol Effects Questionnaire8 months5.94 score on a scaleStandard Deviation 1.61
Education Attention Control (EAC)Score on Alcohol Effects Questionnaire4 months6.05 score on a scaleStandard Deviation 1.28
Other Pre-specified

Score on Gay-Related Rejection Sensitivity Scale

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on Gay-Related Rejection Sensitivity Scale4 months10.58 score on a scaleStandard Deviation 6.94
ComunicăScore on Gay-Related Rejection Sensitivity ScaleBaseline13.44 score on a scaleStandard Deviation 7.3
ComunicăScore on Gay-Related Rejection Sensitivity Scale8 months9.57 score on a scaleStandard Deviation 7.65
ComunicăScore on Gay-Related Rejection Sensitivity Scale12 months8.81 score on a scaleStandard Deviation 7.44
Education Attention Control (EAC)Score on Gay-Related Rejection Sensitivity Scale12 months8.92 score on a scaleStandard Deviation 7.57
Education Attention Control (EAC)Score on Gay-Related Rejection Sensitivity Scale8 months9.83 score on a scaleStandard Deviation 7.4
Education Attention Control (EAC)Score on Gay-Related Rejection Sensitivity ScaleBaseline13.64 score on a scaleStandard Deviation 7.58
Education Attention Control (EAC)Score on Gay-Related Rejection Sensitivity Scale4 months11.44 score on a scaleStandard Deviation 7.88
Other Pre-specified

Score on HIV Knowledge Questionnaire

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on HIV Knowledge QuestionnaireBaseline10.34 score on a scaleStandard Deviation 1.96
ComunicăScore on HIV Knowledge Questionnaire4 months11.29 score on a scaleStandard Deviation 1.57
ComunicăScore on HIV Knowledge Questionnaire8 months11.47 score on a scaleStandard Deviation 1.87
ComunicăScore on HIV Knowledge Questionnaire12 months11.59 score on a scaleStandard Deviation 1.51
Education Attention Control (EAC)Score on HIV Knowledge Questionnaire12 months12.06 score on a scaleStandard Deviation 1.24
Education Attention Control (EAC)Score on HIV Knowledge QuestionnaireBaseline10.50 score on a scaleStandard Deviation 2.39
Education Attention Control (EAC)Score on HIV Knowledge Questionnaire8 months11.78 score on a scaleStandard Deviation 1.73
Education Attention Control (EAC)Score on HIV Knowledge Questionnaire4 months11.83 score on a scaleStandard Deviation 1.58
Other Pre-specified

Score on LGBT Victimization Scale

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on LGBT Victimization Scale8 months1.08 score on a scaleStandard Deviation 3.23
ComunicăScore on LGBT Victimization Scale4 months1.43 score on a scaleStandard Deviation 3.25
ComunicăScore on LGBT Victimization Scale12 months0.86 score on a scaleStandard Deviation 2.4
ComunicăScore on LGBT Victimization ScaleBaseline2.13 score on a scaleStandard Deviation 3.24
Education Attention Control (EAC)Score on LGBT Victimization Scale12 months0.87 score on a scaleStandard Deviation 2.53
Education Attention Control (EAC)Score on LGBT Victimization Scale4 months1.57 score on a scaleStandard Deviation 3.35
Education Attention Control (EAC)Score on LGBT Victimization Scale8 months1.37 score on a scaleStandard Deviation 4.42
Education Attention Control (EAC)Score on LGBT Victimization ScaleBaseline2.30 score on a scaleStandard Deviation 4.5
Other Pre-specified

Score on Multidimensional Scale of Perceived Social Support (MSPSS)

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on Multidimensional Scale of Perceived Social Support (MSPSS)Baseline4.98 score on a scaleStandard Deviation 1.27
ComunicăScore on Multidimensional Scale of Perceived Social Support (MSPSS)4 months5.21 score on a scaleStandard Deviation 1.16
ComunicăScore on Multidimensional Scale of Perceived Social Support (MSPSS)8 months4.94 score on a scaleStandard Deviation 1.43
ComunicăScore on Multidimensional Scale of Perceived Social Support (MSPSS)12 months5.03 score on a scaleStandard Deviation 1.4
Education Attention Control (EAC)Score on Multidimensional Scale of Perceived Social Support (MSPSS)12 months5.10 score on a scaleStandard Deviation 1.5
Education Attention Control (EAC)Score on Multidimensional Scale of Perceived Social Support (MSPSS)Baseline4.81 score on a scaleStandard Deviation 1.35
Education Attention Control (EAC)Score on Multidimensional Scale of Perceived Social Support (MSPSS)8 months5.01 score on a scaleStandard Deviation 1.5
Education Attention Control (EAC)Score on Multidimensional Scale of Perceived Social Support (MSPSS)4 months4.95 score on a scaleStandard Deviation 1.42
Other Pre-specified

Score on Rathus Assertiveness Schedule

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăScore on Rathus Assertiveness ScheduleBaseline6.71 score on a scaleStandard Deviation 24.38
ComunicăScore on Rathus Assertiveness Schedule4 months11.49 score on a scaleStandard Deviation 24.19
ComunicăScore on Rathus Assertiveness Schedule8 months11.02 score on a scaleStandard Deviation 22.85
ComunicăScore on Rathus Assertiveness Schedule12 months10.93 score on a scaleStandard Deviation 23.17
Education Attention Control (EAC)Score on Rathus Assertiveness Schedule12 months11.79 score on a scaleStandard Deviation 24.98
Education Attention Control (EAC)Score on Rathus Assertiveness ScheduleBaseline7.57 score on a scaleStandard Deviation 24.25
Education Attention Control (EAC)Score on Rathus Assertiveness Schedule8 months10.05 score on a scaleStandard Deviation 25.84
Education Attention Control (EAC)Score on Rathus Assertiveness Schedule4 months9.45 score on a scaleStandard Deviation 24.03
Other Pre-specified

Self-Efficacy for Safer Sex Questionnaire

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăSelf-Efficacy for Safer Sex QuestionnaireBaseline37.38 score on a scaleStandard Deviation 9.47
ComunicăSelf-Efficacy for Safer Sex Questionnaire8 months45.13 score on a scaleStandard Deviation 12.9
ComunicăSelf-Efficacy for Safer Sex Questionnaire12 months46.01 score on a scaleStandard Deviation 13.62
ComunicăSelf-Efficacy for Safer Sex Questionnaire4 months44.95 score on a scaleStandard Deviation 12.29
Education Attention Control (EAC)Self-Efficacy for Safer Sex Questionnaire12 months43.05 score on a scaleStandard Deviation 12.62
Education Attention Control (EAC)Self-Efficacy for Safer Sex Questionnaire8 months43.84 score on a scaleStandard Deviation 12.1
Education Attention Control (EAC)Self-Efficacy for Safer Sex Questionnaire4 months42.86 score on a scaleStandard Deviation 12.55
Education Attention Control (EAC)Self-Efficacy for Safer Sex QuestionnaireBaseline37.03 score on a scaleStandard Deviation 10.8
Other Pre-specified

SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence SubscoreBaseline8.85 score on a scaleStandard Deviation 4.26
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore4 months7.88 score on a scaleStandard Deviation 3.99
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore8 months7.02 score on a scaleStandard Deviation 3.73
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore12 months6.94 score on a scaleStandard Deviation 4
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore12 months7.25 score on a scaleStandard Deviation 3.94
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence SubscoreBaseline8.91 score on a scaleStandard Deviation 4.05
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore8 months7.16 score on a scaleStandard Deviation 3.91
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Ambivalence Subscore4 months7.92 score on a scaleStandard Deviation 4.01
Other Pre-specified

SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition SubscoreBaseline13.92 score on a scaleStandard Deviation 6.38
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore8 months11.58 score on a scaleStandard Deviation 5.77
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore12 months11.40 score on a scaleStandard Deviation 6.17
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore4 months12.72 score on a scaleStandard Deviation 6.31
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore12 months11.55 score on a scaleStandard Deviation 5.82
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition SubscoreBaseline13.93 score on a scaleStandard Deviation 5.9
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore4 months12.68 score on a scaleStandard Deviation 5.69
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Problem Recognition Subscore8 months12.07 score on a scaleStandard Deviation 6.1
Other Pre-specified

SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore8 months16.09 score on a scaleStandard Deviation 8.56
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps SubscoreBaseline16.74 score on a scaleStandard Deviation 7.29
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore12 months16.51 score on a scaleStandard Deviation 9.4
ComunicăSOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore4 months17.96 score on a scaleStandard Deviation 9.2
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore12 months16.34 score on a scaleStandard Deviation 8.63
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore4 months18.02 score on a scaleStandard Deviation 8.27
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps Subscore8 months15.79 score on a scaleStandard Deviation 7.84
Education Attention Control (EAC)SOCRATES (Stages of Change Readiness and Treatment Eagerness Scale) - Taking Steps SubscoreBaseline17.57 score on a scaleStandard Deviation 6.9
Other Pre-specified

The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ComunicăThe Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity SubscoreBaseline2.40 score on a scaleStandard Deviation 1.3
ComunicăThe Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore4 months2.26 score on a scaleStandard Deviation 1.22
ComunicăThe Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore8 months2.34 score on a scaleStandard Deviation 1.41
ComunicăThe Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore12 months2.25 score on a scaleStandard Deviation 1.27
Education Attention Control (EAC)The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore12 months2.19 score on a scaleStandard Deviation 1.28
Education Attention Control (EAC)The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity SubscoreBaseline2.26 score on a scaleStandard Deviation 1.24
Education Attention Control (EAC)The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore8 months2.20 score on a scaleStandard Deviation 1.32
Education Attention Control (EAC)The Lesbian, Gay, and Bisexual Identity Scale (LGBIS) - Internalized Homonegativity Subscore4 months2.18 score on a scaleStandard Deviation 1.22

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026