Human Immunodeficiency Virus Clinical Trial
Official title:
Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Verified date | June 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 305 |
Est. completion date | January 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 16 Years and older |
Eligibility | 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; - = 3 acts of condomless anal sex with an HIV-positive or status-unknown male partner in the prior 3 months; - = 15 heavy drinking days in the prior 3 months, (e.g., binge drinking as defined by SAMHSA: = 5 standard alcoholic drinks on five occasions per 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. |
Country | Name | City | State |
---|---|---|---|
Romania | Romanian Association against AIDS (ARAS) | Bucharest | Ilfov |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Mental Health (NIMH), Yale University |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | HIV Knowledge Questionnaire | It is a 18-item, brief self-report measure of HIV-related knowledge. Respondents read each statements about HIV and indicate whether they think the statement is true or false, or they indicate that they "don't know." Cronbach's alpha ranges from 0.75-0.89. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Alcohol Effects Questionnaire | This is a 10-item scale asking about alcohol use-related knowledge (e.g., "Beer usually contains from 2-12% alcohol by volume") with responses being 0=I don't know, 1=True and 2=False. Cronbach's alpha is 0.86. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | SOCRATES Scale | The SOCRATES is a 19-item, self-administered instrument designed to assess client motivation to change drinking-related behavior. It is made up of three scales: Problem Recognition, Ambivalence, and Taking Steps. Respondents rate their agreement with each item on a 5-point Likert-type scale (from strongly disagree to strongly agree). Cronbach's alpha ranges from 0.88-0.0.96 across three subscales. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Decisional Balance (motivation to use condoms) | This 18-item scale measures one's motivation to increase condom use (e.g., "I would feel bad if my friends found out I had sex without a condom"), with response options ranging between 1=not at all to 5=extremely. Cronbach's alpha is 0.88. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Safer-Sex Self-Efficacy Questionnaire | It is a 13-item scale that measures behavioral self-efficacy skills to increase condom use. Cronbach's alpha is 0.88.
Response options range from "not at all confident" to "extremely confident" |
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Confidence in Reducing Alcohol Use Questionnaire | It is a 15-item scale that measures behavioral self-efficacy skills to reduce alcohol use. Response options are measured from 1 (not at all) to 6 (completely). Cronbach's alpha ranges from 0.79 - 0.95. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Rejection Sensitivity Scale | It is a 14 items gay-related rejection sensitivity measure. Participants first indicated how concerned or anxious they would be that the situation occurred because of their sexual orientation. They then indicated the likelihood that the situation occurred because of their sexual orientation. Cronbach's alpha is .91. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Assertiveness Scale | 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 much like me to -3 very much unlike me. Scores on the assertiveness schedule can vary from +90 to -90. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Multidimensional Measure of Sexual Minority Identity | It is a 27 items self-report that measure acceptance, concealment motivation, identity affirmation, etc. of sexual minority populations. Cronbach's alpha ranges from 0.78-0.86. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | LGBT Victimization Scale | A 10-item measure that assesses the frequency of experiences of victimization in the previous 6 months "because you are, or were thought to be, gay, lesbian, bisexual, or transgender." Items addressed verbal threats and insults, being chased, having property damaged, and being physically or sexually assaulted. Cronbach alpha is .86. | From baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Other | Multidimensional Scale of Perceived Social Support | MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. It is rated on a seven-point Likert-type scale with scores ranging from 'very strongly disagree' (1) to 'very strongly agree' (7). The MSPSS has proven to be psychometrically sound in diverse samples and to have good internal reliability and test-retest reliability, and robust factorial validity. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Primary | Timeline Followback for Online Use: (Sexual behavior) | TLFB assesses sexual behavior in the past month. It collects retrospective day-level data and has been validated for online self-administration. The TLFB has good test-retest reliability, convergent validity, and agreement with collateral reports for sexual behavior and alcohol use. Participants will report on daily partner type (e.g. primary, casual), type of sexual behavior (e.g. insertive anal), and condom use. Median cronbach's alpha is 0.96. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Primary | Timeline Followback for Online Use: (Alcohol use) | The TLFB tool will also ask participants to report on alcohol heavy use alone, and before/during sex, in the previous 30 days. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Secondary | Alcohol Use Disorders Identification Test (AUDIT-C) | The 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. A score of 4 or more is considered to indicate hazardous or harmful alcohol use. Cronbach's alpha is 0.82. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) | 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 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]). Cronbach's alpha coefficients ranging from .85 to .90 across studies. | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) | |
Secondary | Beck's Anxiety Inventory (BAI) | 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 are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). Cronbach's alpha is 0.94 | From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) |
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